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Recruiting NCT05884762

earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

No phase Interventional Stroke Stroke Hemorrhagic Stroke, Ischemic Stroke Rehabilitation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: electroencephalographic neurofeedback, SHAM electroencephalographic neurofeedback.
Who it may be relevant to
Registry conditions: Stroke, Stroke Hemorrhagic, Stroke, Ischemic, Stroke Rehabilitation. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

Interventions

  • Other 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 affecte
  • Other SHAM 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 affecte

Primary outcome measures

  • Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity [Time frame: 28 days]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

France · 1 center
  • Rennes Chu — Rennes

Identifiers

NCT: NCT05884762 · 35RC22_9743_YUWIN-Stroke · 2023-A01150-45

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗