Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy

Study Overview
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Brief Summary
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The study aims to determine the added value of combining high-definition transcranial direct current stimulation (HD-tDCS) in a rehabilitation program based on virtual reality therapy (VRT) to potentiate the effects on neuroplasticity and further improve functional recovery of the arm in chronic stroke patients.

Detailed Description
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Stroke remains the leading cause of acquired disability in France. Moreover, even after the first 3 months of intense arm rehabilitation, 80% of chronic stroke patients don't use their paretic arm in activities of daily living. To this day, despite notable developments, techniques of rehabilitation of the arm for chronic stroke patients are still insufficient. In this context, two promising stroke rehabilitation techniques are to be considered: Virtual reality-based systems provide specific, intensive, repetitive and motivational therapy with real-time feedback of movement and performance which can promote activity-dependent brain neuroplasticity, and therefore functional arm recovery. Thus, virtual reality therapy (VRT), in addition to usual rehabilitation, would improve the function of the arm more effectively as well as daily activities. Non-invasive transcranial direct current stimulation (tDCS) uses constant low intensity (2 mA) continuous electrical currents to modulate the excitability of cortical neurons. Because of its greater focality of neuromodulatory effect that promotes brain neuroplasticity, anodal HD-tDCS to the lesioned hemisphere can improve functional arm recovery after a stroke. In addition, the combined use of the HD-tDCS with a rehabilitation modality, such as constraint induced movement therapy, would potentiate the combined effects of both techniques. Therefore, the investigators hypothesize that the combination of HD-tDCS in a rehabilitation program based on VRT would potentiate the effects on neuroplasticity and would further improve functional recovery of the paretic arm in chronic stroke patients

Official Title
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Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy

Conditions
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Chronic Post Stroke Individuals

Intervention / Treatment
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* Device: HD-tDCS
* Device: Sham HD-tDCS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18 to 90 Patient with more than 3 months of a first cerebrovascular accident whatever the aetiology Patient with paresis of the upper extremity (FM-UE ≥ 15) Exclusion Criteria: Failure to collect written informed consent after a period of reflection Not be affiliated with a French social security scheme or beneficiary of such a scheme Major deficit of the upper extremity (FM-UE <15) History of epilepsy Presence of a pacemaker or a metallic object implanted in the head Pregnant or lactating Severe neglect or attention deficit disorder (omission of more than 15 bells in the Bell's test) Severe cognitive impairment (Mini Mental Score <24) Aphasia with impairment of understanding (Boston Aphasia Quotient <4/5) Under guardianship or curatorship Protected by law

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HD-tDCS and Virtual Reality Therapy<br>Patients will receive their usual rehabilitation program each day, which includes a conventional session (30min) and virtual reality therapy session (Armeo Spring) combined with real stimulation (30min) over 13 consecutive training days (3 weeks) | Device: HD-tDCS<br>* Real stimulation (2mA, 20min) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes  4cm away<br>* Other names: Starstim8 (Neuroelectrics, Spain);|
| Sham Comparator: Sham stimulation and Virtual Reality Therapy<br>Patients will receive their usual rehabilitation program each day, which includes a conventional session (30min) and virtual reality therapy session (Armeo Spring) combined with Sham stimulation (30min) over 13 consecutive training days (3 weeks) | Device: Sham HD-tDCS<br>* Sham stimulation (2mA, ramp up and down phases of 30s) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes  4cm away<br>* Other names: Starstim8 (Neuroelectrics, Spain);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Functional Motor capacity of the upper extremity | Arm functional capacity assessed by the Wolf Motor Function Test (WMFT) (0-75, where higher scores mean better arm functional capacity) | Change from Baseline at Day 21(after intervention) and 3 months after day 21 | 
| Change in Functional Motor capacity of the upper extremity | Arm functional capacity assessed by the Wolf Motor Function Test (WMFT) (0-75, where higher scores mean better arm functional capacity) | Change from Day 21 at 3 months (retention) | 
| Change in Motor deficit of the upper extremity | Measured by the Fugl-Meyer Upper Extremity (FMUE) score (0-66, where higher scores mean a better recovery) | Change from Baseline at Day 21 (after intervention) and 3 months after day 21 | 
| Change in Motor deficit of the upper extremity | Measured by the Fugl-Meyer Upper Extremity (FMUE) score (0-66, where higher scores mean a better recovery) | Change from Day 21 at 3 months (retention) | 
| Change in Hand dexterity | Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity) | Change in Baseline at Day 21 (after intervention) and 3 months after day 21 | 
| Change in Hand dexterity | Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity) | Change in Day21 at 3 months (retention) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Non-use of the paretic upper extremity | Measured by the Proximal Arm Non-Use (PANU) score during an arm reaching task (0-100 where higher scores mean a worse outcome) | Change from Baseline at Day 21 (after intervention) and 3 months after day 21 | 
| Change in Non-use of the paretic upper extremity | Measured by the Proximal Arm Non-Use (PANU) score during an arm reaching task (0-100 where higher scores mean a worse outcome) | Change from Day 21 at 3 months (retention) | 
| Change in Activities of daily living | Measured by the Barthel Index (0-100 where higher scores mean a better outcome) | Change from Baseline at Day 21 (after intervention) and 3 months after day 21 | 
| Change in Activities of daily living | Measured by the Barthel Index (0-100 where higher scores mean a better outcome) | Change from Day 21 at 3 months (retention) | 
| The use of the paretic upper extremity in activities of daily living | Measured by the magnitude and ratio of arm movements over a 10-day period from wrist worn accelerometers on each arm | Change from Baseline at Post (10 days after the intervention), and Post 3 months (10 days at 3 months post intervention) | 
| The use of each upper extremity in activities of daily living | Measured by the magnitude and ratio of arm movements over a 10-day period from wrist worn accelerometers on each arm | Change from Post at Post 3 months (retention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, HD-tDCS, Virtual Reality Therapy, Physical therapy