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

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ClinicalTrials.gov Identifier: NCT03766113
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Brief Summary:
Interventional study with minimal risks and constraints, prospective, monocentric.

Condition or disease Intervention/treatment Phase
Stroke 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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Effect of Unimodal (EEG) and Bimodal (EEG-fMRI) Neurofeedback on Upper Limb Recovery After Stroke
Actual Study Start Date : December 20, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
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

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.


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





Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 ; right-handed (defined by Edinburgh Lateral Questionnaire) ; 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 ; right-handed (defined by Edinburgh Lateral Questionnaire) ; 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 ; low ability to perform mental imagery evaluated by a MIQ-RS score <4 ; 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; Low ability to perform mental imagery evaluated by a MIQ-RS score <4 ; 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766113


Contacts
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Contact: Simon Butet 2 99 28 42 18 ext +33 simon.butet@chu-rennes.fr
Contact: Isabelle Bonan 2 99 28 42 18 ext +33 isabelle.bonan@chu-rennes.fr

Locations
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France
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Simon Butet    2 99 28 42 18 ext +33    simon.butet@chu-rennes.fr   
Contact: Isabelle Bonan    2 99 28 42 18 ext +33    isabelle.bonan@chu-rennes.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Simon Butet Rennes University Hospital

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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03766113     History of Changes
Other Study ID Numbers: 35RC18_9813_NeuroFB-AVC
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rennes University Hospital:
Neurofeedback ; fMRI ; EEG ; BCI ; Motor imagery

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases