Neurofeedback for Upper-limb Recovery After Stroke

Not Applicable

Terminated

• Conditions: Stroke
• Interventions: Other: Neurofeedback coupling electroencephalogram and functional MRI in time actual; Other: Electroencephalogram-neurofeedback program or Neurofeedback-free mental imaging program with electroencephalogram recording; Other: Neurofeedback coupling electroencephalogram and functional MRI in time actual or a neurofeedback-free mental imaging program with electroencephalogram recording

• Registration Number: NCT03766113
• Lead Sponsor: Rennes University Hospital

Brief Summary

Interventional study with minimal risks and constraints, prospective, monocentric.

Detailed Description

Neurofeedback (NF) consists on training self-regulation of brain activity by providing real-time information about the participant brain function NF approaches in stroke are usually based on real-time monitoring of brain activity using EEG-NF and involve chronic stroke. Recent studies have revealed the potential of combining EEG and fMRI to achieve a more efficient and specific self-regulation, which may be critical in clinical applications.

The aim of this study is to optimize the neurofeedback method coupling EEG and fMRI in healthy subjects then to evaluate the effect of an EEG-NF and a neurofeedback coupling EEG and fMRI versus motor imagery on recovery in the early and chronic stage after stroke.

Study Timeline

• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-06
• Study Start: 2018-12-20
• Primary Completion: 2022-07-28
• Study Completion: 2022-07-28
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-08
• Last Update Posted: 2022-12-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Patients at the early stage after stroke : Ischemic or hemorrhagic unilateral stroke ; adult (age greater than or equal to 18 years) under 80, of both sexes ; stroke less than 1 month old ; upper limb deficit defined by a SAFE score <8 (SAFE Stinear protocol) at D3 of stroke; absence of comprehension difficulties limiting participation ; with or without homonymous lateral hemianopia ; with or without visuospatial henegligence ; free, informed and written consent signed by the patient or a member of his entourage (in the case of a patient able to understand the information and to express his / her consent but presenting motor difficulties leading to an invalid signature).
• Patients at the chronic stage after stroke : Ischemic or unilateral supra-tentorial unilateral cerebral hemorrhage ; adult (age greater than or equal to 18 years) under 80, of both sexes ; stroke more than 6 months ; motor abilities of the upper limb defines as "poor" to "noticeable" according to Hoonhorst on the Fugl-Meyer upper limb scale, ranging between 22 and 53 out of 66 ; absence of comprehension difficulties limiting participation ; with or without homonymous lateral hemianopia ; with or without visuospatial henegligence ; free, informed and written consent signed by the patient or a member of his entourage (in the case of a patient able to understand the information and to express his / her consent but presenting motor difficulties leading to an invalid signature).
• Healthy Volunteers : Adult (age greater than or equal to 18 years) under 80, of both sexes ; Free, informed and written consent signed by the volunteer.

Exclusion Criteria

• Patients at the early stage after stroke : Ischemic or haemorrhagic involvement of the brainstem ; multiple stroke ; aphasia with major comprehension disorder ; major persons subject to legal protection, persons deprived of their liberty.
• Patients at the chronic stage after stroke : Ischemic or haemorrhagic involvement of the brainstem ; multiple stroke ; aphasia with major comprehension disorder ; vascular leukopathy important to MRI (Fazekas 3) in order not to interfere with the interpretation of MRI ; contraindication to MRI ; major persons subject to legal protection, persons deprived of their liberty.
• Healthy Volunteers : Contraindication to MRI ; pregnancy ; breastfeeding ; major persons subject to legal protection, persons deprived of their liberty

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Healthy volunteer	Neurofeedback coupling electroencephalogram and functional MRI in time actual	* 50 subjects * A single neurofeedback coupling electroencephalogram and functional MRI in time actual .
Patients at the early stage after stroke	Electroencephalogram-neurofeedback program or Neurofeedback-free mental imaging program with electroencephalogram recording	* 30 subjects * Effectiveness of an electroencephalogram-neurofeedback
Patients at the chronic stage after stroke	Neurofeedback coupling electroencephalogram and functional MRI in time actual or a neurofeedback-free mental imaging program with electroencephalogram recording	* 36 subjects * Effectiveness of a neurofeedback coupling electroencephalogram and functional MRI in time actual

Primary Outcome Measures

Name	Time	Method
CXa: Active range of motion at elbow and wirst (from Tardieu scale)	Change in Cxa between baseline and the end of the study

Trial Locations

Locations (1)

Rennes University Hospital; 🇫🇷 Rennes, France