earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

Not Applicable

Recruiting

• Conditions: Stroke Rehabilitation; Stroke, Ischemic; Brain Infarction; Stroke Hemorrhagic; Stroke
• Interventions: Other: SHAM electroencephalographic neurofeedback; Other: electroencephalographic neurofeedback

• Registration Number: NCT05884762
• Lead Sponsor: Rennes University Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-01
• Status Verified: 2024-02
• Study Start: 2024-02-20
• Last Update Submitted: 2024-02-21
• Last Update Posted: 2024-02-23
• Primary Completion: 2025-09-20
• Study Completion: 2026-01-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	SHAM electroencephalographic neurofeedback	SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme
Interventional group	electroencephalographic neurofeedback	electroencephalographic neurofeedback + traditional reference rehabilitation programme

Primary Outcome Measures

Name	Time	Method
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity	28 days	Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity

Secondary Outcome Measures

Name	Time	Method
Progression in The Stroke Impact Scale (SIS)	3 months	Progression in The Stroke Impact Scale (SIS)
Brain datas (fMRI activity and CST tractography)	28 days	Brain datas (fMRI activity and CST tractography)
Changes in Action Research Arm Test (ARAT) score	3 months	Changes in Action Research Arm Test (ARAT) score
Progression in The Composite Functional Independence Scale (MIF)	3 months	Progression in The Composite Functional Independence Scale (MIF)
Progression in Evaluation of the Motor activiy Log (MAL)	3 months	Progression in Evaluation of the Motor activiy Log (MAL)
Brain activity measured by electroencephalogram : improvement in cerebral activations in target zones	28 days	Brain activity measured by electroencephalogram : improvement in cerebral activations in target zones
Changes in force emitted (in kg) during a palmar grip (JAMAR)	3 months	Changes force emitted (in kg) during a palmar grip (JAMAR)
Changes in ACTIVE RANGE OF MOTION (CxA) composite score	3 months	Changes in ACTIVE RANGE OF MOTION (CxA) composite score

Trial Locations

Locations (1)

Rennes Chu; 🇫🇷 Rennes, France