Clinical trial NCT05884762: earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke
Official title: earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Stroke Hemorrhagic
Stroke, Ischemic
Stroke Rehabilitation
Brain Infarction
Keywords: Stroke
Rehabilitation
neurofeedback
Upper Limb
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
Collaborators: name: Fondation de l'Avenir
First posted: 2023-06-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


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 on day 3 of 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.

Primary outcomes:
measure: Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
timeFrame: 28 days
Secondary outcomes:
measure: Changes in ACTIVE RANGE OF MOTION (CxA) composite score
timeFrame: 28 days
measure: Changes in ACTIVE RANGE OF MOTION (CxA) composite score
timeFrame: 3 months
measure: Changes in Action Research Arm Test (ARAT) score
timeFrame: 28 days
measure: Changes in Action Research Arm Test (ARAT) score
timeFrame: 3 months
measure: Changes in force emitted (in kg) during a palmar grip (JAMAR)
timeFrame: 28 days
measure: Changes in force emitted (in kg) during a palmar grip (JAMAR)
timeFrame: 3 months
measure: Progression in Evaluation of the Motor activiy Log (MAL)
timeFrame: 28 days
measure: Progression in Evaluation of the Motor activiy Log (MAL)
timeFrame: 3 months
measure: Progression in The Composite Functional Independence Scale (MIF)
timeFrame: 28 days
measure: Progression in The Composite Functional Independence Scale (MIF)
timeFrame: 3 months
measure: Progression in The Stroke Impact Scale (SIS)
timeFrame: 28 days
measure: Progression in The Stroke Impact Scale (SIS)
timeFrame: 3 months
measure: Brain activity measured by electroencephalogram : improvement in cerebral activations in target zones
timeFrame: 28 days
measure: Brain datas (fMRI activity and CST tractography)
timeFrame: 28 days
Other outcomes:
Locations:
city: Rennes
country: France
facility: Rennes Chu
Study officials:
affiliation: Rennes CHU
name: Simon BUTET, MD
role: PRINCIPAL_INVESTIGATOR
References: