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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01150-45 | Registry Identifier | IDRCB |
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| Name | Class |
|---|---|
| Fondation de l'Avenir | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional group | Experimental | electroencephalographic neurofeedback + traditional reference rehabilitation programme |
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| Control group | Sham Comparator | SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| electroencephalographic neurofeedback | Other | 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).
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| 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 |
| 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 |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LOÏC JACOB | Contact | 0299282555 | loic.jacob@chu-rennes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Simon BUTET, MD | Rennes CHU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rennes Chu | Recruiting | Rennes | 35000 | France |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083302 | Hemorrhagic Stroke |
| D000083242 | Ischemic Stroke |
| D020520 | Brain Infarction |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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
|
| SHAM electroencephalographic neurofeedback | Other | 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).
|
|
| 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 |
| 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 | 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. | 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 | 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. | 3 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |