Application of non-invasive neuromodulation in children with neurodevelopmental disorders to improve their sleep quality and constipation.

BACKGROUND: Children with neurodevelopmental disorders have a very wide clinical variability. A common prevalent factor is problems with stool and sleep quality. Currently, there are multiple studies related to their evaluation, but not so much related to a specific intervention. The aim was to evaluate the effectiveness and safety of the application of non-invasive neuromodulation as a treatment in children with neurodevelopmental disorders to improve constipation and quality of sleep. METHODS: A total of 23 minors aged between 2 and 16 were included in this cross-sectional study. All participants were applied the microcurrent device for 60 min, 3 times per week for a total of 4 weeks. The technique was based on non-invasive neuromodulation using a surface-applied microcurrent electrostimulation device that administers an external, imperceptible, pulsed electrical stimulation. It is applied to the extremities, in a coordinated manner, using gloves and anklets connected with electrodes to a control console. Sleep latency and microarousals were evaluated through a sleep diary. To assess the evolution and type of defecation, the adapted and validated version in Spanish of the Bristol Stool Form Scale was used. RESULTS: No adverse events occurred during the study and no incidences were registered. Clinically relevant improvements were registered in defecation frequency and type as well as in sleep related parameters. An increase in the hours of sleep was registered, from 7,35 (0,83) to 9,09 (1,35), and sleep interruptions decreased from 3,83 (1,95) to 1,17 (1,11), (p < .001). CONCLUSION: Microcurrents can be used as an effective and safe treatment to improve quality of sleep and constipation in children with neurodevelopmental disorders. More studies are needed in order to obtain statistically significant results. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT05265702. FIRST REGISTRATION: 03/03/2022 PROTOCOL: https://clinicaltrials.gov/ct2/show/NCT05265702?term=baez+suarez&draw=2&rank=4.

Temporal Changes in Clinical Outcomes after Minimally Invasive Surgery for Hallux Valgus Correction in Women without Postoperative Complications.

Minimally invasive surgery (MIS) is currently used to correct hallux valgus deformities. Most studies reporting on MIS techniques to correct hallux valgus deformities included patients with postoperative complications. These reported complications, with an average rate of 23%, had significant negative effects on the clinical outcomes in this patient population. In the present study, a cohort of 63 women who underwent MIS hallux valgus correction was assessed preoperatively and at a mean follow-up of 1.0, 4.7, and 6.5 years using the American Orthopaedic Foot and Ankle Society (AOFAS) scale and the Manchester Oxford Foot Questionnaire (MOXFQ). The main criterion for inclusion in this cohort was a lack of complications during the entire follow-up period. The results showed significant improvements in both AOFAS and MOXFQ scores between the preoperative and 1-year follow-up assessments. By contrast, clinically small and nonsignificant changes were observed among postoperative follow-up values. The number of enrolled patients needs to be increased in future studies, with different surgeons and techniques included. Nevertheless, our study findings will inform patients about the outcomes they can expect over the years if no complications occur.

Medical Psychotropics in Forensic Autopsies in European Countries: Results from a Three-Year Retrospective Study in Spain.

Medical psychotropics are widely used and prescribed in developed countries. These medications may have an impairing effect on mood or perception and may induce harmful behaviors. Nevertheless, in Europe, studies on their importance from a medico-legal perspective are scarce. To fill this gap, we evaluate the determinants of these drugs in a retrospective study based on data obtained from forensic autopsies. Toxicological analyses were performed on 394 blood samples from compulsory autopsies at the Institute of Legal Medicine of Las Palmas. Of the samples, 41% (159) were positive for at least one psychotropic, with benzodiazepines being the most frequently detected (24.1%), followed by opiates and antidepressants. Benzodiazepines, opiates, and antidepressants were detected more frequently in men who suffered a violent death. More than 30% of the positive samples showed two or more drugs, suggesting a prevalence of polypharmacy among forensic autopsy subjects, with the most frequently combination found being benzodiazepines plus opiates (28.3% of positive samples). A combination of opiates plus antidepressants was also found in subjects involved in violent deaths. Our results suggest that more than 40% of the adult European population involved in medico-legal issues may be under the influence of legal psychotropics. The link between violent deaths and the use of medical psychotropics is particularly worrisome and indicates that these drugs should be carefully monitored in developed countries, in all forensic autopsies, in a similar way to illegal psychotropics.

Ethanol and Medical Psychotropics Co-Consumption in European Countries: Results from a Three-Year Retrospective Study of Forensic Samples in Spain.

Ethanol and medical psychotropics (MPs) are legal psychoactive substances widely consumed in Western countries that are routinely detected in standard toxicological analyses at compulsory autopsies, and toxicokinetic interactions between these drugs have been described. However, studies assessing the consequences of this co-consumption are scarce in Europe. We performed a retrospective study on toxicological results from compulsory autopsies in Spain. Thirty-five legal psychotropics, including ethanol, were measured in blood samples from 380 decedents to assess the determinants of such co-consumption. MPs were detected in 42.4% of the subjects. Polypharmacy was frequent in our series (25%), being more frequent in men than in women. More than one-third of the decedents had detectable levels of ethanol, and a significant positive association between ethanol levels and age was evident. About one-third of MPs consumers were also co-consumers of ethanol. The simultaneous consumption of ethanol and MPs was higher in men than in women. Blood alcohol concentrations (BAC) were lower in men who consumed MPs. In polypharmacy deaths, there was a significant negative association between the number of MPs consumed and BAC in men (r = -0.097; p = 0.029). Our results showed a high prevalence of co-consumption of MPs and ethanol in the European population involved in medico-legal issues and suggest that toxicokinetic interactions may be lowering BAC in men. This is a very worrying result, as it could indicate that the legal blood ethanol limits set by legislation would not be appropriate for men on MPs treatment.

Evaluation of different doses of transcutaneous nerve stimulation for pain relief during labour: a randomized controlled trial.

BACKGROUND: Pain during labour is one of the most intense pain that women may experience in their lifetime. There are several non-pharmacological analgesic methods to relieve pain during labour, among them transcutaneous electrical nerve stimulation (TENS). TENS is a low-frequency electrotherapy technique, analgesic type, generally used in musculoskeletal pathology, but it has also come to be used as an alternative treatment during labour. The purpose of this study is to investigate the pain-relieving effect of a TENS application during labour and to find out the most effective dose. METHODS: This study is a randomized, double-blind, placebo-controlled trial. TENS therapy was initiated at the beginning of the active phase of labour. Participants were randomly assigned to three groups (21 per group: two active TENS and one placebo). Active TENS 1 intervention consisted in a constant frequency of 100-Hz, 100-µs, active TENS 2 intervention consisted in a varying high-frequency (80-100 Hz), 350 µs, and in a placebo group, participants were connected to the TENS unit without electrical stimulation. TENS was applied with two self-adhesive electrodes placed parallel to the spinal cord (T10-L1 and S2-S4 levels). The primary outcome was pain intensity (0-10 cm) measured on a visual analogue scale (VAS) at several stages (at baseline and at 10 and 30 min later). Secondary outcomes included women's satisfaction (via the Care in Obstetrics: Measure for Testing Satisfaction scale). RESULTS: Sixty-three women participated. Regarding baseline characteristics, no differences were found among the three groups. The active TENS 2 group obtained an improvement with clinically significant VAS results (- 2.9, 95% confidence interval - 4.1 to - 1.6, p <  0.001). Regarding satisfaction, the results also revealed better results in the active TENS than in the placebo group. CONCLUSIONS: TENS with high frequencies modified in time as well as high pulse width are effective for relieving labour pain, and they are well considered by pregnant participants. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03137251 . Registered on 2 May 2017.

Mindfulness in the Maintenance of Cognitive Capacities in Alzheimer's Disease: A Randomized Clinical Trial.

BACKGROUND: The Canary Islands longitudinal study on non-pharmacological treatments showed the overall effectiveness of mindfulness in Alzheimer's disease (AD). However, no specific data on the maintenance of cognitive capacities were presented. OBJECTIVE: To determine whether the practice of mindfulness modifies the course of cognitive impairment in AD. DESIGN: Longitudinal, non-inferiority and equivalence, randomized clinical trial, repeated-measures design, with three experimental groups and one control group. PARTICIPANTS: Patients with AD who voluntarily attended the Lidia García Foundation (n = 502). Only those who were treated with donepezil and MMSE ≥18 were included (n = 120). INTERVENTION: Over a two-year period, each group carried out three weekly sessions of stimulation based on mindfulness, cognitive stimulation therapy, and progressive muscle relaxation. MEASURES: Cognitive assessment CAMDEX-R (MMSE and CAMCOG). STATISTICAL ANALYSIS: Repeated-measures ANOVA (p <  0.05) and the effect size Cohen's d were performed. RESULTS: The mindfulness group showed significant scores compared with the control and muscle relaxation groups (p <  0.05), while mindfulness and cognitive stimulation therapy were equivalent (p≥0.05). Group cognitive stimulation evolved better than the control (p <  0.05) group but not better than the muscle relaxation group (p≥0.05). The effect size compared over two years was large for the mindfulness group (p≥0.80), moderate for the relaxation group (p≥0.50), and low for the cognitive stimulation group (p≥0.20). CONCLUSION: The practice of mindfulness maintained cognitive function over a period of two years. This longitudinal study suggests that mindfulness can be used as a non-pharmacological treatment to slow cognitive impairment in AD.