ReArm: Recovering Arm Function in Chronic Post-stroke Patients Using Combined HD-tDCS and Virtual Reality Therapy
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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:
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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.
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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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: HD-tDCS and Virtual Reality Therapy 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
Real stimulation (2mA, 20min) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes ~4cm away
Other Names:
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| Sham Comparator: Sham stimulation and Virtual Reality Therapy 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
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
Other Names:
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Outcome Measures
Primary Outcome Measures
- Change in Functional Motor capacity of the upper extremity [Change from Baseline at Day 21(after intervention) and 3 months after day 21]
Arm functional capacity assessed by the Wolf Motor Function Test (WMFT) (0-75, where higher scores mean better arm functional capacity)
- Change in Functional Motor capacity of the upper extremity [Change from Day 21 at 3 months (retention)]
Arm functional capacity assessed by the Wolf Motor Function Test (WMFT) (0-75, where higher scores mean better arm functional capacity)
- Change in Motor deficit of the upper extremity [Change from Baseline at Day 21 (after intervention) and 3 months after day 21]
Measured by the Fugl-Meyer Upper Extremity (FMUE) score (0-66, where higher scores mean a better recovery)
- Change in Motor deficit of the upper extremity [Change from Day 21 at 3 months (retention)]
Measured by the Fugl-Meyer Upper Extremity (FMUE) score (0-66, where higher scores mean a better recovery)
- Change in Hand dexterity [Change in Baseline at Day 21 (after intervention) and 3 months after day 21]
Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity)
- Change in Hand dexterity [Change in Day21 at 3 months (retention)]
Measured by the Box and Block Test (BBT) score (greater number of blocks moved in 1minute means better hand dexterity)
Secondary Outcome Measures
- Change in Non-use of the paretic upper extremity [Change from Baseline at Day 21 (after intervention) and 3 months after day 21]
Measured by the Proximal Arm Non-Use (PANU) score during an arm reaching task (0-100 where higher scores mean a worse outcome)
- Change in Non-use of the paretic upper extremity [Change from Day 21 at 3 months (retention)]
Measured by the Proximal Arm Non-Use (PANU) score during an arm reaching task (0-100 where higher scores mean a worse outcome)
- Change in Activities of daily living [Change from Baseline at Day 21 (after intervention) and 3 months after day 21]
Measured by the Barthel Index (0-100 where higher scores mean a better outcome)
- Change in Activities of daily living [Change from Day 21 at 3 months (retention)]
Measured by the Barthel Index (0-100 where higher scores mean a better outcome)
- The use of the paretic upper extremity in activities of daily living [Change from Baseline at Post (10 days after the intervention), and Post 3 months (10 days at 3 months post intervention)]
Measured by the magnitude and ratio of arm movements over a 10-day period from wrist worn accelerometers on each arm
- The use of each upper extremity in activities of daily living [Change from Post at Post 3 months (retention)]
Measured by the magnitude and ratio of arm movements over a 10-day period from wrist worn accelerometers on each arm
Other Outcome Measures
- Change in Interhemispheric Sensorimotor cortex haemodynamics (functional near-infrared spectroscopy-fNIRS) [Change from Baseline at Day 21 (after intervention)]
Measured by the magnitude and ratio of the concentration of oxygenated haemoglobin in the ipsilesional and contralesional sensorimotor cortex at rest and during arm movements
- Change in Interhemispheric Sensorimotor cortex haemodynamics (functional near-infrared spectroscopy-fNIRS) [Change from Day 21 at 3 months (retention)]
Measured by the magnitude and ratio of the concentration of oxygenated haemoglobin in the ipsilesional and contralesional sensorimotor cortex at rest and during arm movements
- Change in Interhemispheric Sensorimotor cortex neural oscillations (Electroencephalography- EEG) [Change from Baseline at Day 21 (after intervention)]
Measured by the magnitude and ratio of alpha/beta frequency power in the ipsilesional and contralesional sensorimotor cortex at rest and during arm movements
- Change in Interhemispheric Sensorimotor cortex neural oscillations (Electroencephalography- EEG) [Change from Day 21 at 3 months (retention)]
Measured by the magnitude and ratio of alpha/beta frequency power in the ipsilesional and contralesional sensorimotor cortex at rest and during arm movements
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient aged 18 to 90
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Patient with more than 3 months of a first cerebrovascular accident whatever the aetiology
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Patient with paresis of the upper extremity (FM-UE ≥ 15)
Exclusion Criteria:
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Failure to collect written informed consent after a period of reflection
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Not be affiliated with a French social security scheme or beneficiary of such a scheme
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Major deficit of the upper extremity (FM-UE <15)
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History of epilepsy
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Presence of a pacemaker or a metallic object implanted in the head
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Pregnant or lactating
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Severe neglect or attention deficit disorder (omission of more than 15 bells in the Bell's test)
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Severe cognitive impairment (Mini Mental Score <24)
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Aphasia with impairment of understanding (Boston Aphasia Quotient <4/5)
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Under guardianship or curatorship
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Protected by law
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Montpellier hospital Lapeyronie | Montpellier | France | 34000 |
Sponsors and Collaborators
- University Hospital, Montpellier
- Université Montpellier
- Groupement Interrégional de Recherche Clinique et d'Innovation
- IMT Mines Alès
Investigators
- Principal Investigator: Karima KA Bakhti, PhD, Montpellier hospital Lapeyronie
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- UF 7780