Brain Infarction, Stroke, Stroke Hemorrhagic, Stroke, Ischemic, Stroke Rehabilitation
Conditions
Keywords
Stroke, Rehabilitation, neurofeedback, Upper Limb
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
Interventions
OTHERelectroencephalographic 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.
OTHERSHAM 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
Sponsors
Rennes University Hospital
Fondation de l'Avenir
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The occupational therapist who will include and do the sessions will be open. The assessors who will test motor functions during the assessments will be blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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 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
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. (Patients who have undergone thrombolysis or thrombectomy may be included in the study.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity | 28 days | Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in ACTIVE RANGE OF MOTION (CxA) composite score | 28 days | Changes in ACTIVE RANGE OF MOTION (CxA) composite score |
| Changes in Action Research Arm Test (ARAT) score | 28 days | Changes in Action Research Arm Test (ARAT) score |
| Changes in force emitted (in kg) during a palmar grip (JAMAR) | 28 days | Changes force emitted (in kg) during a palmar grip (JAMAR) |
| Progression in Evaluation of the Motor activiy Log (MAL) | 28 days | Progression in Evaluation of the Motor activiy Log (MAL) |
| Progression in The Composite Functional Independence Scale (MIF) | 28 days | Progression in The Composite Functional Independence Scale (MIF) |
| Progression in The Stroke Impact Scale (SIS) | 28 days | Progression in The Stroke Impact Scale (SIS) |
| Brain activity measured by electroencephalogram : improvement in cerebral activations in target zones | 28 days | Brain activity measured by electroencephalogram : improvement in cerebral activations in target zones |
| Brain datas (fMRI activity and CST tractography) | 28 days | Brain datas (fMRI activity and CST tractography) |
| Acceptability of overseeing the neurofeedback protocol among healthcare professionals (semi-open interviews) | 3 months | Assessing the a priori acceptance (acceptability) of overseeing neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by semi-open interviews |
| Acceptability of overseeing the neurofeedback protocol among healthcare professionals (questionnaires) | 3 months | Assessing the a priori acceptance (acceptability) of overseeing the neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by questionnaires. |
| Acceptance of overseeing the neurofeedback protocol among healthcare professionals (semi-open interviews) | 3 months | Assessing the retrospective adoption (acceptance) of overseeing the neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by semi-open interviews |
| Acceptance of overseeing the neurofeedback protocol among healthcare professionals (questionnaires) | 3 months | Assessing the retrospective adoption (acceptance) of overseeing the neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by questionnaires. |
Countries
France
Contacts
CONTACTLOÏC JACOB
PRINCIPAL_INVESTIGATORSimon BUTET, MD
Rennes CHU
Outcome results
None listed