Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 194
Filter
1.
Heliyon ; 10(13): e33809, 2024 Jul 15.
Article in English | MEDLINE | ID: mdl-39040319

ABSTRACT

The traditional free-range system of livestock rearing contributes to the socioeconomic well-being of most rural households in Ghana. The traditional management system exposes livestock to a high disease incidence, but healthcare support for animal production is limited. Ethnoveterinary practice is an integral part of livestock treatment, particularly in rural communities where veterinary services are poor. However, documentation of the plants used for ethnoveterinary treatment of livestock is scant in the country. Given the dearth of information on ethnoveterinary treatment, this study aimed to document the cultural significance and level of agreement of plant species used for treating livestock ailments in the Adaklu district. Ethnoveterinary data were collected from 120 respondents using semi-structured questionnaires. Quantitative ethnobotanical indices were used to ascertain the most culturally significant plant species for livestock healing. It was found that 38 plant species were used to treat various livestock ailments. Ethnobotanical indices revealed that Mangifera indica, Elaeis guineensis, Khaya senegalensis, Spondias mombin, and Physalis peruviana were the most culturally significant plant species for treating livestock ailments. Mangifera indica was found to be the most versatile species for treating livestock ailments and had the highest cultural importance (CI). This study reveals the high cultural importance of plants in the Adaklu district to improve livestock healthcare. The perceived efficacy influences the selection and utilization of a resource for folk medicine. The study recommends isolating and characterizing the active compounds in the most culturally significant plants and testing the properties on the medical conditions attributed to these plants.

2.
J Spinal Cord Med ; : 1-10, 2024 Jul 22.
Article in English | MEDLINE | ID: mdl-39037335

ABSTRACT

OBJECTIVE: Polypharmacy in spinal cord injury (SCI) is common and predisposes patients to increased risk of adverse events. Evaluation of long-term health consequences and economic burden of polypharmacy in patients with SCI is explored. DESIGN: Retrospective cohort. METHODS: The IBM Marketscan Research Databases claims-based dataset was queried to search for adult patients with SCI with a 2-year follow-up. PARTICIPANTS: Two matched cohorts were analyzed: those with and without polypharmacy, analyzing index hospitalization, readmissions, payments, and health outcomes. RESULTS: A total of 11 569 individuals with SCI were included, of which 7235 (63%) were in the polypharmacy group who took a median of 11 separate drugs over two years. Opioid analgesics were the most common medication, present in 57% of patients with SCI meeting the criteria of polypharmacy, followed by antidepressant medications (46%) and muscle relaxants (40%). Risk of pneumonia was increased for the polypharmacy group (58%) compared to the non-polypharmacy group (45%), as were urinary tract infection (79% versus 63%), wound infection (30% versus 21%), depression (76% versus 57%), and adverse drug events (24% versus 15%) at 2 years. Combined median healthcare payments were higher in polypharmacy at 2 years ($44 333 vs. $10 937, P < .0001). CONCLUSION: Majority of individuals with SCI met the criteria for polypharmacy with nearly 60% of those prescribed opioids and taking drugs from high-risk side effect profiles. Polypharmacy in SCI was associated with a greater risk of pneumonia, depression, urinary tract infections, adverse drug events, and emergency room visits over two years with four times higher overall healthcare payments at 1-year post-injury.

3.
Spinal Cord Ser Cases ; 10(1): 44, 2024 Jul 08.
Article in English | MEDLINE | ID: mdl-38977671

ABSTRACT

STUDY DESIGN: prospective case series of Yucatan miniature pig spinal cord contusion injury model with comparison to human cases of spinal cord injury (SCI). OBJECTIVES: to describe magnetic resonance imaging (MRI) measures of spinal cord lesion severity along with estimates of lateral corticospinal tracts spared neural tissue in both a less severe and more severe contusion SCI model, as well as to describe their corresponding behavioral outcome changes. SETTING: University laboratory setting. METHODS: Following a more severe and less severe SCI, each pig underwent spinal cord MRI to measure lesion characteristics, along with locomotor and urodynamics outcomes testing. RESULTS: In the pig with more severe SCI, locomotor and urodynamic outcomes were poor, and both the spinal cord lesion volume and damage estimates to the lateral corticospinal tracts were large. Conversely, in the pig with less severe SCI, locomotor and urodynamic outcomes were favorable, with the spinal cord lesion volume and damage estimates to the lateral corticospinal tracts being less pronounced. For two human cases matched on estimates of damage to the lateral corticospinal tract regions, the clinical presentations were similar to the pig outcomes, with more limited mobility and more limited bladder functional independence in the more severe case. CONCLUSIONS: Our initial findings contribute valuable insights to the emergent field of MRI-based evaluation of spinal cord lesions in pig models, offering a promising avenue for understanding and potentially improving outcomes in spinal cord injuries.


Subject(s)
Disease Models, Animal , Magnetic Resonance Imaging , Spinal Cord Injuries , Swine, Miniature , Animals , Spinal Cord Injuries/diagnostic imaging , Spinal Cord Injuries/physiopathology , Spinal Cord Injuries/pathology , Swine , Magnetic Resonance Imaging/methods , Humans , Female , Pyramidal Tracts/diagnostic imaging , Pyramidal Tracts/pathology , Male , Behavior, Animal/physiology , Spinal Cord/diagnostic imaging , Spinal Cord/pathology , Spinal Cord/physiopathology , Recovery of Function/physiology , Prospective Studies , Locomotion/physiology
4.
Epilepsia ; 2024 Jun 29.
Article in English | MEDLINE | ID: mdl-38943543

ABSTRACT

OBJECTIVES: A surgical "treatment gap" in pediatric epilepsy persists despite the demonstrated safety and effectiveness of surgery. For this reason, the national surgical landscape should be investigated such that an updated assessment may more appropriately guide health care efforts. METHODS: In our retrospective cross-sectional observational study, the National Inpatient Sample (NIS) database was queried for individuals 0 to <18 years of age who had an International Classification of Diseases (ICD) code for drug-resistant epilepsy (DRE). This cohort was then split into a medical group and a surgical group. The former was defined by ICD codes for -DRE without an accompanying surgical code, and the latter was defined by DRE and one of the following epilepsy surgeries: any open surgery; laser interstitial thermal therapy (LITT); vagus nerve stimulation; or responsive neurostimulation (RNS) from 1998 to 2020. Demographic variables of age, gender, race, insurance type, hospital charge, and hospital characteristics were analyzed between surgical options. Continuous variables were analyzed with weight-adjusted quantile regression analysis, and categorical variables were analyzed by weight-adjusted counts with percentages and compared with weight-adjusted chi-square test results. RESULTS: These data indicate an increase in epilepsy surgeries over a 22-year period, primarily due to a statistically significant increase in open surgery and a non-significant increase in minimally invasive techniques, such as LITT and RNS. There are significant differences in age, race, gender, insurance type, median household income, Elixhauser index, hospital setting, and size between the medical and surgical groups, as well as the procedure performed. SIGNIFICANCE: An increase in open surgery and minimally invasive surgeries (LITT and RNS) account for the overall rise in pediatric epilepsy surgery over the last 22 years. A positive inflection point in open surgery is seen in 2005. Socioeconomic disparities exist between medical and surgical groups. Patient and hospital sociodemographics show significant differences between the procedure performed. Further efforts are required to close the surgical "treatment gap."

5.
Neurotrauma Rep ; 5(1): 28-36, 2024.
Article in English | MEDLINE | ID: mdl-38249325

ABSTRACT

Alcohol use disorder (AUD) increases risk of traumatic spinal cord injury (SCI) and is associated with depression, anxiety, and chronic pain. Given that these neuropsychiatric morbidities are frequently observed in SCI patients, the effects of pre-injury AUD on risk of depression, anxiety, or chronic pain were analyzed using an insurance claim database. Of 10,591 traumatic SCI patients, 507 had AUD-associated claims in a 12-month period before injury. Those AUD-positive SCI patients showed distinct demographic characteristics, including greater representation of men, younger age, more comorbidities, lower coverage by commercial insurance, and more cervical-level injuries. The AUD group also showed elevated pre-injury comorbidity of depression, anxiety, and chronic pain. However, multi-regression analysis revealed an increased odds ratio (OR) of de novo diagnosis of post-SCI depression in AUD patients 6 months (1.671; 95% confidence interval [CI]: 1.124, 2.483) and 1 year post-injury (1.511; 95% CI: 1.071, 2.131). The OR of de novo post-SCI anxiety was unaffected by pre-injury AUD. Finally, 1 year after SCI, pre-injury AUD increased the OR of de novo diagnosis of post-injury chronic pain (1.545; 95% CI: 1.223, 1.951). Thus, pre-injury AUD may be a risk factor for development of depression and chronic pain after traumatic SCI.

6.
World Neurosurg ; 184: e185-e194, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38278210

ABSTRACT

BACKGROUND: Spontaneous spinal hematoma (SSH) is a debilitating complication in patients taking either antiplatelet (AP) or anticoagulation (AC) medications. SSH is rare and, therefore, a systematic review is warranted to re-examine and outline trends, clinical characteristics, and outcomes associated with SSH formation. METHODS: PubMed, EMBASE, Scopus, and Web-of-Science were searched. Studies reporting clinical data of patients with SSH using AC medications were included. In addition, clinical studies meeting our a priori inclusion criteria limited to SSH were further defined in quality through risk bias assessment. RESULTS: We included 10 studies with 259 patients' pooled data post-screening 3083 abstracts. Within the cohort (n = 259), the prevalence of idiopathic, nontraumatic SSH with concomitant treatment with AC medications was greater 191 (73.75%) compared with AP treatment (27%). The lumbar spine was the most common site of hematoma (41.70%), followed by the cervical (22.01%) and thoracic (8.49%) spine. Most patients had surgical intervention (70.27%), and 29.73% had conservative management. The pooled data suggest that immediate diagnosis and intervention are the best prognostic factors in clinical outcomes. American Spinal Injury Association grading at initial symptom onset and post-treatment showed the greatest efficacy in symptomatic relief (87.64%) and return of motor and sensory symptoms (39.19%). CONCLUSIONS: Our review suggested that AC medications were related to SSH in most patients (74%), followed by APs (27%) and combined ACs + APs (1.9%). We recommend prompt intervention, a high suspicion for patients with neurologic deficits and diagnostic imaging before intervention to determine a case-specific treatment plan.

7.
Spine (Phila Pa 1976) ; 49(4): E28-E45, 2024 Feb 15.
Article in English | MEDLINE | ID: mdl-37962203

ABSTRACT

STUDY DESIGN: A retrospective cohort study. OBJECTIVE: To identify differences in complication rates after cervical and lumbar fusion over the first postoperative year between those with and without cannabis use disorder (CUD) and to assess how CUD affects opioid prescription patterns. SUMMARY OF BACKGROUND DATA: Cannabis is legal for medical purposes in 36 states and for recreational use in 18 states. Cannabis has multisystem effects and may contribute to transient vasoconstrictive, prothrombotic, and inflammatory effects. METHODS: The IBM MarketScan Database (2009-2019) was used to identify patients who underwent cervical or lumbar fusions, with or without CUD. Exact match hospitalization and postdischarge outcomes were analyzed at index, six, and 12 months. RESULTS: Of 72,024 cervical fusion (2.0% with CUD) and 105,612 lumbar fusion patients (1.5% with CUD), individuals with CUD were more likely to be young males with higher Elixhauser index. The cervical CUD group had increased neurological complications (3% vs. 2%) and sepsis (1% vs. 0%) during the index hospitalization and neurological (7% vs. 5%) and wound complications (5% vs. 3%) at 12 months. The lumbar CUD group had increased wound (8% vs. 5%) and myocardial infarction (MI) (2% vs. 1%) complications at six months and at 12 months. For those with cervical myelopathy, increased risk of pulmonary complications was observed with CUD at index hospitalization and 12-month follow-up. For those with lumbar stenosis, cardiac complications and MI were associated with CUD at index hospitalization and 12 months. CUD was associated with opiate use disorder, decreasing postoperatively. CONCLUSIONS: No differences in reoperation rates were observed for CUD groups undergoing cervical or lumbar fusion. CUD was associated with an increased risk of stroke for the cervical fusion cohort and cardiac (including MI) and pulmonary complications for lumbar fusion at index hospitalization and six and 12 months postoperatively. Opiate use disorder and decreased opiate dependence after surgery also correlated with CUD.


Subject(s)
Marijuana Abuse , Opiate Alkaloids , Spinal Diseases , Spinal Fusion , Substance-Related Disorders , Male , Humans , Retrospective Studies , Aftercare , Lumbar Vertebrae/surgery , Patient Discharge , Spinal Fusion/adverse effects , Spinal Diseases/etiology , Patient Acceptance of Health Care , Postoperative Complications/etiology
8.
J Neurooncol ; 164(3): 655-662, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37792220

ABSTRACT

BACKGROUND: Patients with a prior malignancy are at elevated risk of developing subsequent primary malignancies (SPMs). However, the risk of developing subsequent primary glioblastoma (SPGBM) in patients with a prior cancer history is poorly understood. METHODS: We used the Surveillance, Epidemiology, and End Results (SEER) database and identified patients diagnosed with non-CNS malignancy between 2000 and 2018. We calculated a modified standardized incidence ratio (M-SIR), defined as the ratio of the incidence of SPGBM among patients with initial non-CNS malignancy to the incidence of GBM in the general population, stratified by sex latency, and initial tumor location. RESULTS: Of the 5,326,172 patients diagnosed with a primary non-CNS malignancy, 3559 patients developed SPGBM (0.07%). Among patients with SPGBM, 2312 (65.0%) were men, compared to 2,706,933 (50.8%) men in the total primary non-CNS malignancy cohort. The median age at diagnosis of SPGBM was 65 years. The mean latency between a prior non-CNS malignancy and developing a SPGBM was 67.3 months (interquartile range [IQR] 27-100). Overall, patients with a primary non-CNS malignancy had a significantly elevated M-SIR (1.13, 95% CI 1.09-1.16), with a 13% increased incidence of SPGBM when compared to the incidence of developing GBM in the age-matched general population. When stratified by non-CNS tumor location, patients diagnosed with primary melanoma, lymphoma, prostate, breast, renal, or endocrine malignancies had a higher M-SIR (M-SIR ranges: 1.09-2.15). Patients with lung cancers (M-SIR 0.82, 95% CI 0.68-0.99), or stomach cancers (M-SIR 0.47, 95% CI 0.24-0.82) demonstrated a lower M-SIR. CONCLUSION: Patients with a history of prior non-CNS malignancy are at an overall increased risk of developing SPGBM relative to the incidence of developing GBM in the general population. However, the incidence of SPGBM after prior non-CNS malignancy varies by primary tumor location, with some non-CNS malignancies demonstrating either increased or decreased predisposition for SPGBM depending on tumor origin. These findings merit future investigation into whether these relationships represent treatment effects or a previously unknown shared predisposition for glioblastoma and non-CNS malignancy.


Subject(s)
Glioblastoma , Lymphoma , Neoplasms, Second Primary , Male , Humans , Aged , Female , Glioblastoma/epidemiology , Glioblastoma/complications , SEER Program , Neoplasms, Second Primary/etiology , Lymphoma/complications , Incidence , Risk Factors
9.
Heliyon ; 9(9): e19579, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37809618

ABSTRACT

Local markets are primarily the center for trade and distribution of fruits and vegetables in Ghana. Fruit and vegetable vendors are responsible for keeping food hygienic and safe from contamination. However, little is known about fruit and vegetable vendors' knowledge, attitudes, and practices (KAP) toward food hygiene and safety in local markets. This study aimed to assess the KAP of fruit and vegetable vendors in Ho City. Data on KAP was collected from 113 fruit and vegetable vendors in the Ho Central Market using a structured questionnaire. The data was analyzed using a two-way multivariate analysis of variance (MANOVA) and one-way analysis of variance (ANOVA) to examine the association of demographic variables with knowledge, attitude, and practice of food hygiene and safety. A correlation analysis was conducted to determine the intercorrelation among the KAP variables. The results suggest significant differences for vendors with medical examination certificates on knowledge (Wilks = 0.60, F = 2.82, p˂0.00), attitude (Wilks = 0.71, F = 2.10, p˂0.01), and practice (Wilks = 0.59, F = 1.79, p˂0.01). A significant correlation was found between the three domains, but the influence of knowledge and attitude on practice was weak. Fruit and vegetable vendors' knowledge and attitudes toward food hygiene and safety were supportive and favorable. However, some practices were not supportive and encouraging toward food hygiene and safety. The lack of basic amenities in the market influenced the practice of vendors. Improved environmental sanitation conditions at local markets are vital to the practice of food hygiene and safety to prevent foodborne diseases.

10.
Ann Clin Transl Neurol ; 10(9): 1647-1661, 2023 09.
Article in English | MEDLINE | ID: mdl-37501362

ABSTRACT

OBJECTIVES: To explore filtered diffusion-weighted imaging (fDWI), in comparison with conventional magnetic resonance imaging (MRI) and diffusion tensor imaging (DTI), as a predictor for long-term locomotor and urodynamic (UD) outcomes in Yucatan minipig model of spinal cord injury (SCI). Additionally, electrical conductivity of neural tissue using D-waves above and below the injury was measured to assess correlations between fDWI and D-waves data. METHODS: Eleven minipigs with contusion SCI at T8-T10 level underwent MRI at 3T 4 h. post-SCI. Parameters extracted from region of interest analysis included Daxial from fDWI at injury site, fractional anisotropy and radial diffusivity from DTI above the injury site along with measures of edema length and cord width at injury site from T2 -weighted images. Locomotor recovery was assessed pre- and weekly post-SCI through porcine thoracic injury behavior scale (PTIBS) and UD were performed pre- and at 12 weeks of SCI. D-waves latency and amplitude differences were recorded before and immediately after SCI. RESULTS: Two groups of pigs were found based on the PTIBS at week 12 (p < 0.0001) post-SCI and were labeled "poor" and "good" recovery. D-waves amplitude decreased below injury and increased above injury. UD outcomes pre/post SCI changed significantly. Conventional MRI metrics from T2 -weighted images were significantly correlated with diffusion MRI metrics. Daxial at injury epicenter was diminished by over 50% shortly after SCI, and it differentiated between good and poor locomotor recovery and UD outcomes. INTERPRETATION: Similar to small animal studies, fDWI from acute imaging after SCI is a promising predictor for functional outcomes in large animals.


Subject(s)
Contusions , Spinal Cord Injuries , Animals , Swine , Diffusion Tensor Imaging/methods , Swine, Miniature , Diffusion Magnetic Resonance Imaging/methods , Spinal Cord Injuries/diagnostic imaging
11.
J Spinal Cord Med ; : 1-16, 2023 Jul 11.
Article in English | MEDLINE | ID: mdl-37432058

ABSTRACT

CONTEXT/OBJECTIVE: Depression is the most common psychological comorbidity associated with spinal cord injury (SCI) and affects healthcare utilization and costs. This study aimed to use an International Classification of Disease (ICD) and prescription drug-based depression phenotypes to classify people with SCI, and to evaluate the prevalence of those phenotypes, associated risk factors, and healthcare utilization. DESIGN: Retrospective Observational Study. SETTING: Marketscan Database (2000-2019). PARTICIPANTS: Individuals with SCI were classified into six ICD-9/10, and prescription drugs defined phenotypes: Major Depressive Disorder (MDD), Other Depression (OthDep), Antidepressants for Other Psychiatric Conditions (PsychRx), Antidepressants for non-psychiatric condition (NoPsychRx), Other Non-depression Psychiatric conditions only (NonDepPsych), and No Depression (NoDep). Except for the latter, all the other groups were referred to as "depressed phenotypes". Data were screened for 24 months pre- and 24 months post-injury depression. INTERVENTIONS: None. OUTCOME MEASURES: Healthcare utilization and payments. RESULTS: There were 9,291 patients with SCI classified as follows: 16% MDD, 11% OthDep, 13% PsychRx, 13% NonPsychRx, 14% NonDepPsych, 33% NoDep. Compared with the NoDep group, the MDD group was younger (54 vs. 57 years old), predominantly female (55% vs. 42%), with Medicaid coverage (42% vs. 12%), had increased comorbidities (69% vs. 54%), had fewer traumatic injuries (51% vs. 54%) and had higher chronic 12-month pre-SCI opioid use (19% vs. 9%) (all P < 0.0001). Classification into a depressed phenotype before SCI was found to be significantly associated with depression phenotype post-SCI, as evidenced by those who experienced a negative change (37%) vs. a positive change (15%, P < 0.0001). Patients in the MDD cohort had higher healthcare utilization and associated payments at 12 and 24 months after SCI. CONCLUSION: Increasing awareness of psychiatric history and MDD risk factors may improve identifying and managing higher-risk patients with SCI, ultimately optimizing their post-injury healthcare utilization and cost. This method of classifying depression phenotypes provides a simple and practical way to obtain this information by screening through pre-injury medical records.

12.
Med Lav ; 114(3): e2023024, 2023 Jun 12.
Article in English | MEDLINE | ID: mdl-37309882

ABSTRACT

BACKGROUND: The construction industry has a percentage of work-related injuries and fatalities. Workers' perception of occupational hazards exposure can be a proactive management tool in knowing the state of construction site safety performance. This study aimed to assess the hazard perception of on-site construction workers in Ghana. METHODS: Using a structured questionnaire, data was collected from 197 construction workers at live building sites in the Ho Municipality. The data were analyzed using the Relative Importance Index (RII) approach. RESULTS: The study revealed that on-site construction workers perceived ergonomic hazards as the most frequent, followed by physical, phycological, biological, and chemical hazards. The importance level of RII revealed that long working hours and bending or twisting back during task performance were perceived as the most severe hazards. Long working hours had the highest overall RII ranking, followed by bending or twisting back during task performance, manual lifting of objects or loads, scorching temperatures, and lengthy standing for prolonged periods. CONCLUSIONS: Given the adverse health effects of working for long hours, the management of Ghanaian construction industries needs to reinforce the legislation on working hours to safeguard workers' occupational health. Safety professionals can use the study's findings to improve safety performance in the Ghanaian construction industry.


Subject(s)
Construction Industry , Humans , Ghana , Ergonomics , Fenbendazole , Perception
13.
Biomedicines ; 11(6)2023 Jun 07.
Article in English | MEDLINE | ID: mdl-37371755

ABSTRACT

Gastrointestinal (GI) complications, including motility disorders, metabolic deficiencies, and changes in gut microbiota following spinal cord injury (SCI), are associated with poor outcomes. After SCI, the autonomic nervous system becomes unbalanced below the level of injury and can lead to severe GI dysfunction. The SmartPill™ is a non-invasive capsule that, when ingested, transmits pH, temperature, and pressure readings that can be used to assess effects in GI function post-injury. Our minipig model allows us to assess these post-injury changes to optimize interventions and ultimately improve GI function. The aim of this study was to compare pre-injury to post-injury transit times, pH, and pressures in sections of GI tract by utilizing the SmartPill™ in three pigs after SCI at 2 and 6 weeks. Tributyrin was administered to two pigs to assess the influences on their gut microenvironment. We observed prolonged GET (Gastric Emptying Time) and CTT (Colon Transit Time), decreases in contraction frequencies (Con freq) in the antrum of the stomach, colon, and decreases in duodenal pressures post-injury. We noted increases in Sum amp generated at 2 weeks post-injury in the colon, with corresponding decreases in Con freq. We found transient changes in pH in the colon and small intestine at 2 weeks post-injury, with minimal effect on stomach pH post-injury. Prolonged GETs and CTTs can influence the absorptive profile in the gut and contribute to pathology development. This is the first pilot study to administer the SmartPill™ in minipigs in the context of SCI. Further investigations will elucidate these trends and characterize post-SCI GI function.

14.
J Neurotrauma ; 40(17-18): 1889-1906, 2023 09.
Article in English | MEDLINE | ID: mdl-37130044

ABSTRACT

To date, no drug therapy has shown significant efficacy in improving functional outcomes in patients with acute spinal cord injury (SCI). Riluzole is an approved benzothiazole sodium channel blocker to attenuate neurodegeneration in amyotrophic lateral sclerosis (ALS) and is of interest for neuroprotection in SCI. In a Phase I clinical trial (ClinicalTrials.gov Identifier: NCT00876889), riluzole was well tolerated with a 2-week treatment at the dose level approved for ALS and exhibited potential efficacy in patients with SCI. The acute and progressive nature of traumatic SCI and the complexity of secondary injury processes alter the pharmacokinetics (PK) of therapeutics. In the PK sub-study of the multi-center, randomized, placebo-controlled, double-blinded Riluzole in Spinal Cord Injury Study (RISCIS) Phase II/III trial (ClinicalTrials.gov Identifier: NCT01597518), a total of 32 SCI patients were enrolled, and most of our patients were middle-age Caucasian males with head and neck injuries. We studied the PK and pharmacodynamics (PD) of riluzole on motor recovery, measured by International Standards for Neurological Classification of SCI (ISNCSCI) Motor Score at injury and at 3-month and 6-month follow-ups, along with levels of the axonal injury biomarker phosphorylated neurofilament heavy chain (pNF-H), during the 2-week treatment. PK modeling, PK/PD correlations were developed to identify the potential effective exposure of riluzole for intended PD outcomes. The longitudinal impacts of SCI on the PK of riluzole are characterized. A time-varying population PK model of riluzole is established, incorporating time-varying clearance and volume of distribution from combined data of Phase I and Phase II/III trials. With the developed model, a rational, optimal dosing scheme can be designed with time-dependent modification to preserve the required therapeutic exposure of riluzole. The PD of riluzole and the relationship between PK and neurological outcomes of the treatment were established. The time course of efficacy in total motor score improvement (ΔTMS) and pNF-H were monitored. A three-dimensional (3D) PK/PD correlation was established for ΔTMS at 6 months with overall riluzole exposure area under the curve for Day 0-Day14 (AUCD0-D14) and baseline TMS for individual patients. Patients with baseline TMS between 1 and 36 benefited from the optimal exposure range of 16-48 mg*h/mL. The PD models of pNF-H revealed the riluzole efficacy, as treated subjects exhibited a diminished increase in progression of pNF-H, indicative of reduced axonal breakdown. The independent parameter of area between effective curves (ABEC) between the time profiles of pNF-H in placebo and treatment groups was statistically identified as a significant predictor for the treatment effect on the biomarker. A mechanistic clinical outcomes (CO)/PD (pNF-H) model was established, and the proposed structure demonstrated the feasibility of PK/PD/CO correlation model. No appreciable hepatic toxicity was observed with the current riluzole treatment regimen. The development of effective treatment for SCI is challenging. However, the future model-informed and PK-guided drug development and regimen modification can be rationally executed with the optimal dosing regimen design based on the developed 3D PK/PD model. The PK/PD/CO model can serve as a rational guide for future drug development, PKPD model refinement, and extension to other studies in SCI settings.


Subject(s)
Amyotrophic Lateral Sclerosis , Cervical Cord , Neck Injuries , Neuroprotective Agents , Spinal Cord Injuries , Male , Middle Aged , Humans , Riluzole/adverse effects , Neuroprotective Agents/adverse effects , Neuroprotective Agents/pharmacokinetics , Amyotrophic Lateral Sclerosis/drug therapy , Spinal Cord Injuries/drug therapy , Neck Injuries/drug therapy
15.
Neuromodulation ; 2023 May 04.
Article in English | MEDLINE | ID: mdl-37140522

ABSTRACT

STUDY DESIGN: This is a report of methods and tools for selection of task and individual configurations targeted for voluntary movement, standing, stepping, blood pressure stabilization, and facilitation of bladder storage and emptying using tonic-interleaved excitation of the lumbosacral spinal cord. OBJECTIVES: This study aimed to present strategies used for selection of stimulation parameters for various motor and autonomic functions. CONCLUSIONS: Tonic-interleaved functionally focused neuromodulation targets a myriad of consequences from spinal cord injury with surgical implantation of the epidural electrode at a single location. This approach indicates the sophistication of the human spinal cord circuitry and its important role in the regulation of motor and autonomic functions in humans.

16.
J Neurotrauma ; 40(23-24): 2621-2637, 2023 12.
Article in English | MEDLINE | ID: mdl-37221869

ABSTRACT

Abstract Individuals with SCI are severely affected by immune system changes, resulting in increased risk of infections and persistent systemic inflammation. While recent data support that immunological changes after SCI differ in the acute and chronic phases of living with SCI, only limited immunological phenotyping in humans is available. To characterize dynamic molecular and cellular immune phenotypes over the first year, we assess RNA (bulk-RNA sequencing), protein, and flow cytometry (FACS) profiles of blood samples from 12 individuals with SCI at 0-3 days and at 3, 6, and 12 months post injury (MPI) compared to 23 uninjured individuals (controls). We identified 967 differentially expressed (DE) genes in individuals with SCI (FDR <0.001) compared to controls. Within the first 6 MPI we detected a reduced expression of NK cell genes, consistent with reduced frequencies of CD56bright, CD56dim NK cells present at 12 MPI. Over 6MPI, we observed increased and prolonged expression of genes associated with inflammation (e.g. HMGB1, Toll-like receptor signaling) and expanded frequencies of monocytes acutely. Canonical T-cell related DE genes (e.g. FOXP3, TCF7, CD4) were upregulated during the first 6 MPI and increased frequencies of activated T cells at 3-12 MPI. Neurological injury severity was reflected in distinct whole blood gene expression profiles at any time after SCI, verifying a persistent 'neurogenic' imprint. Overall, 2876 DE genes emerge when comparing motor complete to motor incomplete SCI (ANOVA, FDR <0.05), including those related to neutrophils, inflammation, and infection. In summary, we identify a dynamic immunological phenotype in humans, including molecular and cellular changes which may provide potential targets to reduce inflammation, improve immunity, or serve as candidate biomarkers of injury severity.


Subject(s)
Spinal Cord Injuries , Humans , Spinal Cord Injuries/metabolism , Phenotype , Biomarkers , Transcriptome , Inflammation/metabolism
17.
Surg Neurol Int ; 14: 87, 2023.
Article in English | MEDLINE | ID: mdl-37025529

ABSTRACT

Background: Traumatic spinal cord injury (tSCI) is a debilitating condition, leading to chronic morbidity and mortality. In recent peer-reviewed studies, spinal cord epidural stimulation (scES) enabled voluntary movement and return of over-ground walking in a small number of patients with motor complete SCI. Using the most extensive case series (n = 25) for chronic SCI, the present report describes our motor and cardiovascular and functional outcomes, surgical and training complication rates, quality of life (QOL) improvements, and patient satisfaction results after scES. Methods: This prospective study occurred at the University of Louisville from 2009 to 2020. scES interventions began 2-3 weeks after surgical implantation of the scES device. Perioperative complications were recorded as well as long-term complications during training and device related events. QOL outcomes and patient satisfaction were evaluated using the impairment domains model and a global patient satisfaction scale, respectively. Results: Twenty-five patients (80% male, mean age of 30.9 ± 9.4 years) with chronic motor complete tSCI underwent scES using an epidural paddle electrode and internal pulse generator. The interval from SCI to scES implantation was 5.9 ± 3.4 years. Two participants (8%) developed infections, and three additional patients required washouts (12%). All participants achieved voluntary movement after implantation. A total of 17 research participants (85%) reported that the procedure either met (n = 9) or exceeded (n = 8) their expectations, and 100% would undergo the operation again. Conclusion: scES in this series was safe and achieved numerous benefits on motor and cardiovascular regulation and improved patient-reported QOL in multiple domains, with a high degree of patient satisfaction. The multiple previously unreported benefits beyond improvements in motor function render scES a promising option for improving QOL after motor complete SCI. Further studies may quantify these other benefits and clarify scES's role in SCI patients.

18.
World Neurosurg ; 175: e984-e993, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37087034

ABSTRACT

OBJECTIVES: The trend of practice pattern and impact on health care utilization for surgery and radiation therapy (RT) in patients with glomus jugulare tumors (GJTs) is not well defined. METHODS: The IBM (Armonk, NY) MarketScan database was queried using the ICD-9/10 and CPT 4th edition, 2000-2020. We included patients ≥18 years of age who underwent either surgery or RT with at-least 1-year follow-up. We compared the health care utilization at 3-month, 6-month, and 1-year follow up using the inverse probability of treatment weight technique. RESULTS: A cohort of 333 patients was identified. Of these, 72.7% (n = 242) underwent RT and 27.3% (n = 91) underwent surgery. RT use increased from 2002-2004 (50%) to 2017-2019 (91%). Patients in the surgery cohort were younger (median age 49 vs. 56 years, P < 0.0001) and had a higher 3+ comorbidity index (34% vs. 30%, P = 0.43) compared with patients in the RT cohort. Patients who underwent surgery had higher complications at index hospitalization (22% vs. 6%, P < 0.0001) and at 30 days (14% vs. 5%, P = 0.0042). No difference in combined index and 6- or 12-month payments were noted (6-months: surgery, $66m108, RT: $43m509, P = 0.1034; 12-months: surgery, $73,259, RT: $51,576, P = 0.1817). Only 4% of patients who had initial RT underwent RT and none underwent surgery at 12 months, whereas 6% of patients who had initial surgery underwent RT and 2% underwent surgery at 12 months. CONCLUSIONS: RT plays an increasingly important role in the treatment for patients with GJTs, with fewer complications and a comparable health care utilization at 1 year.


Subject(s)
Glomus Jugulare Tumor , Radiosurgery , Humans , Middle Aged , Glomus Jugulare Tumor/pathology , Retrospective Studies , Radiosurgery/methods , Patient Acceptance of Health Care , Treatment Outcome , Follow-Up Studies
19.
J Clin Neurosci ; 111: 86-90, 2023 May.
Article in English | MEDLINE | ID: mdl-36989768

ABSTRACT

BACKGROUND: Intraoperative magnetic resonance imaging (iMRI) use in transsphenoidal approach (TSA) for pituitary tumors (PTs) has been reported to improve the extent of resection (EOR). The aim of this study is to report the trends and the impact of iMRI on healthcare utilization in patients who underwent TSA for PTs. MATERIALS AND METHODS: MarketScan database were queried using the ICD-9/10 and CPT-4, from 2004 to 2020. We included patients ≥ 18 years of age PTs with > 1 year follow-up. Outcomes were length of stay (LOS), discharge disposition, hospital/emergency room (ER) re-admissions, outpatient services, medication refills and corresponding payments. RESULTS: A cohort of 10,192 patients were identified from the database, of these 141 patients (1.4%) had iMRI used during the procedure. Use of iMRI for PTs remained stable (2004-2007: 0.85%; 2008-2011: 1.6%; 2012-2015:1.4% and 2016-2019: 1.46%). No differences in LOS (median 3 days each), discharge to home (93% vs. 94%), complication rates (7% vs. 13%) and payments ($34604 vs. $33050) at index hospitalization were noted. Post-discharge payments were not significantly different without and with iMRI use at 6-months ($8315 vs. $ 7577, p = 0.7) and 1-year ($13,654 vs. $ 14,054, p = 0.70), following the index procedure. CONCLUSION: iMRI use during TSA for PTs remained stable with no impact on LOS, complications, discharge disposition and index payments. Also, there was no difference in combined index payments at 6-months, and 1-year after the index procedure in patients with and without iMRI use for PTs.


Subject(s)
Adenoma , Pituitary Neoplasms , Humans , Pituitary Neoplasms/diagnostic imaging , Pituitary Neoplasms/surgery , Pituitary Neoplasms/pathology , Aftercare , Adenoma/surgery , Patient Discharge , Magnetic Resonance Imaging/methods , Patient Acceptance of Health Care , Retrospective Studies
20.
Cureus ; 15(1): e34194, 2023 Jan.
Article in English | MEDLINE | ID: mdl-36843733

ABSTRACT

BACKGROUND: A variety of surgical approaches (anterior vs. posterior vs. anterior and posterior) are available for Isthmic Spondylolisthesis (IS). The aim of our study was to analyze the pattern and 30-day outcomes in patients undergoing different surgical approaches for single-level IS. MATERIALS AND METHODS: National Surgical Quality Improvement Program (NSQIP) database was queried using the ICD-9/10 and CPT 4th edition, from 2012 to 2020. We included patients 18-65 years of age who underwent spine fusions for IS. Outcomes were a length of stay (LOS), discharge disposition, 30-day complications, hospital readmission, and complication rates. RESULTS: Of 1036 patients who underwent spine fusions for IS, 838 patients (80.8%) underwent posterior only, 115 patients (11.1%) underwent anterior-only fusions and the rest (8%) underwent combined anterior and posterior procedures. 60% of patients in the posterior-only cohort had at least one comorbidity compared to 54% of patients in anterior only and 55% of patients in the combined cohort. No statistically significant differences in terms of LOS (3 days each) and discharge to home (96% vs. 93% vs. 94%) were noted among the anterior-only, posterior-only and combined cohorts, p> 0.05. In terms of 30-day complication rates, combined procedures had slightly higher rates (13%) compared to anterior (10%) or posterior-only (9%) procedures. CONCLUSION: Posterior-only fusions were performed in 80% of patients with IS. No differences in terms of LOS, discharge disposition to home, 30-day complications, hospital readmission and reoperation rates were noted across the cohorts.

SELECTION OF CITATIONS
SEARCH DETAIL
...