YUWIN-Stroke: earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

Sponsor

Rennes University Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05884762

Collaborator

Fondation de l'Avenir (Other)

Enrollment

Location

Arms

17.1

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Stroke Stroke Hemorrhagic Stroke, Ischemic Stroke Rehabilitation Brain Infarction	Other: electroencephalographic neurofeedback Other: SHAM electroencephalographic neurofeedback	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Masking Description:

The occupational therapist who will include and do the sessions will be open. The assessors who will test motor functions during the assessments will be blind

Primary Purpose:

Treatment

Official Title:

earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Feb 1, 2025

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Interventional group electroencephalographic neurofeedback + traditional reference rehabilitation programme	Other: 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 Comparator: Control group SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme	Other: 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

Arm

Intervention/Treatment

Experimental: Interventional group

electroencephalographic neurofeedback + traditional reference rehabilitation programme

Other: 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 Comparator: Control group

SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme

Other: 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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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 on day 3 of 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.