NCT05884762 earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke
| NCT ID | NCT05884762 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rennes University Hospital |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-02-20 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-02-20 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this study is to evaluate the effect of early rehabilitation treatment by electroencephalographic neurofeedback on upper limb motor function after stroke. Researchers will compare : Interventional group: electroencephalographic neurofeedback + traditional reference rehabilitation programme Control group: SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme
Eligibility 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.)
Contact & Investigator
Simon BUTET, MD
PRINCIPAL INVESTIGATOR
Rennes CHU
Frequently Asked Questions
Who can join the NCT05884762 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05884762 currently recruiting?
Yes, NCT05884762 is actively recruiting participants. Contact the research team at loic.jacob@chu-rennes.fr for enrollment information.
Where is the NCT05884762 trial being conducted?
This trial is being conducted at Rennes, France.
Who is sponsoring the NCT05884762 clinical trial?
NCT05884762 is sponsored by Rennes University Hospital. The principal investigator is Simon BUTET, MD at Rennes CHU. The trial plans to enroll 40 participants.
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