Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke

Study Overview
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Brief Summary
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Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke. This study addresses this important issue, by evaluating, in the early phase post-stroke, effects of motor conventional physical therapy associated or not with transcranial direct current stimulation (tDCS).

Detailed Description
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The investigators main goal is to confirm the safety of transcranial direct current stimulation (tDCS) associated with conventional physical therapy, compared to conventional physical therapy associated with sham tDCS, for upper limb rehabilitation in an early phase (72 hours until 6 weeks) after stroke. Patients will be randomized to receive one of these two treatments, 3 times per week, for 2 weeks. Adverse effects will be monitored during each session. The working hypothesis is that conventional physical therapy associated with active tDCS in the subacute phase of ischemic stroke will be as safe as conventional therapy alone. The investigators will also preliminarily evaluate the efficacy of active tDCS associated with conventional therapy, compared to conventional therapy alone, in improvement of upper limb motor impairment. The investigators secondary goals are: 1) To compare effects of the above mentioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke ( subacute phase), immediately after treatment and 3 months later. The investigators hypothesis is that the association of conventional physical therapy and active tDCS will lead to better outcomes than conventional therapy alone. Patients will be assessed before the first session and after the last session of treatment, as well as 3 months after the last session of treatment. Preliminary data about structural and functional connectivity will be collected in order to plan future studies related to mechanisms of tDCS in the subacute phase after stroke.

Official Title
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Safety of Transcranial Direct Current Stimulation in the Subacute Phase After Stroke

Conditions
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Stroke

Intervention / Treatment
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* Device: Active tDCS
* Other: Physical Therapy
* Device: Sham tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ischemic stroke confirmed by computed tomography or magnetic resonance imaging, with onset between 72 hours and 6 weeks before enrollment. Unilateral paresis of upper limb National Institute of Health Stroke Scale ( NIHSS) score of at least 1 point in items 5a or 5b . Ability to provide written informed consent (patient ou legal representative). Exclusion Criteria: Lesions affecting the corticomotor pathway in the hemisphere contralateral to the stroke. Neurologic diseases except migraine. Modified Rankin Scale > 2 prior to stroke. Advanced systemic disease such as cancer or advanced chronic renal disease. Clinical instability such as uncontrolled cardiac arrhythmia or heart failure. Contraindication for physical therapy. Pregnancy. Absolute or relative contraindications to tDCS: metallic prosthesis in the head or neck; lesions on the scalp, history of neurosurgery, pacemaker. Comprehension aphasia Dementia Cerebellar stroke or ataxia caused by involvement of cerebellar pathways in the brainstem

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tDCS+ Physical Therapy<br>Active tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After active session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks) | Device: Active tDCS<br>* Active tDCS will be applied with the anode positioned over the ipsilesional primary motor cortex and the cathode over the contralateral supraorbital region for 20 minutes (1mA).<br>Other: Physical Therapy<br>* Physical therapy will be administered for 60 minutes<br>|
| Sham Comparator: Sham tDCS+Physical Therapy<br>Sham tDCS (transcranial direct current stimulation) will be applied for 20 minutes. After sham session of tDCS, the patient will receive physical therapy for 60 minutes. Number of treatment sessions: 6 (3 times a week, for 2 weeks) | Other: Physical Therapy<br>* Physical therapy will be administered for 60 minutes<br>Device: Sham tDCS<br>* In sham tDCS, no current will be delivered through the tDCS device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the intervention as assessed by frequency of adverse events | frequency of adverse events in the active and sham arms | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement post treatment as measured by the Modified Rankin Scale | Improvement post treatment | 2 weeks and 14 weeks | 
| Improvement post treatment as measured by the NIH Stroke Scale | Improvement post treatment | 2 weeks and 14 weeks | 
| Improvement post treatment as measured by the Stroke Impact Scale | Improvement post treatment | 2 weeks and 14 weeks | 
| Upper limb subscale of Fugl Meyer Assessment of Sensorimotor recovery after stroke | Improvement post treatment | 2 weeks and 14 weeks | 
| Improvement post treatment as measured by the Modified Ashworth Scale | Improvement post treatment | 2 weeks and 14 weeks | 
| Improvement post treatment as measured by the Motor Activity Log | Improvement post treatment | 2 weeks and 14 weeks | 
| Montreal Cognitive Assessment Test | No cognitive deterioration post treatment | 2 weeks and 14 weeks | 
| Structural Connectivity as measured by diffusion tensor imaging analysis | Improvement post treatment | 2 weeks | 
| Functional Connectivity as measured by resting-state functional magnetic imaging analysis | Improvement post treatment | 2 weeks | 
| Improvement post treatment as measured by the Barthel index | Improvement post treatment | 2 week and 14 weeks | 
| Safety of the intervention as assessed by frequency of adverse events | frequency of adverse events in the active and sham arms | 14 weeks | 
| Improvement post treatment as measured by Pittsburgh Sleep Quality Index | Improvement post treatment | 2 week and 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transcranial direct current stimulation, conventional physical therapy