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NCT Number: NCT05884762

earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rennes Chu

Rennes, 35000, France

Location status: Recruiting

Location contact

Simon BUTET, MD

CONTACT

[email protected]

0299284218

Simon BUTET, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

Primary outcomes

  1. 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

Secondary outcomes

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

    Time frame: 28 days

    Changes in ACTIVE RANGE OF MOTION (CxA) composite score

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

    Time frame: 3 months

    Changes in ACTIVE RANGE OF MOTION (CxA) composite score

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

    Time frame: 28 days

    Changes in Action Research Arm Test (ARAT) score

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

    Time frame: 3 months

    Changes in Action Research Arm Test (ARAT) score

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

    Time frame: 28 days

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

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

    Time frame: 3 months

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

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

    Time frame: 28 days

    Progression in Evaluation of the Motor activiy Log (MAL)

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

    Time frame: 3 months

    Progression in Evaluation of the Motor activiy Log (MAL)

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

    Time frame: 28 days

    Progression in The Composite Functional Independence Scale (MIF)

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

    Time frame: 3 months

    Progression in The Composite Functional Independence Scale (MIF)

  11. Progression in The Stroke Impact Scale (SIS)

    Time frame: 28 days

    Progression in The Stroke Impact Scale (SIS)

  12. Progression in The Stroke Impact Scale (SIS)

    Time frame: 3 months

    Progression in The Stroke Impact Scale (SIS)

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

    Time frame: 28 days

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

  14. Brain datas (fMRI activity and CST tractography)

    Time frame: 28 days

    Brain datas (fMRI activity and CST tractography)

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

    Time frame: 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

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

    Time frame: 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.

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

    Time frame: 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

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

LOÏC JACOB

CONTACT

[email protected]

0299282555

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

  • Fondation de l'Avenir

Registry information

Acronym: YUWIN-Stroke

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 1, 2023
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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