Early rehabilitation using EEG neurofeedback for stroke recovery
earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke
NA · Rennes University Hospital · NCT05884762
This study tests if using brainwave feedback along with regular rehab can help stroke patients recover better use of their arms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Rennes University Hospital (other) |
| Locations | 1 site (Rennes) |
| Trial ID | NCT05884762 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of early rehabilitation treatment using electroencephalographic neurofeedback to improve upper limb motor function in patients who have experienced a stroke. Participants will be divided into two groups: one receiving neurofeedback combined with traditional rehabilitation, and the other receiving a sham neurofeedback treatment alongside traditional rehabilitation. The goal is to determine if the neurofeedback approach can enhance recovery outcomes compared to standard care alone.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 who have experienced a unilateral ischemic or hemorrhagic stroke within the last three weeks and have upper limb deficits.
Not a fit: Patients with brain stem or cerebellum involvement, multiple strokes, or significant comprehension impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve upper limb recovery in stroke patients, leading to better functional independence.
How similar studies have performed: While the use of neurofeedback in rehabilitation is a growing field, this specific approach is relatively novel and has not been extensively tested in stroke recovery.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral ischaemic or haemorrhagic stroke * Adult (18-80 years), both sexes * Stroke \< 3 weeks * Upper limb deficit defined by Shoulder Abduction Finger Extension score \<5 measured during the 7 days following stroke; i.e., patients predicted to have incomplete recovery * No participation-limiting comprehension problems * With or without homonymous lateral hemianopia; with or without visuospatial hemineglect * Free, informed and written consent signed by the patient or a member of the patient's family (in the case of a patient who is able to understand the information and give consent but has motor difficulties resulting in an invalid signature). * Affiliated to french social security Exclusion Criteria: * Ischemic or hemorrhagic brain stem and/or cerebellum involvement * Multiple strokes * Stroke \< 1 week; in order not to be deleterious by starting active rehabilitation too early after immediate stroke * Aphasia with major comprehension impairment * Contraindication to MRI * pacemaker or implantable defibrillator, * neurosurgical clips, * cochlear implants, * intra-orbital or encephalic metallic foreign bodies, * stents placed less than 4 weeks ago and osteosynthesis devices placed less than 6 weeks ago, * claustrophobia. (Patients who have undergone thrombolysis or thrombectomy may be included in the study.)
Where this trial is running
Rennes
- Rennes Chu — Rennes, France (RECRUITING)
Study contacts
- Principal investigator: Simon BUTET, MD — Rennes CHU
- Study coordinator: LOÏC JACOB
- Email: loic.jacob@chu-rennes.fr
- Phone: 0299282555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Stroke, Stroke Hemorrhagic, Stroke, Ischemic, Stroke Rehabilitation, Brain Infarction, Rehabilitation, neurofeedback, Upper Limb