StrokeYUWIN-StrokeNCT05884762
earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke
A study testing electroencephalographic neurofeedback in people with Stroke and Stroke Hemorrhagic, run by Rennes University Hospital at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Stroke Hemorrhagic, Stroke, Ischemic
- What is being tested?
- electroencephalographic neurofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2024to Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rennes Chu
Rennes, 35000
Simon BUTET, MD, 0299284218, simon.butet@chu-rennes.fr
Simon BUTET, MD
About this study
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
- Being tested
- electroencephalographic neurofeedback, SHAM electroencephalographic neurofeedback
- Keywords
- Stroke, Rehabilitation, neurofeedback, Upper Limb
- Medical subject headings
- Stroke, Hemorrhagic Stroke, Ischemic Stroke, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | electroencephalographic neurofeedback + traditional reference rehabilitation programme Receives: Other: electroencephalographic neurofeedback |
| Control group | Sham comparator | SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme Receives: Other: SHAM electroencephalographic neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
Measured: 28 days
Secondary outcomes (18)
Changes in ACTIVE RANGE OF MOTION (CxA) composite score
Changes in ACTIVE RANGE OF MOTION (CxA) composite score
Measured: 28 days
Changes in ACTIVE RANGE OF MOTION (CxA) composite score
Changes in ACTIVE RANGE OF MOTION (CxA) composite score
Measured: 3 months
Changes in Action Research Arm Test (ARAT) score
Changes in Action Research Arm Test (ARAT) score
Measured: 28 days
Changes in Action Research Arm Test (ARAT) score
Changes in Action Research Arm Test (ARAT) score
Measured: 3 months
Changes in force emitted (in kg) during a palmar grip (JAMAR)
Changes force emitted (in kg) during a palmar grip (JAMAR)
Measured: 28 days
Changes in force emitted (in kg) during a palmar grip (JAMAR)
Changes force emitted (in kg) during a palmar grip (JAMAR)
Measured: 3 months
Progression in Evaluation of the Motor activiy Log (MAL)
Progression in Evaluation of the Motor activiy Log (MAL)
Measured: 28 days
Progression in Evaluation of the Motor activiy Log (MAL)
Progression in Evaluation of the Motor activiy Log (MAL)
Measured: 3 months
Progression in The Composite Functional Independence Scale (MIF)
Progression in The Composite Functional Independence Scale (MIF)
Measured: 28 days
Progression in The Composite Functional Independence Scale (MIF)
Progression in The Composite Functional Independence Scale (MIF)
Measured: 3 months
Progression in The Stroke Impact Scale (SIS)
Progression in The Stroke Impact Scale (SIS)
Measured: 28 days
Progression in The Stroke Impact Scale (SIS)
Progression in The Stroke Impact Scale (SIS)
Measured: 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
Measured: 28 days
Brain datas (fMRI activity and CST tractography)
Brain datas (fMRI activity and CST tractography)
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start20 Feb 2024
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation de l'Avenir
- Responsible party
- Sponsor
- Investigators
- Simon BUTET, MD, Principal investigator, Rennes CHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884762
- Sponsor's protocol ID
- 35RC22_9743_YUWIN-Stroke
- Other IDs
- 2023-A01150-45
- Acronym
- YUWIN-Stroke
- Status last verified
- Feb 2026
- First submitted
- 23 May 2023
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke
- ClinicalTrials.gov ID
- NCT05884762
- Acronym / sponsor ID
- YUWIN-Stroke / 35RC22_9743_YUWIN-Stroke
- Keywords
- Stroke, Rehabilitation, neurofeedback, Upper Limb
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Fondation de l'Avenir
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: electroencephalographic neurofeedbackelectroencephalographic neurofeedback + traditional reference rehabilitation programme |
| Control group | Sham comparator | Other: SHAM electroencephalographic neurofeedbackSHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| electroencephalographic neurofeedbackThe 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. | Other | Interventional group |
| SHAM electroencephalographic neurofeedbackThe 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 | Other | Control group |
Primary outcome
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
Time frame: 28 days
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
18 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)
Time frame: 28 days
Changes in 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)
Time frame: 3 months
Acceptability of overseeing the neurofeedback protocol among healthcare professionals (questionnaires)
Time frame: 3 months
Acceptance of overseeing the neurofeedback protocol among healthcare professionals (semi-open interviews)
Time frame: 3 months
Acceptance of overseeing the neurofeedback protocol among healthcare professionals (questionnaires)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Simon BUTET, MD principal investigator
Rennes CHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electroencephalographic neurofeedback in people with Stroke and Stroke Hemorrhagic, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact LOÏC JACOB (0299282555, loic.jacob@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.