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

Rennes University Hospital

Status: Enrolling

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

Treatments: Other: SHAM electroencephalographic neurofeedback; Other: electroencephalographic neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT05884762

35RC22_9743_YUWIN-Stroke

2023-A01150-45 (Registry Identifier)

Details and patient eligibility

About

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

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Interventional group

Experimental group

Description:

electroencephalographic neurofeedback + traditional reference rehabilitation programme

Treatment:

Other: electroencephalographic neurofeedback

Control group

Sham Comparator group

Description:

SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme

Treatment:

Other: SHAM electroencephalographic neurofeedback