earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke (YUWIN-Stroke)

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

Study Overview

• Status: Recruiting
• Conditions: Stroke; Brain Infarction; Stroke, Ischemic; Stroke Hemorrhagic; Stroke Rehabilitation
• Intervention / Treatment: Other: electroencephalographic neurofeedback; Other: SHAM electroencephalographic neurofeedback

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: LOÏC JACOB; Phone Number: 0299282555; Email: loic.jacob@chu-rennes.fr

Study Locations

• France
  • Rennes, France, 35000
    • Recruiting
    • Rennes Chu
    • Contact: Simon BUTET, MD; Phone Number: 0299284218; Email: simon.butet@chu-rennes.fr
    • Principal Investigator: Simon BUTET, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity	Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in ACTIVE RANGE OF MOTION (CxA) composite score	Changes in ACTIVE RANGE OF MOTION (CxA) composite score	28 days
Changes in ACTIVE RANGE OF MOTION (CxA) composite score	Changes in ACTIVE RANGE OF MOTION (CxA) composite score	3 months
Changes in Action Research Arm Test (ARAT) score	Changes in Action Research Arm Test (ARAT) score	28 days
Changes in Action Research Arm Test (ARAT) score	Changes in Action Research Arm Test (ARAT) score	3 months
Changes in force emitted (in kg) during a palmar grip (JAMAR)	Changes force emitted (in kg) during a palmar grip (JAMAR)	28 days
Changes in force emitted (in kg) during a palmar grip (JAMAR)	Changes force emitted (in kg) during a palmar grip (JAMAR)	3 months
Progression in Evaluation of the Motor activiy Log (MAL)	Progression in Evaluation of the Motor activiy Log (MAL)	28 days
Progression in Evaluation of the Motor activiy Log (MAL)	Progression in Evaluation of the Motor activiy Log (MAL)	3 months
Progression in The Composite Functional Independence Scale (MIF)	Progression in The Composite Functional Independence Scale (MIF)	28 days
Progression in The Composite Functional Independence Scale (MIF)	Progression in The Composite Functional Independence Scale (MIF)	3 months
Progression in The Stroke Impact Scale (SIS)	Progression in The Stroke Impact Scale (SIS)	28 days
Progression in The Stroke Impact Scale (SIS)	Progression in The Stroke Impact Scale (SIS)	3 months
Brain activity measured by electroencephalogram : improvement in cerebral activations in target zones	Brain activity measured by electroencephalogram : improvement in cerebral activations in target zones	28 days
Brain datas (fMRI activity and CST tractography)	Brain datas (fMRI activity and CST tractography)	28 days
Acceptability of overseeing the neurofeedback protocol among healthcare professionals (semi-open interviews)	Assessing the a priori acceptance (acceptability) of overseeing neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by semi-open interviews	3 months
Acceptability of overseeing the neurofeedback protocol among healthcare professionals (questionnaires)	Assessing the a priori acceptance (acceptability) of overseeing the neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by questionnaires.	3 months
Acceptance of overseeing the neurofeedback protocol among healthcare professionals (semi-open interviews)	Assessing the retrospective adoption (acceptance) of overseeing the neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by semi-open interviews	3 months
Acceptance of overseeing the neurofeedback protocol among healthcare professionals (questionnaires)	Assessing the retrospective adoption (acceptance) of overseeing the neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by questionnaires.	3 months

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Collaborators: Fondation de l'Avenir
• Investigators: Principal Investigator: Simon BUTET, MD, Rennes Chu

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Rehabilitation; neurofeedback; Stroke; Upper Limb
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Ischemia; Infarction; Necrosis; Ischemia; Pathological Conditions, Signs and Symptoms; Ischemic Stroke; Hemorrhagic Stroke; Stroke; Brain Infarction
• Other Study ID Numbers: 35RC22_9743_YUWIN-Stroke; 2023-A01150-45 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No