Development and pilot administration of the amputation-related pain and sensation assessment tool.

PURPOSE: To develop and administer an assessment tool for facilitating patient-clinician discussions regarding amputation-related pain and sensation. MATERIALS AND METHODS: An assessment tool was developed to measure the impact of different types of amputation-related pain and sensation on a patient's life. The tool first provides patients with written descriptions and images of three common types of amputation-related pain or sensations: residual limb pain, phantom limb sensation, and phantom limb pain. The tool then asks them to rate the frequency, intensity, and interference of each experience. Participants were also asked to provide qualitative descriptions of these experiences. RESULTS: Fifty Veterans with lower limb amputation participated in the study. In the past month, 74% reported experiencing residual limb pain, 76% reported phantom limb sensation, and 84% reported phantom limb pain, with 52% reporting all three. Participants' descriptions of some experiences were distinct, while others (e.g., "tingling") were common between experiences. Phantom limb pain had the most varied descriptions. CONCLUSIONS: The amputation-related pain and sensation assessment tool can be used to identify and measure the effects of different experiences on patients' lives, thereby improving the specificity of diagnosis and informing clinical treatment recommendations. Further development of this tool should include evaluating its psychometric properties.

The amputation-related pain and sensation assessment tool was developed for use in patient­clinician discussions to identify and measure residual limb pain, phantom limb sensation, and phantom limb pain.In our sample, participants used common words to describe all three experiences.The use of illustrations in combination with descriptions may aid in differentiating these distinct experiences.Next steps for this assessment tool include further development of illustrations to represent patient diversity as well as evaluation of psychometric properties.

Graded motor imagery and its phases for individuals with phantom limb pain following amputation: A scoping review.

OBJECTIVE: Three-phase graded motor imagery (limb laterality, explicit motor imagery, and mirror therapy) has been successful in chronic pain populations. However, when applied to phantom limb pain, an amputation-related pain, investigations often use mirror therapy alone. We aimed to explore evidence for graded motor imagery and its phases to treat phantom limb pain. DATA SOURCES: A scoping review was conducted following the JBI Manual of Synthesis and Preferred Reporting Items for Systematic Review and Meta-Analyses extension for Scoping Reviews. Thirteen databases, registers, and websites were searched. REVIEW METHODS: Published works on any date prior to the search (August 2023) were included that involved one or more graded motor imagery phases for participants ages 18+ with amputation and phantom limb pain. Extracted data included study characteristics, participant demographics, treatment characteristics, and outcomes. RESULTS: Sixty-one works were included representing 19 countries. Most were uncontrolled studies (31%). Many participants were male (75%) and had unilateral amputations (90%) of varying levels, causes, and duration. Most works examined one treatment phase (92%), most often mirror therapy (84%). Few works (3%) reported three-phase intervention. Dosing was inconsistent across studies. The most measured outcome was pain intensity (95%). CONCLUSION: Despite the success of three-phase graded motor imagery in other pain populations, phantom limb pain research focuses on mirror therapy, largely ignoring other phases. Participant demographics varied, making comparisons difficult. Future work should evaluate graded motor imagery effects and indicators of patient success. The represented countries indicate that graded motor imagery phases are implemented internationally, so future work could have a widespread impact.

Clinician perspectives on postamputation pain assessment and rehabilitation interventions.

OBJECTIVE: The purpose of this study was to explore self-reported Veterans Affairs (VA) amputation clinician perspectives and clinical practices regarding the measurement and treatment for amputation-related pain. STUDY DESIGN: Cross-sectional survey with 73 VA rehabilitation clinicians within the VA Health Care System. RESULTS: The most frequent clinical backgrounds of respondents included physical therapists (36%), prosthetists (32%), and physical medicine and rehabilitation specialist (21%). Forty-one clinicians (56%) reported using pain outcome measures with a preference for average pain intensity numeric rating scale (generic) (97%), average phantom limb pain intensity numeric rating scale (80%), or Patient-Reported Outcomes Measurement Information System pain interference (12%) measures. Clinicians' most frequently recommended interventions were compression garments, desensitization, and physical therapy. Clinicians identified mindset, cognition, and motivation as factors that facilitate a patient's response to treatments. Conversely, clinicians identified poor adherence, lack of belief in interventions, and preference for traditional pain interventions (e.g., medications) as common barriers to improvement. We asked about the frequently used treatment of graded motor imagery. Although graded motor imagery was originally developed with 3 phases (limb laterality, explicit motor imagery, mirror therapy), clinicians reported primarily using explicit motor imagery and mirror therapy. RESULTS: Most clinicians who use standardized pain measures prefer intensity ratings. Clinicians select pain interventions based on the patient's presentation. This work contributes to the understanding of factors influencing clinicians' treatment selection for nondrug interventions. Future work that includes qualitative components could further discern implementation barriers to amputation pain rehabilitation interventions for greater consistency in practice.

Virtual Reality Game Selection for Traumatic Brain Injury Rehabilitation: A Therapist's Wish List for Game Developers.

This project explored the selection process of commercially available virtual reality (VR) games for traumatic brain injury rehabilitation. Occupational therapy practitioners (OTPs) developed a classification framework that they used to evaluate VR games. The classification framework focused on movements required to effectively play the game, cognitive demand, position for game play, ease in menu navigation, and perceived therapeutic applications. OTPs used the ratings to aid in game selection and identified relevant game examples that allowed customizable settings and basic navigation with a game focus on functional activities. The OTPs and the research team identified the need for further work on accessibility and adaptability of game features (e.g., difficulty and limb usage) allowing for more individualization to optimize outcomes of VR-enhanced rehabilitation. The classification framework was useful in evaluating the potential therapeutic benefit of commercially available VR games. However, trial of the game by clinicians prior to use was still warranted.

Veteran Perspectives on Phantom Limb Pain and Non-Drug Interventions.

Background: Phantom limb pain (PLP) commonly occurs post-amputation and can negatively affect the daily functioning of persons with amputation. Best practices for medication and non-drug management remain unclear. Objective: To better understand the PLP experience and patients' familiarity with treatments, phone interviews were conducted at the Minneapolis Veterans Affairs Regional Amputation Center in Veterans with amputations. Methods: Fifty Veteran participants (average age 66, 96% male) with lower limb amputation were recruited for phone-based data collection of patient-reported outcomes (ie, demographics using the Trinity Amputation and Prosthesis Experience Scales-Revised (TAPES-R) and pain experience using the Phantom Phenomena Questionnaire) to characterize the population and a semi-structured interview. Notes taken during interviews were analyzed using the Krueger and Casey constant comparison analysis method. Results: Participants had an average of 15 years since amputation, and 80% reported PLP as identified with the Phantom Phenomena Questionnaire. Investigators identified several core themes from the qualitative interviews including 1) high variability in the experience of PLP, 2) acceptance and resilience, and 3) PLP treatment perceptions. The majority of participants reported trying common non-drug treatments with none endorsed consistently as highly effective. Conclusion: More research is needed to inform identification and implementation of clinical best practices for non-drug interventions for PLP and understand the factors that influence engagement in non-drug interventions. The participants in this study were largely male, so these results may not be generalizable to females.

Feasibility testing of a novel prosthetic socket sensor system.

PURPOSE: Poorly fitting prosthetic sockets contribute to decreased quality of life, health, and well-being for persons with amputations. Therefore, improved socket fit is a high clinical priority. METHODS: In this study, we describe the design and testing of a novel sensor system that can be incorporated into a prosthetic socket to measure distal end weight bearing in the socket and can alert a prosthesis user if poor socket fit is suspected. We present the results of testing this device with three Veterans who were new prosthesis users and three Veterans who were experienced prosthesis users. RESULTS AND CONCLUSIONS: We collected sensor data during walking trials while participants wore varying numbers of sock plies and qualitative feedback on the design of the socket fit sensor system. For analysis, peak sensor measurements during walking cycles were identified and combined with socket fit data (i.e., a clinician-determined level of "good," "too tight," or "too loose" and the number of sock ply worn each trial). We found consistent relationships between peak sensor measurements and socket fit in our sample. Also, all users expressed an interest in the device, highlighting its potential benefits during early prosthesis training.Implications for RehabilitationEnsuring socket fit is challenging for many prosthesis users.A novel wearable sensor system can be used to identify socket fit issues for some prosthesis users.This type of system could be most helpful for new prosthesis users and those with sensory and cognitive challenges.

Strategies for graded motor imagery for clients with phantom limb pain and cognitive impairment.

BACKGROUND: Individuals with amputations often experience phantom limb pain (PLP) that can limit their participation in rehabilitation, prosthesis training, desired activities, and roles. One nonpharmacological rehabilitation intervention for PLP is graded motor imagery (GMI). There are several components to GMI, including right/left discrimination or laterality, motor imagery, sensory retraining, and mirror therapy. Successful implementation of GMI requires a range of cognitive skills, such as attention span, working memory, abstract reasoning, and planning. For individuals with PLP who concurrently display cognitive impairments, GMI protocols can be adapted using strategies derived from clinical practice. OBJECTIVES: The purpose of this technical clinical report was to discuss the application of clinically implemented cognitive compensation techniques to GMI instruction. STUDY DESIGN: Not applicable. METHODS: Clinical expert opinion to explore adaptations for GMI. TECHNIQUE: Graded motor imagery can be an effective tool for pain treatment; however, some clients may need greater clinician support due to existing cognitive difficulties. RESULTS: For clients to be successful, active engagement in learning about and implementing GMI techniques is necessary. CONCLUSIONS: When serving the lifetime amputation care needs of patients with cognitive deficits, we find that targeted learning strategies and accommodations can be helpful when introducing GMI concepts and skill development. Enhanced patient education techniques support client learning.

Ipsilateral Corticospinal Tract Excitability Contributes to the Severity of Mirror Movements in Unilateral Cerebral Palsy: A Case Series.

Mirror movements (MM) can be a clinical manifestation of unilateral cerebral palsy (UCP) causing involuntary movements when attempting to use either hand for functional activities. Atypical development of the corticospinal tract (CST) contributes to impairments in observed motor movements and functional activities. However, little is known about the underlying neurophysiology and contribution of the CST to MM. The current case study characterizes MM in 13 children and young adults with UCP ranging in age from 7 to 19 years and includes clinical and neurophysiologic variables. Clinical profiles included MM of each hand (ie, Woods and Teuber), bimanual coordination and hand use (Assisting Hand Assessment [AHA]), and perception of performance (Canadian Occupational Performance Measure [COPM]). We measured the strength of motor-evoked potentials (MEP) elicited from single-pulse transcranial magnetic stimulation (TMS) of each hemisphere to create a ratio of hemispheric responses. Our sample included three types of CST circuitry: ipsilateral (n = 5), bilateral (n = 3), and contralateral (n = 4). The MEP ratio ranged from 0 to 1.45 (median 0.11) with greater MM observed in participants with ratios greater than 0.5. We observed a positive relationship between the MEP ratio and the more-affected MM score, meaning participants with larger ipsilateral responses from contralesional stimulation (eg, the contralesional hemisphere was stimulated with TMS resulting in an ipsilateral MEP response), as compared with contralateral responses, displayed greater MM than those that did not. There was no relationship between MM and function as measured by the AHA or COPM. These findings suggest a role of the contralesional hemisphere to MM, which could serve as a therapeutic target for interventions.

Influence of Combined Transcranial Direct Current Stimulation and Motor Training on Corticospinal Excitability in Children With Unilateral Cerebral Palsy.

Combined non-invasive brain stimulation (NIBS) and rehabilitation interventions have the potential to improve function in children with unilateral cerebral palsy (UCP), however their effects on developing brain function are not well understood. In a proof-of-principle study, we used single-pulse transcranial magnetic stimulation (TMS) to measure changes in corticospinal excitability and relationships to motor performance following a randomized controlled trial consisting of 10 days of combined constraint-induced movement therapy (CIMT) and cathodal transcranial direct current stimulation (tDCS) applied to the contralesional motor cortex. Twenty children and young adults (mean age = 12 years, 9 months, range = 7 years, 7 months, 21 years, 7 months) with UCP participated. TMS testing was performed before, after, and 6 months after the intervention to measure motor evoked potential (MEP) amplitude and cortical silent period (CSP) duration. The association between neurophysiologic and motor outcomes and differences in excitability between hemispheres were examined. Contralesional MEP amplitude decreased as hypothesized in five of five participants receiving active tDCS immediately after and 6 months after the intervention, however no statistically significant differences between intervention groups were noted for MEP amplitude [mean difference = -323.9 µV, 95% CI = (-989, 341), p = 0.34] or CSP duration [mean difference = 3.9 ms, 95% CI = (-7.7, 15.5), p = 0.51]. Changes in corticospinal excitability were not statistically associated with improvements in hand function after the intervention. Across all participants, MEP amplitudes measured in the more-affected hand from both contralesional (mean difference = -474.5 µV) and ipsilesional hemispheres (-624.5 µV) were smaller compared to the less-affected hand. Assessing neurophysiologic changes after tDCS in children with UCP provides an understanding of long-term effects on brain excitability to help determine its potential as a therapeutic intervention. Additional investigation into the neurophysiologic effects of tDCS in larger samples of children with UCP are needed to confirm these findings.

Bimanual Skill Learning after Transcranial Direct Current Stimulation in Children with Unilateral Cerebral Palsy: A Brief Report.

Bimanual skills are important for goal-oriented activities. Children with unilateral cerebral palsy (UCP) have deficits in unimanual and bimanual motor control and learning. The application of non-invasive brain stimulation with existing motor training may further promote motor learning; however, the effects of stimulation on bimanual learning have not been examined. Here, we assessed the performance of a novel bimanual skill (modified Speed Stacks task) in eight children with UCP before, during, and after a combined motor training and brain stimulation intervention. Participants received 10 days (120 min/day) of goal-oriented bimanual therapy combined initially with transcranial direct current stimulation (tDCS, 20 min/day). Results showed task improvement tapered (p < 0.001) during and after the intervention and task variability decreased in 6/8 participants, indicating the potential impact of novel rehabilitation to improve skill learning in children with UCP. Future work is required to understand how both tDCS and bimanual training contribute to learning bimanual tasks.

Electrode Placement in Transcranial Direct Current Stimulation-How Reliable Is the Determination of C3/C4?

The 10/20 electroencephalogram (EEG) measurements system often guides electrode placement for transcranial direct current stimulation (tDCS), a form of non-invasive brain stimulation. One targeted region of the brain is the primary motor cortex (M1) for motor recovery after stroke, among other clinical indications. M1 is identified by C3 and C4 of the 10/20 EEG system yet the reliability of 10/20 EEG measurements by novice research raters is unknown. We investigated the reliability of the 10/20 EEG measurements for C3 and C4 in 25 adult participants. Two novice raters were assessed for inter-rater reliability. Both raters received two hours of instruction from a registered neurodiagnostic technician. One of the raters completed the measurements across two testing days for intra-rater reliability. Relative reliability was determined using the intraclass coefficient (ICC) and absolute reliability. We observed a low to fair inter and intra-rater ICC for motor cortex measurements. The absolute reliability was <1.0 cm by different novice raters and on different days. Although a low error was observed, consideration of the integrity of the targeted region of the brain is critical when designing tDCS interventions in clinical populations who may have compromised brain structure, due to a lesion or altered anatomy.

Non-Invasive Brain Stimulation in Children With Unilateral Cerebral Palsy: A Protocol and Risk Mitigation Guide.

Non-invasive brain stimulation has been increasingly investigated, mainly in adults, with the aims of influencing motor recovery after stroke. However, a consensus on safety and optimal study design has not been established in pediatrics. The low incidence of reported major adverse events in adults with and without clinical conditions has expedited the exploration of NIBS in children with paralleled purposes to influence motor skill development after neurological injury. Considering developmental variability in children, with or without a neurologic diagnosis, adult dosing and protocols may not be appropriate. The purpose of this paper is to present recommendations and tools for the prevention and mitigation of adverse events (AEs) during NIBS in children with unilateral cerebral palsy (UCP). Our recommendations provide a framework for pediatric NIBS study design. The key components of this report on NIBS AEs are (a) a summary of related literature to provide the background evidence and (b) tools for anticipating and managing AEs from four international pediatric laboratories. These recommendations provide a preliminary guide for the assessment of safety and risk mitigation of NIBS in children with UCP. Consistent reporting of safety, feasibility, and tolerability will refine NIBS practice guidelines contributing to future clinical translations of NIBS.

Reference values of intrinsic muscle strength of the hand of adolescents and young adults.

STUDY DESIGN: A cross-sectional clinical measurement study. INTRODUCTION: Measuring intrinsic hand muscle strength helps evaluate hand function or therapeutic outcomes. However, there are no established normative values in adolescents and young adults between 13 and 20 years of age. PURPOSE OF THE STUDY: To measure hand intrinsic muscle strength and identify associated factors that may influence such in adolescents and young adults through use of the Rotterdam intrinsic hand myometer. METHODS: A total of 131 participants (male: 63; female: 68) between 13 and 20 years of age completed the strength measurements of abductor pollicis brevis, first dorsal interosseus (FDI), deep head of FDI and lumbrical of second digit, flexor pollicis brevis (FPB), and abductor digiti minimi. Two trials of the measurements of each muscle were averaged for analyses. Self-reported demographic data were used to examine the influences of age, sex, and body mass index (BMI) on intrinsic hand muscle strength. RESULTS: Normative values of intrinsic hand muscle strength were presented by age groups (13, 14, 15-16, 17-18, 19-20 year olds) for each sex category (male, female). A main effect of sex, but not age, on all the muscles on both the dominant (FPB: P = .02, others: P < .001) and non-dominant (FDI: P = .005, FPB: P = .01, others: P < .001) sides was found. A significant effect of BMI was found on dominant (P = .009) and non-dominant abductor pollicis brevis (P = .002). In addition, FDI (P = .005) and FPB (P = .002) were stronger on the dominant side than the non-dominant side. DISCUSSION: Intrinsic hand muscle strength may be influenced by different factors including sex, BMI, and hand dominance. A larger sample is needed to rigorously investigate the influence of age on intrinsic strength in male and female adolescents and young adults. CONCLUSION: The results provide reference values and suggest factors to be considered when evaluating hand function and therapeutic outcomes in both clinical and research settings. Further study is recommended. LEVEL OF EVIDENCE: VI.

Transcranial Direct Current Stimulation (tDCS) Paired with Occupation-Centered Bimanual Training in Children with Unilateral Cerebral Palsy: A Preliminary Study.

Objective: We investigated the preliminary efficacy of cathodal transcranial direct current stimulation (tDCS) combined with bimanual training in children and young adults with unilateral cerebral palsy based on the principle of exaggerated interhemispheric inhibition (IHI). Methods: Eight participants with corticospinal tract (CST) connectivity from the lesioned hemisphere participated in an open-label study of 10 sessions of cathodal tDCS to the nonlesioned hemisphere (20 minutes) concurrently with bimanual, goal-directed training (120 minutes). We measured the frequency of adverse events and intervention efficacy with performance (bimanual-Assisting Hand Assessment (AHA)-and unimanual-Box and Blocks), self-report (Canadian Occupational Performance Measure (COPM), ABILHAND), and neurophysiologic (motor-evoked potential amplitude, cortical silent period (CSP) duration, and motor mapping) assessments. Results: All participants completed the study with no serious adverse events. Three of 8 participants showed gains on the AHA, and 4 of 8 participants showed gains in Box and Blocks (more affected hand). Nonlesioned CSP duration decreased in 6 of 6 participants with analyzable data. Cortical representation of the first dorsal interosseous expanded in the nonlesioned hemisphere in 4 of 6 participants and decreased in the lesioned hemisphere in 3 of 4 participants with analyzable data. Conclusions: While goal achievement was observed, objective measures of hand function showed inconsistent gains. Neurophysiologic data suggests nonlinear responses to cathodal stimulation of the nonlesioned hemisphere. Future studies examining the contributions of activity-dependent competition and cortical excitability imbalances are indicated.

Less-Affected Hand Function in Children With Hemiparetic Unilateral Cerebral Palsy: A Comparison Study With Typically Developing Peers.

BACKGROUND: Neurorehabilitation interventions in children with unilateral cerebral palsy (UCP) target motor abilities in daily life yet deficits in hand skills persist. Limitations in the less-affected hand may affect overall bimanual hand skills. OBJECTIVE: To compare hand function, by timed motor performance on the Jebsen-Taylor Test of Hand Function (JTTHF) and grip strength of children with UCP to children with typical development (CTD), aged 8 to 18 years old. Exploratory analyses compared hand function measures with regard to neurophysiological outcomes measured by transcranial magnetic stimulation and between group comparisons of hemispheric motor threshold. METHODS: Baseline hand skills were evaluated in 47 children (21 UCP; 26 CTD). Single-pulse transcranial magnetic stimulation testing assessed corticospinal tract and motor threshold. RESULTS: The mean difference of the less-affected hand of children with UCP to the dominant hand of CTD on the JTTHF was 21.4 seconds (95% CI = 9.32-33.46, P = .001). The mean difference in grip strength was -30.8 N (95% CI = -61.9 to 0.31, P = .052). Resting motor thresholds between groups were not significant, but age was significantly associated with resting motor threshold ( P < .001; P = .001). Children with UCP ipsilateral pattern of motor representation demonstrated greater mean differences between hands than children with contralateral pattern of motor representation ( P < .001). All results were adjusted for age and sex. CONCLUSIONS: The less-affected hand in children with UCP underperformed the dominant hand of CTD. Limitations were greater in children with UCP ipsilateral motor pattern. Rehabilitation in the less-affected hand may be warranted. Bilateral hand function in future studies may help identify the optimal rehabilitation and neuromodulatory intervention.

Determining Electrode Placement for Transcranial Direct Current Stimulation: A Comparison of EEG- Versus TMS-Guided Methods.

Transcranial direct current stimulation (tDCS) is increasingly researched as an adjuvant to motor rehabilitation for children with hemiparesis. The optimal method for the primary motor cortex (M1) somatotopic localization for tDCS electrode placement has not been established. The objective, therefore, was to determine the location of the M1 derived using the 10/20 electroencephalography (EEG) system and transcranial magnetic stimulation (TMS) in children with hemiparesis (CWH) and a comparison group of typically developing children (TDC). We hypothesized a difference in location for CWH but not for TDC. The 2 locations were evaluated in 47 children (21 CWH, 26 TDC). Distances between the locations were measured pending presence of a motor evoked potential. Distances between the EEG and TMS locations that exceeded the 2.5 cm × 2.5 cm rubber electrode area are reported in percentages [95% confidence interval] in CWH-nonlesioned hemisphere was 68.8% [41.3-89.0], lesioned: 85.7% [57.2-98.2]; TDC-dominant hemisphere 73.9% [51.6-89.8], nondominant: 82.6% [61.2-95.0]. Distances that exceeded the 3 × 5 cm electrode sponge area in CWH-nonlesioned was 25.0% [7.3-52.4], lesioned was 28.6% [8.4-58.1]; TDC-dominant was 52.2% [30.6-73.2], nondominant was 43.5 [23.2-65.5]). Distances that exceeded the 5 × 7 cm electrode sponge area in CWH-nonlesioned was 18.8% [4.0-45.6] and lesioned was 21.4% [4.7-50.8]; TDC-dominant was 21.7% [7.5-43.7] and nondominant was 26.1% [10.2-48.4]. Individual variability in brain somatotopic organization may influence surface scalp localization of underlying M1 in children regardless of neurologic impairment. Findings suggest further investigation of optimal tDCS electrode placement. EEG and TMS methods reveal variability in localizing M1 in children regardless of stroke diagnosis. This study was registered on clinicaltrials.gov NCT02015338.

Corticospinal Excitability in Children with Congenital Hemiparesis.

Transcranial magnetic stimulation (TMS) can be used as an assessment or intervention to evaluate or influence brain activity in children with hemiparetic cerebral palsy (CP) commonly caused by perinatal stroke. This communication report analyzed data from two clinical trials using TMS to assess corticospinal excitability in children and young adults with hemiparetic CP. The results of this communication revealed a higher probability of finding a motor evoked potential (MEP) on the non-lesioned hemisphere compared to the lesioned hemisphere (p = 0.005). The resting motor threshold (RMT) was lower on the non-lesioned hemisphere than the lesioned hemisphere (p = 0.013). There was a significantly negative correlation between age and RMT (rs = -0.65, p = 0.003). This communication provides information regarding MEP responses, motor thresholds (MTs) and the association with age during TMS assessment in children with hemiparetic CP. Such findings contribute to the development of future pediatric studies in neuroplasticity and neuromodulation to influence motor function and recovery after perinatal stroke.

Repetitive Transcranial Magnetic Stimulation/Behavioral Intervention Clinical Trial: Long-Term Follow-Up of Outcomes in Congenital Hemiparesis.

OBJECTIVE: The purpose of this study was to examine long-term outcomes of nonpharmacological intervention in children and adolescents with stroke utilizing repetitive transcranial magnetic stimulation (rTMS) to the primary motor cortex combined with constraint- induced movement therapy (CIMT) to improve motor function in the paretic hand. Outcome measures included function, satisfaction, and medical status review. METHODS: Fourteen of the original 19 participants (74%) from our rTMS/CIMT clinical trial (real rTMS+CIMT, n = 8; and sham rTMS+CIMT, n = 6) were evaluated. The median age of the subjects at follow up was 13.4 years (range 11-20 years old, 50% male). Median time to follow-up was 47.5 months (range 21-57 months). Descriptive statistics were conducted using frequencies and counts. Motor performance was measured using the Assisting Hand Assessment (AHA) and Canadian Occupational Performance Measure (COPM). Satisfaction was reported with use of the COPM and TMS Tolerance Survey. Open-ended interview was conducted for feedback on study experience and subjective perspectives of current functional status. RESULTS: Overall, seven of eight individuals who received real rTMS and five of six individuals who received sham rTMS maintained or improved AHA scores. Six of 14 participants reported new onset of co-occurring conditions (four individuals in the real rTMS group, two individuals in the sham rTMS group). The majority (86%) of participants reported study satisfaction. Review of medical status revealed co-occurring conditions including: Epilepsy, obsessive-compulsive disorder, anxiety, depression, unspecified mood disorder, and undiagnosed inattentiveness. CONCLUSIONS: Long-term outcomes of rTMS/CIMT in pediatric stroke were investigated. Variability in performance and unattributed symptoms were noted. Considering the prevalence of co-occurring conditions in children and adolescents with stroke, new-onset symptoms were not attributed to original intervention. With the small sample size, the impact of rTMS on long-term outcomes cannot be fully determined from these data. Characterizing long-term outcomes through performance, participant perspectives, and medical status allows comprehensive assessment of rTMS/CIMT intervention efficacy.

Safety of primed repetitive transcranial magnetic stimulation and modified constraint-induced movement therapy in a randomized controlled trial in pediatric hemiparesis.

OBJECTIVE: To investigate the safety of combining a 6-Hz primed low-frequency repetitive transcranial magnetic stimulation (rTMS) intervention in the contralesional hemisphere with a modified constraint-induced movement therapy (mCIMT) program in children with congenital hemiparesis. DESIGN: Phase 1 randomized, double-blinded, placebo-controlled pretest/posttest trial. SETTING: University academic facility and pediatric specialty hospital. PARTICIPANTS: Subjects (N = 19; age range, 8-17 y) with congenital hemiparesis caused by ischemic stroke or periventricular leukomalacia. No subject withdrew because of adverse events. All subjects included completed the study. INTERVENTIONS: Subjects were randomized to 1 of 2 groups: either real rTMS plus mCIMT (n = 10) or sham rTMS plus mCIMT (n = 9). MAIN OUTCOME MEASURES: Adverse events, physician assessment, ipsilateral hand function, stereognosis, cognitive function, subject report of symptoms assessment, and subject questionnaire. RESULTS: No major adverse events occurred. Minor adverse events were found in both groups. The most common events were headaches (real: 50%, sham: 89%; P = .14) and cast irritation (real: 30%, sham: 44%; P = .65). No differences between groups in secondary cognitive and unaffected hand motor measures were found. CONCLUSIONS: Primed rTMS can be used safely with mCIMT in congenital hemiparesis. We provide new information on the use of rTMS in combination with mCIMT in children. These findings could be useful in research and future clinical applications in advancing function in congenital hemiparesis.