earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

Rennes University Hospital40 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Stroke Stroke Hemorrhagic Stroke, Ischemic Stroke Rehabilitation Brain Infarction

electroencephalographic neurofeedbackOTHER

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.

SHAM electroencephalographic neurofeedbackOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

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

Time frame: 28 days

Secondary Outcomes

Changes in ACTIVE RANGE OF MOTION (CxA) composite score

Time frame: 28 days

Changes in ACTIVE RANGE OF MOTION (CxA) composite score

Time frame: 3 months

Changes in Action Research Arm Test (ARAT) score

Time frame: 28 days

Changes in Action Research Arm Test (ARAT) score

Time frame: 3 months

Changes in force emitted (in kg) during a palmar grip (JAMAR)

Changes force emitted (in kg) during a palmar grip (JAMAR)

Time frame: 28 days

Changes in force emitted (in kg) during a palmar grip (JAMAR)

Changes force emitted (in kg) during a palmar grip (JAMAR)

Time frame: 3 months

Progression in Evaluation of the Motor activiy Log (MAL)

Time frame: 28 days

Progression in Evaluation of the Motor activiy Log (MAL)

Time frame: 3 months

Progression in The Composite Functional Independence Scale (MIF)

Time frame: 28 days

Progression in The Composite Functional Independence Scale (MIF)

Time frame: 3 months

Progression in The Stroke Impact Scale (SIS)

Time frame: 28 days

Progression in The Stroke Impact Scale (SIS)

Time frame: 3 months

Brain activity measured by electroencephalogram : improvement in cerebral activations in target zones

Time frame: 28 days

Brain datas (fMRI activity and CST tractography)

Time frame: 28 days

Acceptability of overseeing the neurofeedback protocol among healthcare professionals (semi-open interviews)

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

Time frame: 3 months

Acceptability of overseeing the neurofeedback protocol among healthcare professionals (questionnaires)

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.

Time frame: 3 months

Acceptance of overseeing the neurofeedback protocol among healthcare professionals (semi-open interviews)

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

Time frame: 3 months

Acceptance of overseeing the neurofeedback protocol among healthcare professionals (questionnaires)

Assessing the retrospective adoption (acceptance) of overseeing the neurofeedback protocol among healthcare professionals involved in the care of post-stroke patients, measured by questionnaires.

Time frame: 3 months

earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts