earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

NCT05884762 · tracked via the Priya Life Science France tracker

Sponsor

Rennes University Hospital

Phase

Not applicable

Started

2024-02-20

Last updated

2026-03-03

Condition(s) studied

StrokeStroke HemorrhagicStroke, IschemicStroke RehabilitationBrain Infarction

Investigational drug(s) / intervention(s)

electroencephalographic neurofeedbackSHAM electroencephalographic neurofeedback

electroencephalographic neurofeedback: The patient is installed in a quiet, isolated room in the Physical Medicine and Rehabilitation Department. The patient sits comfortably in front of a computer. A nurse or a rehabilitator installs the EEG headset and places gel in the electrodes (x32). Connecting the amplifier and interface. Checking the correct positioning and contact of the electrodes (impedance). * Calibration phase at rest. * Working phase: the sessions last 24 minutes. The patient will be asked to concentrate on the affected arm, and to imagine a movement of this arm, to feel the sensations, without any real movement of the arm. * In the Neurofeedback group, the patient will receive visual feedback of a virtual hand moving on a computer screen in front of him/her, depending on his/her brain activations. He will also receive haptic feedback (vibrations) in the flexor muscles of his wrist.

SHAM electroencephalographic neurofeedback: The patient is installed in a quiet, isolated room in the Physical Medicine and Rehabilitation Department. The patient sits comfortably in front of a computer. A nurse or a rehabilitator installs the EEG headset and places gel in the electrodes (x32). Connecting the amplifier and interface. Checking the correct positioning and contact of the electrodes (impedance). * Calibration phase at rest. * Working phase: the sessions last 24 minutes. The patient will be asked to concentrate on the affected arm, and to imagine a movement of this arm, to feel the sensations, without any real movement of the arm. * In the SHAM group, the visual feedback and haptic feedback are randomly generated

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.)

Primary outcome measure(s)

Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity — 28 days
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity

Trial sites (1)

Facility	City	Region	Status
Rennes Chu	Rennes	France	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05884762 on ClinicalTrials.gov ↗ ← All trials in France