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Neurofeedback for Upper-limb Recovery After Stroke

NCT ID: NCT03766113

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2022-07-28

Brief Summary

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

Detailed Description

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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.

Conditions

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Stroke

Keywords

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Neurofeedback ; fMRI ; EEG ; BCI ; Motor imagery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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Healthy volunteer

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

Group Type OTHER

Neurofeedback coupling electroencephalogram and functional MRI in time actual

Intervention Type OTHER

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

Patients at the early stage after stroke

* 30 subjects
* Effectiveness of an electroencephalogram-neurofeedback

Group Type OTHER

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

Intervention Type OTHER

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.

Patients at the chronic stage after stroke

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

Group Type OTHER

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

Intervention Type OTHER

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

Interventions

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Neurofeedback coupling electroencephalogram and functional MRI in time actual

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

Intervention Type 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.

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rennes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Simon Butet

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

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Rennes University Hospital

Rennes, , France

Site Status

Countries

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France

Other Identifiers

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35RC18_9813_NeuroFB-AVC

Identifier Type: -

Identifier Source: org_study_id