tDCS and Motor Training and Motor Deficit After Stroke

Study Overview
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Brief Summary
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This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on grip strength, motor performance and functional use of the affected arm in population of chronic stroke patients.

Detailed Description
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A growing body of evidence are available regarding the effectiveness of anodal transcranial direct current stimulation (tDCS) in patients with chronic hand motor impairment as a stroke consequence. This study investigated the combined effects of anodal tDCS and intensive motor training (MT) vs. sham stimulation with MT (control intervention) on objective evaluation of fine and gross motor hand function using simulated activities of daily living (Jebsen-Taylor hand function test), grip strength, motor performance and functional use of the affected arm in this population of patients. Patients with chronic hand motor deficits after stroke (> 12 months) are randomly assigned to active stimulation or a control intervention arm in a double-blinded, sham-controlled, parallel design. Each group received intensive MT for 45 min/day, 5 days/week, for 2 weeks, which was preceded by 20 minutes of 2 milliampere of anodal tDCS over the ipsilesional M1 vs. sham tDCS. Outcome measures are tested at baseline (T0), and after the intervention Day 1 (T1), after stimulation protocol completion Day 10 (T2) and 30 days later (T3).

Official Title
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Effects of Anodal tDCS and Motor Training on Chronic Motor Deficit After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: tDCS (Endomed 482; Enraf-Nonius B.V.)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of stroke made by clinical features and documented by neuroimaging studies (CT or MRI scans stroke duration > 12 months severe hand deficit at stroke onset (Medical Research Council grade <2) and subsequently recovered to the level moderate hand deficit with presence of hand movements evaluated by the Fugl-Meyer upper-extremity Assessment (FMA) of Motor Recovery after Stroke between 28-50 points (max. 66 pts), spasticity between 0-2 assessed on the Modified Ashworth Scale Exclusion Criteria: any clinically significant or unstable medical disorder, diagnosis od major depression, diagnosis odf substance or alcohol abuse or any neurological disorder other than stroke, including neglect, aphasia, hemianopsia and serious cognitive impairment (Mini-Mental State Examination < 24). any contraindications to tDCS, including histories of seizure, cerebral aneurysm, and prior surgery involving metallic implants

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment<br>Group of patients on active treatment will receive intensive motor training for 45 min/day, 5 days/week, for 2 weeks, which would be preceded by 20 minutes of 2 mA anodal tDCS over the ipsilesional motor cortex. | Device: tDCS (Endomed 482; Enraf-Nonius B.V.)<br>* non-invasive brain stimulation with pair of electrodes with saline-soaked pads through which the direct current of intensity of 2 mA is delivered<br>|
| Sham Comparator: Sham comparator<br>Group of patients on sham treatment will receive intensive motor training for 45 min/day, 5 days/week, for 2 weeks, which would be preceded by sham tDCS over the ipsilesional motor cortex. | Device: tDCS (Endomed 482; Enraf-Nonius B.V.)<br>* non-invasive brain stimulation with pair of electrodes with saline-soaked pads through which the direct current of intensity of 2 mA is delivered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Jebsen Taylor Test of Hand Function | changes of baseline summed times to complete six individual tasks (from JTT-2 to JTT7) and is performed with each hand separately | one day, two weeks and one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hand grip force | changes of baseline maximum grip force of the hand measured by whole-hand dynamometer | two weeks and one month | 
| upper limb Fugl-Meyer assessment of Motor Recovery after Stroke | changes of initial score from domain of motor functions for upper limb | one day, two weeks and one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tDCS, motor recovery