Transcranial Direct Current Stimulation Acute Stroke Walking

Study Overview
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Brief Summary
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16 acute stroke patients will be split into 2 groups. One group will receive the real treatment (anodal tDCS) and one group sham. Subjects will receive, in addition to conventional rehabilitation, 2mA for 20 mins of their attributed tDCS, 5 times a week. Evaluations will take place before the first stimulation period (48h post stroke), after 1, 2, 3 and 4 weeks. The evaluations are the Four Square Step Test, the Berg Balance Scale, the Postural Assessment Scale For Stroke, the Trunk Impairment Scale, the Time Up & Go and the 10 meter walking test.

Official Title
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Transcranial Direct Current Stimulation Improves Walking and Balance in Acute Stroke Patients - a Randomized, Double-blind, Sham-controlled Study

Conditions
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Acute Stroke

Intervention / Treatment
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* Device: Anodal Transcranial Direct Current Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First Ever Stroke Motor or sensory deficit Understands and follows orders Signed inform consent Exclusion Criteria: • One Yes on the medium and high risk sections of the TSST (Bornheim et al.,2019)

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: One group receives anodal tDCS, one placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Anode placed over the affected primary motor cortex, cathode over contralateral supra orbital area. 2 mA, 20min stimulation, 5 days a week for 4 weeks | Device: Anodal Transcranial Direct Current Stimulation<br>* Subjects received a micro-current through their scalp to induce cortical and subcortical changes<br>* Other names: tDCS;|
| Placebo Comparator: Placebo<br>Anode montage but current is ramped up over 15 secondes, then ramped down. 2 mA, 20min stimulation, 5 days a week for 4 weeks | Device: Anodal Transcranial Direct Current Stimulation<br>* Subjects received a micro-current through their scalp to induce cortical and subcortical changes<br>* Other names: tDCS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes Four Square Step Test | The subject is required to sequentially step over four canes set-up in a cross configuration on the ground. The faster the score, the better the patients balance and coordination. | Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4 | 
| Changes Berg Balance Scale | Balance Test. Minimum score is 0, maximum 36. The higher the score, the better the balance. | Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4 | 
| Changes Postural Assessment Scale For Stroke | alance Test. Minimum score is 0, maximum 56. The higher the score, the better the balance. | Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4 | 
| Changes Trunk Impairment Scale | alance Test. Minimum score is 0, maximum 23. The higher the score, the better the balance. | Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4 | 
| Changes Time Up & Go | To determine fall risk and measure the progress of balance, sit to stand and walking. The faster, the better. | Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4 | 
| Changes 10 meter walking test | 10 meter walking test, the faster the better | Pre Stimulation (48 hours post stroke), Week 1, Week 2, Week 3, Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Stroke, tDCS, Anodal, Balance, Walking