Neurofeedback for Upper-limb Recovery After Stroke

NCT03766113 | Terminated

• 1 other identifier: 35RC18_9813_NeuroFB-AVC
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Keywords

Neurofeedback ; fMRI ; EEG ; BCI ; Motor imagery

Outcome Measures

Primary Outcomes (1)

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

  Change in Cxa between baseline and the end of the study

Study Arms (3)

Healthy volunteer

OTHER

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

Other: Neurofeedback coupling electroencephalogram and functional MRI in time actual

Patients at the early stage after stroke

OTHER

* 30 subjects * Effectiveness of an electroencephalogram-neurofeedback

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

Patients at the chronic stage after stroke

OTHER

* 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

Interventions

Neurofeedback coupling electroencephalogram and functional MRI in time actual OTHER

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

Healthy volunteer

Electroencephalogram-neurofeedback program or Neurofeedback-free mental imaging program with electroencephalogram recording 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 early stage after stroke

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

Patients at the chronic stage after stroke

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Simon Butet

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: December 6, 2018
• Study Start: December 20, 2018
• Primary Completion: July 28, 2022
• Study Completion: July 28, 2022
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

FR (1)