earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

Stroke Clinical Trial

— YUWIN-Stroke  

Official title:

earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884762
• Other study ID #: 35RC22_9743_YUWIN-Stroke
• Secondary ID: 2023-A01150-45
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: January 20, 2026

Study information

• Verified date: February 2024
• Source: Rennes University Hospital
• Contact: LOÏC JACOB
• Phone: 0299282555
• Email: loic.jacob[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 20, 2026
• Est. primary completion date: September 20, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Infarction
• Hemorrhagic Stroke
• Infarction
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke Rehabilitation
• Stroke, Ischemic

Intervention

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 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

Locations

Country	Name	City	State
France	Rennes Chu	Rennes

Sponsors (2)

Lead Sponsor	Collaborator
Rennes University Hospital	Fondation de l'Avenir

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in ACTIVE RANGE OF MOTION (CxA) composite score	Changes in ACTIVE RANGE OF MOTION (CxA) composite score	28 days
Secondary	Changes in ACTIVE RANGE OF MOTION (CxA) composite score	Changes in ACTIVE RANGE OF MOTION (CxA) composite score	3 months
Secondary	Changes in Action Research Arm Test (ARAT) score	Changes in Action Research Arm Test (ARAT) score	28 days
Secondary	Changes in Action Research Arm Test (ARAT) score	Changes in Action Research Arm Test (ARAT) score	3 months
Secondary	Changes in force emitted (in kg) during a palmar grip (JAMAR)	Changes force emitted (in kg) during a palmar grip (JAMAR)	28 days
Secondary	Changes in force emitted (in kg) during a palmar grip (JAMAR)	Changes force emitted (in kg) during a palmar grip (JAMAR)	3 months
Secondary	Progression in Evaluation of the Motor activiy Log (MAL)	Progression in Evaluation of the Motor activiy Log (MAL)	28 days
Secondary	Progression in Evaluation of the Motor activiy Log (MAL)	Progression in Evaluation of the Motor activiy Log (MAL)	3 months
Secondary	Progression in The Composite Functional Independence Scale (MIF)	Progression in The Composite Functional Independence Scale (MIF)	28 days
Secondary	Progression in The Composite Functional Independence Scale (MIF)	Progression in The Composite Functional Independence Scale (MIF)	3 months
Secondary	Progression in The Stroke Impact Scale (SIS)	Progression in The Stroke Impact Scale (SIS)	28 days
Secondary	Progression in The Stroke Impact Scale (SIS)	Progression in The Stroke Impact Scale (SIS)	3 months
Secondary	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
Secondary	Brain datas (fMRI activity and CST tractography)	Brain datas (fMRI activity and CST tractography)	28 days