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RecruitingNCT05884762YUWIN-StrokeUpdated Mar 3, 2026

earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

An interventional study of electroencephalographic neurofeedback and SHAM electroencephalographic neurofeedback in Stroke, Stroke Hemorrhagic and Stroke, Ischemic, sponsored by Rennes University Hospital. Recruiting at 1 site in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Rennes University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

02

Conditions studied

  • Stroke
  • Stroke Hemorrhagic
  • Stroke, Ischemic
  • Stroke Rehabilitation
  • Brain Infarction

Keywords

  • Stroke
  • Rehabilitation
  • neurofeedback
  • Upper Limb
03

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's planned enrollment of 40 is below the median of 49 across 6,024 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.

Browse Rennes University Hospital studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

  • 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.)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Interventional group

    electroencephalographic neurofeedback + traditional reference rehabilitation programme

    Other: electroencephalographic neurofeedback

  • Sham comparator
    Control group

    SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme

    Other: SHAM electroencephalographic neurofeedback

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

06

What researchers measure

Primary outcomes

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

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

    Time frame: 28 days

Secondary outcomes

  1. Changes in ACTIVE RANGE OF MOTION (CxA) composite score

    Changes in ACTIVE RANGE OF MOTION (CxA) composite score

    Time frame: 28 days

  2. Changes in ACTIVE RANGE OF MOTION (CxA) composite score

    Changes in ACTIVE RANGE OF MOTION (CxA) composite score

    Time frame: 3 months

  3. Changes in Action Research Arm Test (ARAT) score

    Changes in Action Research Arm Test (ARAT) score

    Time frame: 28 days

  4. Changes in Action Research Arm Test (ARAT) score

    Changes in Action Research Arm Test (ARAT) score

    Time frame: 3 months

  5. 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

  6. 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

  7. Progression in Evaluation of the Motor activiy Log (MAL)

    Progression in Evaluation of the Motor activiy Log (MAL)

    Time frame: 28 days

  8. Progression in Evaluation of the Motor activiy Log (MAL)

    Progression in Evaluation of the Motor activiy Log (MAL)

    Time frame: 3 months

  9. Progression in The Composite Functional Independence Scale (MIF)

    Progression in The Composite Functional Independence Scale (MIF)

    Time frame: 28 days

  10. Progression in The Composite Functional Independence Scale (MIF)

    Progression in The Composite Functional Independence Scale (MIF)

    Time frame: 3 months

  11. Progression in The Stroke Impact Scale (SIS)

    Progression in The Stroke Impact Scale (SIS)

    Time frame: 28 days

  12. Progression in The Stroke Impact Scale (SIS)

    Progression in The Stroke Impact Scale (SIS)

    Time frame: 3 months

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

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

    Time frame: 28 days

  14. Brain datas (fMRI activity and CST tractography)

    Brain datas (fMRI activity and CST tractography)

    Time frame: 28 days

  15. 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

  16. 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

  17. 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

  18. 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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2024 (actual). Primary completion is estimated for Nov 2027, 45 months after the start.

Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 45 months is above that.

Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2023
First posted
Jun 1, 2023
StartActual
Feb 20, 2024
Primary completionEst.
Nov 2027
CompletionEst.
Nov 2027
Last update
Mar 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05884762
Lead sponsor
Rennes University Hospital
Collaborators
Fondation de l'Avenir
Responsible party
Sponsor
First posted
Jun 1, 2023
Start date
Feb 20, 2024
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
Mar 3, 2026

Study contacts

LOÏC JACOB
Contact
loic.jacob@chu-rennes.fr
0299282555
Simon BUTET, MD
principal investigator · Rennes CHU

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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