Stroke Clinical Trial
— YUWIN-StrokeOfficial title:
earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After 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
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. |
Country | Name | City | State |
---|---|---|---|
France | Rennes Chu | Rennes |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital | Fondation de l'Avenir |
France,
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 |
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