Neurofeedback for Upper-limb Recovery After Stroke (NeuroFB-AVC)

Effect of Unimodal (EEG) and Bimodal (EEG-fMRI) Neurofeedback on Upper Limb Recovery After Stroke

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

Study Overview

• Status: Terminated
• Conditions: Stroke
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35033
    • Rennes University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Healthy volunteer; 50 subjects; A single neurofeedback coupling electroencephalogram and functional MRI in time actual .	Other: Neurofeedback coupling electroencephalogram and functional MRI in time actual; One visit : Neurofeedback coupling electroencephalogram and functional MRI in time actual
Other: Patients at the early stage after stroke; 30 subjects; Effectiveness of an electroencephalogram-neurofeedback	Other: Electroencephalogram-neurofeedback program or Neurofeedback-free mental imaging program with electroencephalogram recording; Interventional group (Electroencephalogram-neurofeedback program) : 24 minutes, 3 times a week for 12 weeks in addition to the traditional rehabilitation program. Controle Group (Neurofeedback-free mental imaging) : 24 minutes, 3 times a week for 12 weeks in addition to the traditional rehabilitation program of reference.
Other: Patients at the chronic stage after stroke; 36 subjects; Effectiveness of a neurofeedback coupling electroencephalogram and functional MRI in time actual	Other: Neurofeedback coupling electroencephalogram and functional MRI in time actual or a neurofeedback-free mental imaging program with electroencephalogram recording; Interventional group (5 weeks) : 5 sessions of neurofeedback coupling electroencephalogram and functional MRI in time actual and 9 sessions of electroencephalogram-neurofeedback program Controle Group (5 weeks) : 14 sessions of neurofeedback-free mental imaging program

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Principal Investigator: Simon Butet, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2018
• Primary Completion (Actual): July 28, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: November 22, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (Actual): December 6, 2018

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 8, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Neurofeedback ; fMRI ; EEG ; BCI ; Motor imagery
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 35RC18_9813_NeuroFB-AVC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No