earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

Study Overview
=================
Brief 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

Official Title
-----------------
earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

Conditions
-----------------
Stroke, Stroke Hemorrhagic, Stroke, Ischemic, Stroke Rehabilitation, Brain Infarction

Intervention / Treatment
-----------------
* Other: electroencephalographic neurofeedback
* Other: SHAM electroencephalographic neurofeedback


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional group<br>electroencephalographic neurofeedback + traditional reference rehabilitation programme | Other: electroencephalographic neurofeedback<br>* 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.<br>|
| Sham Comparator: Control group<br>SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme | Other: SHAM electroencephalographic neurofeedback<br>* 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<br>|

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Rehabilitation, neurofeedback, Upper Limb