Montpellier hospital Lapeyronie
Montpellier, 34000, France
NCT Number: NCT04291573
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.
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Notify Me18 year–90 year
All sexes
Interventional
Not applicable
Montpellier, 34000, France
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:
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Real stimulation (2mA, 20min) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes ~4cm away
Other names: Starstim8 (Neuroelectrics, Spain)
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: Starstim8 (Neuroelectrics, Spain)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Change from Day 21 at 3 months (retention)
Measured by the Barthel Index (0-100 where higher scores mean a better outcome)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
University Hospital, Montpellier
Other
Acronym: ReArm
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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