earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

Rennes University Hospital1 个研究点分布在 1 个国家目标入组 40 人2024年2月20日

适应症Stroke Stroke Hemorrhagic Stroke, Ischemic Stroke Rehabilitation Brain Infarction

干预措施electroencephalographic neurofeedback SHAM electroencephalographic neurofeedback

概览

阶段: 不适用
干预措施: electroencephalographic neurofeedback
疾病 / 适应症: Stroke
发起方: Rennes University Hospital
入组人数: 40
试验地点: 1
主要终点: Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
状态: 招募中
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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

注册库

clinicaltrials.gov

开始日期

2024年2月20日

结束日期

2027年11月1日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

All

研究者

发起方

Rennes University Hospital

责任方

Sponsor

入排标准

入选标准

•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

排除标准

•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,

研究组 & 干预措施

Interventional group

electroencephalographic neurofeedback + traditional reference rehabilitation programme

干预措施: electroencephalographic neurofeedback

Control group

SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme

干预措施: SHAM electroencephalographic neurofeedback

结局指标

主要结局

Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity

时间窗: 28 days

Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity

次要结局

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