Actively Recruiting
Early Upper Limb Rehabilitation With EEG-Neurofeedback After Stroke
Led by Rennes University Hospital · Updated on 2026-03-03
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rennes University Hospital
Lead Sponsor
F
Fondation de l'Avenir
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effect of early rehabilitation using electroencephalographic (EEG) neurofeedback on upper limb motor function in adults who have recently had a stroke. The study compares two groups: one receiving EEG neurofeedback combined with traditional rehabilitation, and a control group receiving sham EEG neurofeedback alongside the same traditional rehabilitation. The trial focuses on improving motor function after ischemic or hemorrhagic stroke with upper limb deficits. Participants receive treatment in a quiet room where an EEG headset with 32 electrodes is placed. During sessions lasting 24 minutes, patients concentrate on their affected arm and imagine its movement without actual motion. The experimental group receives visual feedback of a virtual hand moving on a screen and haptic feedback through wrist vibrations based on brain activity, while the control group receives randomly generated feedback. Both groups continue traditional rehabilitation throughout the study. Participants are assessed using various motor function tests, including the Fugl-Meyer Assessment for upper extremity function at 28 days, along with range of motion, grip strength, arm use logs, and functional independence scales at 28 days and 3 months. Brain activity is monitored using EEG and fMRI scans to evaluate cerebral activation changes. Researchers also gather feedback on the acceptability of the neurofeedback protocol from healthcare professionals. The study is randomized and triple-blinded, with follow-up assessments lasting up to 3 months after treatment.
CONDITIONS
Brief Title
earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral ischemic or hemorrhagic stroke
- Adult aged 18 to 80 years, any sex
- Stroke occurred less than 3 weeks ago
- Upper limb deficit with Shoulder Abduction Finger Extension score less than 5 measured within 7 days after stroke
- No comprehension problems that limit participation
- May have homonymous lateral hemianopia or visuospatial hemineglect
- Signed free and informed consent by patient or family member if patient has motor difficulties
- Affiliated to French social security
You will not qualify if you...
- Brain stem or cerebellum involvement by ischemic or hemorrhagic stroke
- Multiple strokes
- Stroke less than 1 week old
- Aphasia with major comprehension impairment
- Contraindications to MRI including pacemaker, implantable defibrillator, neurosurgical clips, cochlear implants, metallic foreign bodies in orbit or brain, recent stents or osteosynthesis devices, or claustrophobia
- Patients who have undergone thrombolysis or thrombectomy may be included
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive electroencephalographic neurofeedback or sham neurofeedback combined with traditional rehabilitation. Sessions last 24 minutes and involve concentration and motor imagery of the affected arm with visual and haptic feedback.
Multiple neurofeedback sessions within 28 days
Duration - Up to 3 months
Participants are assessed for motor function and brain activity improvements after treatment, including evaluations up to 3 months.
Assessments at 28 days and 3 months
Trial Site Locations
Total: 1 location
1
Rennes Chu
Rennes, France, 35000
Actively Recruiting
Research Team
L
LOÏC JACOB
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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