Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID05884762

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

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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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