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

Primary Purpose

Stroke

Status

Terminated

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Neurofeedback coupling electroencephalogram and functional MRI in time actual

Electroencephalogram-neurofeedback program or Neurofeedback-free mental imaging program with electroencephalogram recording

Neurofeedback coupling electroencephalogram and functional MRI in time actual or a neurofeedback-free mental imaging program with electroencephalogram recording

About this trial

This is an interventional other trial for Stroke focused on measuring Neurofeedback ; fMRI ; EEG ; BCI ; Motor imagery

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rennes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Healthy volunteer

Patients at the early stage after stroke

Patients at the chronic stage after stroke

Arm Description

50 subjects A single neurofeedback coupling electroencephalogram and functional MRI in time actual .

30 subjects Effectiveness of an electroencephalogram-neurofeedback

36 subjects Effectiveness of a neurofeedback coupling electroencephalogram and functional MRI in time actual

Outcomes

Primary Outcome Measures

CXa: Active range of motion at elbow and wirst (from Tardieu scale)

Secondary Outcome Measures

Full Information

NCT ID

NCT03766113

First Posted

November 22, 2018

Last Updated

December 8, 2022

Sponsor

Rennes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03766113

Brief Title

Neurofeedback for Upper-limb Recovery After Stroke

Acronym

NeuroFB-AVC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Terminated

Why Stopped

Recruitment difficulties

Study Start Date

December 20, 2018 (Actual)

Primary Completion Date

July 28, 2022 (Actual)

Study Completion Date

July 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

Neurofeedback ; fMRI ; EEG ; BCI ; Motor imagery

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy volunteer

Arm Type

Other

Arm Description

50 subjects A single neurofeedback coupling electroencephalogram and functional MRI in time actual .

Arm Title

Patients at the early stage after stroke

Arm Type

Other

Arm Description

30 subjects Effectiveness of an electroencephalogram-neurofeedback

Arm Title

Patients at the chronic stage after stroke

Arm Type

Other

Arm Description

36 subjects Effectiveness of a neurofeedback coupling electroencephalogram and functional MRI in time actual

Intervention Type

Other

Intervention Name(s)

Neurofeedback coupling electroencephalogram and functional MRI in time actual

Intervention Description

One visit : Neurofeedback coupling electroencephalogram and functional MRI in time actual

Intervention Type

Other

Intervention Name(s)

Electroencephalogram-neurofeedback program or Neurofeedback-free mental imaging program with electroencephalogram recording

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Neurofeedback coupling electroencephalogram and functional MRI in time actual or a neurofeedback-free mental imaging program with electroencephalogram recording

Intervention Description

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

Primary Outcome Measure Information:

Title

CXa: Active range of motion at elbow and wirst (from Tardieu scale)

Time Frame

Change in Cxa between baseline and the end of the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Simon Butet

Organizational Affiliation

Rennes University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rennes University Hospital

City

Rennes

ZIP/Postal Code

35033

Country

France

12. IPD Sharing Statement

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Neurofeedback for Upper-limb Recovery After Stroke

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