earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

NCT ID: NCT05884762

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-20
• Study Completion Date: 2026-01-20

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

Conditions

Stroke; Stroke Hemorrhagic; Stroke, Ischemic; Stroke Rehabilitation; Brain Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Interventional group

electroencephalographic neurofeedback + traditional reference rehabilitation programme

Group Type: EXPERIMENTAL

electroencephalographic neurofeedback

Intervention Type: OTHER

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.

Control group

SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme

Group Type: SHAM_COMPARATOR

SHAM electroencephalographic neurofeedback

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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

Intervention Type: OTHER

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation de l'Avenir

OTHER

Sponsor Role: collaborator

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon BUTET, MD

Role: PRINCIPAL_INVESTIGATOR

Rennes CHU

Locations

Rennes Chu

Rennes, , France

Site Status: RECRUITING

Countries

France

Central Contacts

LOÏC JACOB

Role: CONTACT

loic.jacob@chu-rennes.fr

0299282555

Facility Contacts

Simon BUTET, MD

Role: primary

simon.butet@chu-rennes.fr

0299284218

Other Identifiers

2023-A01150-45

Identifier Type: REGISTRY

Identifier Source: secondary_id

35RC22_9743_YUWIN-Stroke

Identifier Type: -

Identifier Source: org_study_id