Electric Field Navigated 1-Hz rTMS for Poststroke Motor Recovery: The E-FIT Randomized Controlled Trial.

BACKGROUND: To determine if low-frequency repetitive transcranial magnetic stimulation targeting the primary motor cortex contralateral (M1CL) to the affected corticospinal tract in patients with hemiparetic stroke augments intensive training-related clinical improvement; an extension of the NICHE trial (Navigated Inhibitory rTMS to Contralesional Hemisphere Trial) using an alternative sham coil. METHODS: The present E-FIT trial (Electric Field Navigated 1Hz rTMS for Post-stroke Motor Recovery Trial) included 5 of 12 NICHE trial outpatient US rehabilitation centers. The stimulation protocol remained identical (1 Hz repetitive transcranial magnetic stimulation, M1CL, preceding 60-minute therapy, 18 sessions/6 wks; parallel arm randomized clinical trial). The sham coil appearance mimicked the active coil but without the weak electric field in the NICHE trial sham coil. Outcomes measured 1 week, and 1, 3, and 6 months after the end of treatment included the following: upper extremity Fugl-Meyer (primary, 6 months after end of treatment), Action Research Arm Test, National Institutes of Health Stroke Scale, quality of life (EQ-5D), and safety. RESULTS: Of 60 participants randomized, 58 completed treatment and were included for analysis. Bayesian analysis of combined data from the E-FIT and the NICHE trials indicated that active treatment was not superior to sham at the primary end point (posterior mean odds ratio of 1.94 [96% credible interval of 0.61-4.80]). For the E-FIT intent-to-treat population, upper extremity Fugl-Meyer improvement ≥5 pts occurred in 60% (18/30) active group and 50% (14/28) sham group. Participants enrolled 3 to 6 months following stroke had a 67% (31%-91% CI) response rate in the active group at the 6-month end point versus 50% in the sham group (21.5%-78.5% CI). There were significant improvements from baseline to 6 months for both active and sham groups in upper extremity Fugl-Meyer, Action Research Arm Test, and EQ-5D (P<0.05). Improvement in National Institutes of Health Stroke Scale was observed only in the active group (P=0.004). Ten serious unrelated adverse events occurred (4 active group, 6 sham group, P=0.72). CONCLUSIONS: Intensive motor rehabilitation 3 to 12 months after stroke improved clinical impairment, function, and quality of life; however, 1 Hz-repetitive transcranial magnetic stimulation was not an effective treatment adjuvant in the present sample population with mixed lesion location and extent. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03010462.

Association of Proportional Recovery After Stroke With Health-Related Quality of Life.

Background and Purpose: No data exists on whether proportional recovery (PR) is associated with health-related quality of life (HRQOL) domains. We evaluated whether PR was associated with domain-specific HRQOL scores at 3 months after ischemic stroke. Methods: This prospective cohort study enrolled patients with ischemic stroke between January 2017 and June 2018. Impaired strength was assessed using the Fugl-Meyer Upper Extremity (range, 0­66 points) and Motricity Index (range, 0­100 points) during index hospitalization and 3 months. Both measures are well-validated and reliable in patients with stroke to assesses motor functioning. PR (defined as 70% of difference between initial score and maximum possible recovery) was calculated from the initial measurements. HRQOL was measured using Neuro-QOL domains: upper extremity, depression, and cognition domains. PR was evaluated with HRQOL domains using binomial logistic regression. Results: Final analysis included 84 patients (mean age 67.8±16.4 years; 44% male; 51.2% White). For both Fugl-Meyer Upper Extremity and Motricity Index, the PR threshold was met for 48.8% of patients. Failure to meet Motricity Index PR was only associated with increased odds of HRQOL depression impairment (adjusted odds ratio, 11.8 [95% CI, 1.23­112.7]). Failure to meet Fugl-Meyer Upper Extremity PR threshold was not associated with HRQOL impairment after adjustment. Conclusions: Our findings suggest that reaching the PR threshold provides poor discrimination of HRQOL. Despite not meeting expected PR thresholds, patients can still maintain un-impaired HRQOL, suggesting other factors play a role in preserved HRQOL.

Clinical Performance Measures for Stroke Rehabilitation: Performance Measures From the American Heart Association/American Stroke Association.

The American Heart Association/American Stroke Association released the adult stroke rehabilitation and recovery guidelines in 2016. A working group of stroke rehabilitation experts reviewed these guidelines and identified a subset of recommendations that were deemed suitable for creating performance measures. These 13 performance measures are reported here and contain inclusion and exclusion criteria to allow calculation of rates of compliance in a variety of settings ranging from acute hospital care to postacute care and care in the home and outpatient setting.

Depressive symptoms after stroke are associated with worse recovery.

OBJECTIVE: More studies are needed on how depressive symptoms in stroke patients can impact outcomes. We evaluated the relationship between depression symptom severity and motor outcomes in a cohort of patients with motor impairment from ischemic stroke. METHOD: We enrolled consecutive ischemic stroke patients without a clinical diagnosis of depression who presented to a single-center urban academic referral hospital. The Patient Health Questionnaire-9 (PHQ-9) scale was used to measure depression symptom severity at three months. Three assessments of motor function were collected at stroke onset and three months: Fugl-Meyer upper extremity (FM-UE), Motricity Index, and Action Research Arm Test (ARAT). We assessed the association between three-month severity on PHQ-9 scores with the outcome measures using univariable and multivariable linear regression models. RESULTS: Fifty-seven patients (mean age 67.8 ± 17.0 years; 50.9% male; 59.6% Caucasian) were included in the final analysis. Mean (standard deviation) outcome scores at three months were PHQ-9: 6.39 (5), Motricity Index: 86.93 (30.04), FM-UE: 52.67 (17.83), and ARAT: 43.77 (20.03). After adjusting for age, initial National Institute of Health Stroke Scale, and if patient discharged after hospitalization on a selective serotonin reuptake inhibitor, sex, and baseline motor outcome, we found that for every point increase in PHQ-9, the Motricity Index decreased by 0.82 points (p = 0.02) and the FM-UE decreased by 0.77 points (p = 0.049). CONCLUSION: Depressive symptoms are common in the stroke population. Depressive symptoms after stroke are associated with multiple types of motor impairments. We need better understanding of the biologic and psychologic aspects of depression involved in stroke recovery.

Functional Measures Upon Admission to Acute Inpatient Rehabilitation Predict Quality of Life After Ischemic Stroke.

OBJECTIVE: To evaluate the association between functional measures at admission to acute inpatient rehabilitation (AIR) and health-related quality of life (HRQOL) scores at 3 months after ischemic stroke. DESIGN: Consecutive patients with ischemic stroke admitted to AIR were consented to a prospective registry. SETTING: Large academic referral inpatient rehabilitation hospital. PARTICIPANTS: Patients (N=113) with ischemic stroke (mean age 70.6 ± 14.5y; 54.0% male; 56.6% white) were included in the analysis. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Admission FIM and Berg Balance Scores (BBS) were abstracted when available. The Neuro-Quality of Life questionnaire was used to assess 3-month HRQOL in 4 domains: upper extremity (UE), lower extremity (LE), executive functions (EF), and general concerns (GC). Associations of FIM and BBS scores with impaired HRQOL at 3 months were evaluated. RESULTS: The median time from stroke onset to admission FIM and BBS was 6.4 (interquartile range [IQR] 4.2-11.3) and 8.9 (IQR 5.8-14.4) days, respectively. A 5-point increase in admission FIM score decreased the likelihood of impairment in HRQOL at 3 months by 25% for GC (odds ratio [OR] 0.75, 95% confidence interval [CI] 0.61-0.93, P=.01), 31% for EF (OR 0.69, 95% CI 0.56-0.85, P=.001), 16% for UE function (OR 0.84, 95% CI 0.73-0.96, P=.01), and 21% for LE function (OR 0.79, 95% CI 0.67-0.93 P=.004). A 5-point increase in admission BBS decreased the likelihood of impairment in HRQOL domains at 3 months by 15% for UE function (OR 0.85, 95% CI 0.75-0.98, P=.02) and 25% for LE function (OR 0.75, 95% CI 0.64-0.89, P=.001). CONCLUSIONS: Admission FIM and BBS were strongly associated with 3-month HRQOL associated across multiple domains following stroke. These findings indicate that HRQOL can be predicted earlier in a patient's course during AIR.

Randomized Sham-Controlled Trial of Navigated Repetitive Transcranial Magnetic Stimulation for Motor Recovery in Stroke.

Background and Purpose- We aimed to determine whether low-frequency electric field navigated repetitive transcranial magnetic stimulation to noninjured motor cortex versus sham repetitive transcranial magnetic stimulation avoiding motor cortex could improve arm motor function in hemiplegic stroke patients when combined with motor training. Methods- Twelve outpatient US rehabilitation centers enrolled participants between May 2014 and December 2015. We delivered 1 Hz active or sham repetitive transcranial magnetic stimulation to noninjured motor cortex before each of eighteen 60-minute therapy sessions over a 6-week period, with outcomes measured at 1 week and 1, 3, and 6 months after end of treatment. The primary end point was the percentage of participants improving ≥5 points on upper extremity Fugl-Meyer score 6 months after end of treatment. Secondary analyses assessed changes on the upper extremity Fugl-Meyer and Action Research Arm Test and Wolf Motor Function Test and safety. Results- Of 199 participants, 167 completed treatment and follow-up because of early discontinuation of data collection. Upper extremity Fugl-Meyer gains were significant for experimental ( P<0.001) and sham groups ( P<0.001). Sixty-seven percent of the experimental group (95% CI, 58%-75%) and 65% of sham group (95% CI, 52%-76%) improved ≥5 points on 6-month upper extremity Fugl-Meyer ( P=0.76). There was also no difference between experimental and sham groups in the Action Research Arm Test ( P=0.80) or the Wolf Motor Function Test ( P=0.55). A total of 26 serious adverse events occurred in 18 participants, with none related to the study or device, and with no difference between groups. Conclusions- Among patients 3 to 12 months poststroke, goal-oriented motor rehabilitation improved motor function 6 months after end of treatment. There was no difference between the active and sham repetitive transcranial magnetic stimulation trial arms. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02089464.

Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association.

PURPOSE: The aim of this guideline is to provide a synopsis of best clinical practices in the rehabilitative care of adults recovering from stroke. METHODS: Writing group members were nominated by the committee chair on the basis of their previous work in relevant topic areas and were approved by the American Heart Association (AHA) Stroke Council's Scientific Statement Oversight Committee and the AHA's Manuscript Oversight Committee. The panel reviewed relevant articles on adults using computerized searches of the medical literature through 2014. The evidence is organized within the context of the AHA framework and is classified according to the joint AHA/American College of Cardiology and supplementary AHA methods of classifying the level of certainty and the class and level of evidence. The document underwent extensive AHA internal and external peer review, Stroke Council Leadership review, and Scientific Statements Oversight Committee review before consideration and approval by the AHA Science Advisory and Coordinating Committee. RESULTS: Stroke rehabilitation requires a sustained and coordinated effort from a large team, including the patient and his or her goals, family and friends, other caregivers (eg, personal care attendants), physicians, nurses, physical and occupational therapists, speech-language pathologists, recreation therapists, psychologists, nutritionists, social workers, and others. Communication and coordination among these team members are paramount in maximizing the effectiveness and efficiency of rehabilitation and underlie this entire guideline. Without communication and coordination, isolated efforts to rehabilitate the stroke survivor are unlikely to achieve their full potential. CONCLUSIONS: As systems of care evolve in response to healthcare reform efforts, postacute care and rehabilitation are often considered a costly area of care to be trimmed but without recognition of their clinical impact and ability to reduce the risk of downstream medical morbidity resulting from immobility, depression, loss of autonomy, and reduced functional independence. The provision of comprehensive rehabilitation programs with adequate resources, dose, and duration is an essential aspect of stroke care and should be a priority in these redesign efforts. (Stroke.2016;47:e98-e169. DOI: 10.1161/STR.0000000000000098.).

Agreement Between Responses From Community-Dwelling Persons With Stroke and Their Proxies on the NIH Neurological Quality of Life (Neuro-QoL) Short Forms.

OBJECTIVE: To examine agreement between patient and proxy responses on the Quality of Life in Neurological Disorders (Neuro-QoL) instruments after stroke. DESIGN: Cross-sectional observational substudy of the longitudinal, multisite, multicondition Neuro-QoL validation study. SETTING: In-person, interview-guided, patient-reported outcomes. PARTICIPANTS: Convenience sample of dyads (N=86) of community-dwelling persons with stroke and their proxy respondents. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Dyads concurrently completed short forms of 8 or 9 items for the 13 Neuro-QoL adult domains using the patient-proxy perspective. Agreement was examined at the scale-level with difference scores, intraclass correlation coefficients (ICCs), effect size statistics, and Bland-Altman plots, and at the item-level with kappa coefficients. RESULTS: We found no mean differences between patients and proxies on the Applied Cognition-General Concerns, Depression, Satisfaction With Social Roles and Activities, Stigma, and Upper Extremity Function (Fine Motor, activities of daily living) short forms. Patients rated themselves more favorably on the Applied Cognition-Executive Function, Ability to Participate in Social Roles and Activities, Lower Extremity Function (Mobility), Positive Affect and Well-Being, Anxiety, Emotional and Behavioral Dyscontrol, and Fatigue short forms. The largest mean patient-proxy difference observed was 3 T-score points on the Lower Extremity Function (Mobility). ICCs ranged from .34 to .59. However, limits of agreement showed dyad differences exceeding ±20 T-score points, and item-level agreement ranged from not significant to weighted kappa=.34. CONCLUSIONS: Proxy responses on Neuro-QoL short forms can complement responses of moderate- to high-functioning community-dwelling persons with stroke and augment group-level analyses, but do not substitute for individual patient ratings. Validation is needed for other stroke populations.

Transcranial direct current stimulation and aphasia: the case of mr. C.

PURPOSE: To illustrate the ethical challenges that arose from investigating a novel treatment procedure, transcranial direct current stimulation (tDCS), in a research participant with aphasia. METHOD: We review the current evidence supporting the use of tDCS in aphasia research, highlighting methodological gaps in our knowledge of tDCS. Then, we examine the case of Mr. C, a person with chronic aphasia who participated in a research protocol investigating the impact of tDCS on aphasia treatment. We describe the procedures that he underwent and the resulting behavioral and neurophysiological outcomes. Finally, we share the steps that were taken to balance beneficence and nonmaleficence and to ensure Mr. C's autonomy. RESULTS: The objective data show that while Mr. C may not have benefitted from participating in the research, neither did he experience any harm. CONCLUSION: Researchers must consider not only the scientific integrity of their studies, but also potential ethical issues and consequences to the research participants.

The minimal clinically important difference of the motricity index score.

INTRODUCTION: The Motricity Index (MI) can predict motor function after rehabilitation, but its minimal clinically important difference (MCID) has not been established. The primary study aim was to estimate the MCID value of the MI arm score. METHODS: Between 2017 and 2018, 173 participants hospitalized with confirmed ischemic stroke were recruited into an observational rehabilitation study. Participants with motor weakness as measured by the Fugl-Meyer upper-extremity (FM-UE) and MI with complete baseline and follow-up assessments at 3 months were included in this analysis. The longitudinal recovery of the MI arm score was anchored to having a poor outcome based on the FM-UE recovery (<9) longitudinally. Results reported include the area-under-curve (AUC), along with sensitivity, specificity, and optimal cut-points based on maximizing the Youden statistic. RESULTS: Sixty-nine patients (median [IQR] age 70 [18] years; 48% male; 54% white) were included in the final analysis. Mean ± standard deviation outcome scores at 3-months were: MI arm: 83.19 ± 22.80; FM-UE: 53.04 ± 17.26. For the primary results, the MI arm score optimal MCID cutoff for observed recovery was 13 points with a sensitivity of 80% (95% Confidence Interval (CI)(67.6%, 92.4%)) and a specificity of 69.0% (95% CI (52.1, 85.8%)), and the AUC was 0.8082 (0.7007, 0.9157). CONCLUSIONS: This was the first study to report the MCID of the MI arm score, as anchored to the FM-UE recovery between acute evaluation and 3-months. The estimated optimal MCID of improvement in the MI arm score was 13 points.

Bone mineral density in patients with stroke: relationship with motor impairment and functional mobility.

PURPOSE: Patients with stroke have a 2- to 4-fold increased risk of hip fracture compared to the general population, because of decreased bone mineral density (BMD) on the paretic side and the high incidence of accidental falls. However, the relationship between BMD and stroke-related motor impairment and functional mobility is not known. The purpose of this study was to investigate these relationships. METHOD: A convenience sample of 87 patients with stroke was recruited from an outpatient rehabilitation clinic. Demographics and clinical history were collected, and patients answered questionnaires regarding functional status. Motor impairment was assessed using motor items of the National Institutes of Health Stroke Scale (NIHSS), and BMD was measured using dual energy X-ray absorptiometry. RESULTS: Mean BMD measured at the total hip was lower on the paretic side relative to the contralateral side (0.883 ± 0.148 g/cm2 vs 0.923 ± 0.136 g/cm2;P < .001). Compared to patients without limitations in walking, those reporting limitations had lower BMD at the paretic total hip (0.808 ± 0.141 g/cm2 vs 0.917 ± 0.139 g/cm2;P = .001) and lower BMDZ scores (-0.282 ± 0.888 vs -0.028 ± 0.813;P = .035). A significant correlation was found between mean BMD and the BMDZ score at the total hip on the paretic side and motor impairment in that lower extremity (r = -0.326,P = .003;r = -0.312,P = .004, respectively). CONCLUSION: In patients with stroke, BMD at the paretic hip correlated with motor impairment. Furthermore, ability to ambulate was shown to be a simple yet useful test to determine which individuals had increased bone loss at the paretic versus nonparetichip.

Locked-In Syndrome: Practical Rehabilitation Management.

Locked-in syndrome is a rare and devastating condition that results in tetraplegia, lower cranial nerve paralysis, and anarthria with preserved cognition, vertical gaze, and upper eyelid movements. Although acute management is much like that of any severe stroke, rehabilitation and recovery of these patients have not been previously described. Challenges relevant to this population include blood pressure management and orthostasis, timing and appropriateness of reinstating oral feeding, ventilatory support, decannulation after tracheostomy, bowel and bladder management, vestibular dysfunction, and eye care. Targeted rehabilitation of head, neck, and trunk stability to improve function, and proper fit in an appropriate wheelchair are essential to assist with mobility. Rehabilitation interventions should include a focus on distal motor control and upright tolerance training followed by balance and mobility exercises. In addition, special considerations must be given to developing early methods of communication through use of augmentative systems to call for help and express needs. These systems along with additional technology provide the basis to promote connectivity to family and friends through the use of social media and the internet. Establishment of communication, mobility, and connectivity is essential in promoting independence, autonomy, and improving quality of life. Overall, with specialized rehabilitative care and access to the proper equipment, long-term outcomes and quality of life in these patients can be favorable.

Gait Measures at Admission to Inpatient Rehabilitation after Ischemic Stroke Predict 3-Month Quality of Life and Function.

BACKGROUND: Ischemic stroke can impact a patient's quality of life, but the extent is unknown. OBJECTIVE: To evaluate the association between gait measures during inpatient rehabilitation with quality-of-life scores and function at 3 months in patients with stroke. SETTING: Single-Center inpatient rehabilitation facility. PARTICIPANTS: Eight five patients with ischemic stroke. METHODS: A 6-Minute Walk Test and a 10-Meter Walk Test were recorded on admission to rehabilitation. We analyzed the association between gait function at rehabilitation and 3-month quality of life and poor functional outcome (modified Rankin Scale score >2) using multivariable logistic regression. MAIN OUTCOME: Measures 3-month health related quality of life. RESULTS: Eighty-five patients (mean age 68.3 14.9 years; 54.3% male) were enrolled. In adjusted analyses, an increase of 0.31 m/s (ie, 1 SD) on the 10-meter walk test was linked with a decreased odds of impaired lower extremity quality of life by 94% (odds ratio [OR] 0.06, 95% confidence interval [CI] 0.01-0.52; P =.01), and decreased odds of poor functional outcome by 98% (OR 0.02, 95% CI <0.01-0.47; P =.01). For the 6-minute walk test, an increase of 109.5 meters (ie, 1 SD) was linked with decreased odds of having impaired lower extremity quality of life by 1% (OR 0.99, 95% CI 0.98-1.00; P < .01) and poor functional outcome by 1% (OR 0.99, 95% CI 0.99-1.00; P = .04). CONCLUSION: Gait measurements at rehabilitation can predict 3-month lower extremity quality of life and function.

Central poststroke pain syndrome.

Central poststroke pain (CPSP) syndrome is a rare complication of stroke but a common cause of central pain. CPSP is best managed in a well-coordinated interdisciplinary pain management program. Pharmacological options are available but none have proven optimal efficacy. Adequate pain control can be achieved with careful medication adjustment and a willingness to try different options in a stepwise approach. Motor cortex stimulation (MCS) with noninvasive or implanted electrodes is not currently available in the United States but has shown good efficacy in several clinical trials. MCS combined with medication management may be an option for treating CPSP in the future.

Central pain syndromes.

The management of pain in persons with neurological injuries is challenging and complex. A holistic view and clinical approach are necessary when addressing pain in patients with neurological impairment because interpreting signs and symptoms and deciphering sources of pain is never a straightforward process. This problem is further magnified with the management of central pain syndromes. The best approach is to have a good understanding of the clinical characteristics commonly found in this patient population, in particular for patients with stroke, multiple sclerosis (MS), or spinal cord injury (SCI), as central pain manifests differently between these groups. This paper will focus on the history, clinical presentation, pathophysiology, assessment, and treatment of central pain in patients with these types of neurological conditions. In addition to being at risk for a decline in quality of life, patients with pain syndromes are also prone to adverse responses to treatments (e.g., opioid addiction). It is therefore important to methodically analyze the similarities and differences between patients with different pain syndromes.

Arm Subscore of Motricity Index to Predict Recovery of Upper Limb Dexterity in Patients With Acute Ischemic Stroke.

OBJECTIVE: The aim of this study was to determine whether the arm subscore of the Motricity Index 1 wk after stroke can predict recovery of upper limb function according to the Action Research Arm Test before inpatient rehabilitation facility discharge and at 3-mo outpatient follow-up. DESIGN: This was a prospective cohort study of patients with acute ischemic stroke admitted to a single acute care hospital and affiliated inpatient rehabilitation facility between 2016 and 2018. Upper limb dexterity of the impaired limb was assessed using the arm subscore of the Motricity Index and Action Research Arm Test. Receiver operating characteristic curve analysis was used to determine optimal cutoffs of the initial arm subscore of the Motricity Index for a good functional outcome defined as Action Research Arm Test score of 45 or higher. RESULTS: Ninety-five patients were evaluated at median 6, 26, and 98.5 days after stroke. The median (interquartile range) arm subscore of the Motricity Index at 1 wk was 77 (20.3-93). The median (interquartile range) Action Research Arm Test scores before inpatient rehabilitation facility discharge and at 3-mo outpatient follow-up were 33 (3.5-52) and 52 (34-55.8), respectively. The optimal arm subscore of the Motricity Index to predict Action Research Arm Test score of 45 or higher before inpatient rehabilitation facility discharge and at 3-mo outpatient follow-up were 71 and 58, respectively. CONCLUSIONS: Early arm subscore of the Motricity Index at 1 wk predicts upper limb functional capacity before inpatient rehabilitation facility discharge and at 3-mo outpatient follow-up.

Design for the everest randomized trial of cortical stimulation and rehabilitation for arm function following stroke.

BACKGROUND: Cortical stimulation (CS) combined with rehabilitation may improve upper limb motor function after stroke. OBJECTIVE: Describe the study design for the Everest Clinical Trial, a randomized single-blinded pivotal device trial, testing safety and efficacy of epidural CS delivered during rehabilitation for upper limb motor function in patients with ischemic stroke. METHOD: A total of 174 participants from 21 centers with hemiplegia at least 4 months after acute ischemic stroke are randomized in a 2:1 ratio to investigational or control groups. Investigational patients undergo implantation of cortical electrode and pulse generator and receive 6 weeks of upper limb rehabilitation with subthreshold CS delivered only during therapy. Control group patients receive the same therapy without device implantation or stimulation. Primary outcome measures include the upper extremity Fugl-Meyer (UEFM) score and the arm motor ability test (AMAT) measured at baseline and 1, 4, 12, and 24 weeks following rehabilitation treatment with primary endpoint at 4 weeks following treatment. A successful outcome is defined as an improvement in UEFM of at least 4.5 points and in AMAT of at least 0.21 points from baseline to primary endpoint. A 20% better success rate between investigational and control groups will be considered clinically meaningful. Adverse events occurring during the study will be identified. RESULTS: Not applicable. CONCLUSIONS: The Everest Clinical Trial is the first randomized pivotal trial on the safety and efficacy of direct CS delivered during rehabilitation for recovery of upper limb motor function in patients with ischemic stroke.

Noninvasive Transcranial Magnetic Brain Stimulation in Stroke.

It is likely that transcranial magnetic brain stimulation will be used for the clinical treatment of stroke and stroke-related impairments in the future. The anatomic target and stimulation parameters will likely vary for any clinical focus, be it weakness, pain, or cognitive or communicative dysfunction. Biomarkers may also be useful for identifying patients who will respond best, with a goal to enhance clinical decision making. Combination with drugs or specific types of therapeutic exercise may be necessary to achieve maximal response.

The relation between Ashworth scores and neuromechanical measurements of spasticity following stroke.

BACKGROUND: Spasticity is a common impairment that follows stroke, and it results typically in functional loss. For this reason, accurate quantification of spasticity has both diagnostic and therapeutic significance. The most widely used clinical assessment of spasticity is the modified Ashworth scale (MAS), an ordinal scale, but its validity, reliability and sensitivity have often been challenged. The present study addresses this deficit by examining whether quantitative measures of neural and muscular components of spasticity are valid, and whether they are strongly correlated with the MAS. METHODS: We applied abrupt small amplitude joint stretches and Pseudorandom Binary Sequence (PRBS) perturbations to both paretic and non-paretic elbow and ankle joints of stroke survivors. Using advanced system identification techniques, we quantified the dynamic stiffness of these joints, and separated its muscular (intrinsic) and reflex components. The correlations between these quantitative measures and the MAS were investigated. RESULTS: We showed that our system identification technique is valid in characterizing the intrinsic and reflex stiffness and predicting the overall net torque. Conversely, our results reveal that there is no significant correlation between muscular and reflex torque/stiffness and the MAS magnitude. We also demonstrate that the slope and intercept of reflex and intrinsic stiffnesses plotted against the joint angle are not correlated with the MAS. CONCLUSION: Lack of significant correlation between our quantitative measures of stroke effects on spastic joints and the clinical assessment of muscle tone, as reflected in the MAS suggests that the MAS does not provide reliable information about the origins of the torque change associated with spasticity, or about its contributing components.