| Registry | NCT05884762, acronym YUWIN-Stroke |
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 40 (Estimated) |
| Sponsor | Rennes University Hospital (Other); collaborators: Fondation de l'Avenir |
| Conditions | Stroke, Stroke Hemorrhagic, Stroke, Ischemic, Stroke Rehabilitation, Brain Infarction |
| Interventions | electroencephalographic neurofeedback, SHAM electroencephalographic neurofeedback (Other) |
| Dates | start 2024-02-20, primary completion 2027-11-01 (estimated), completion 2027-11-01 (estimated), first posted 2023-06-01, last updated 2026-03-03 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Stroke All trials for Stroke Hemorrhagic All trials of electroencephalographic neurofeedback All trials of SHAM electroencephalographic neurofeedback
-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
Expand all sections · Collapse all
+Arms and interventions
| Arm | Type | Interventions | Description |
|---|
| Interventional group | Experimental | Other: electroencephalographic neurofeedback | electroencephalographic neurofeedback + traditional reference rehabilitation programme |
| Control group | Sham comparator | Other: SHAM electroencephalographic neurofeedback | SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme |
- 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).
* 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 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).
* 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
+Outcome measures
Primary outcomes
- 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 outcomes
- 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 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 Action Research Arm Test (ARAT) score [3 months]: 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)
- Changes in force emitted (in kg) during a palmar grip (JAMAR) [3 months]: 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 Evaluation of the Motor activiy Log (MAL) [3 months]: 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 Composite Functional Independence Scale (MIF) [3 months]: Progression in The Composite Functional Independence Scale (MIF)
- 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]: 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.
+Eligibility
Sex: All, ages: 18 Years to 80 Years
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.)
+Locations (1)
| Facility | City | Country | Status |
|---|
| Rennes Chu | Rennes | France | Recruiting |
+Investigators
- Simon BUTET, MD, Principal investigator, Rennes CHU