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earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke (YUWIN-Stroke)

Primary Purpose

Stroke, Stroke Hemorrhagic, Stroke, Ischemic

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
electroencephalographic neurofeedback
SHAM electroencephalographic neurofeedback
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Rehabilitation, neurofeedback, Upper Limb

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Unilateral ischaemic or haemorrhagic stroke Adult (18-80 years), both sexes Stroke < 3 weeks Upper limb deficit defined by Shoulder Abduction Finger Extension score <5 on day 3 of stroke; i.e., patients predicted to have incomplete recovery No participation-limiting comprehension problems With or without homonymous lateral hemianopia; with or without visuospatial hemineglect Free, informed and written consent signed by the patient or a member of the patient's family (in the case of a patient who is able to understand the information and give consent but has motor difficulties resulting in an invalid signature). Affiliated to french social security Exclusion Criteria: Ischemic or hemorrhagic brain stem and/or cerebellum involvement Multiple strokes Stroke < 1 week; in order not to be deleterious by starting active rehabilitation too early after immediate stroke Aphasia with major comprehension impairment Contraindication to MRI pacemaker or implantable defibrillator, neurosurgical clips, cochlear implants, intra-orbital or encephalic metallic foreign bodies, stents placed less than 4 weeks ago and osteosynthesis devices placed less than 6 weeks ago, claustrophobia.

Sites / Locations

  • Rennes Chu

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Interventional group

Control group

Arm Description

electroencephalographic neurofeedback + traditional reference rehabilitation programme

SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme

Outcomes

Primary Outcome Measures

Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity

Secondary Outcome Measures

Full Information

First Posted
May 23, 2023
Last Updated
May 23, 2023
Sponsor
Rennes University Hospital
Collaborators
Fondation de l'Avenir
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1. Study Identification

Unique Protocol Identification Number
NCT05884762
Brief Title
earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke
Acronym
YUWIN-Stroke
Official Title
earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
February 1, 2025 (Anticipated)
Study Completion Date
February 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital
Collaborators
Fondation de l'Avenir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to evaluate the effect of early rehabilitation treatment by electroencephalographic neurofeedback on upper limb motor function after stroke. Researchers will compare : Interventional group: electroencephalographic neurofeedback + traditional reference rehabilitation programme Control group: SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Stroke Hemorrhagic, Stroke, Ischemic, Stroke Rehabilitation, Brain Infarction
Keywords
Stroke, Rehabilitation, neurofeedback, Upper Limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The occupational therapist who will include and do the sessions will be open. The assessors who will test motor functions during the assessments will be blind
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
electroencephalographic neurofeedback + traditional reference rehabilitation programme
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
SHAM electroencephalographic neurofeedback + traditional reference rehabilitation programme
Intervention Type
Other
Intervention Name(s)
electroencephalographic neurofeedback
Intervention Description
The patient is installed in a quiet, isolated room in the Physical Medicine and Rehabilitation Department. The patient sits comfortably in front of a computer. A nurse or a rehabilitator installs the EEG headset and places gel in the electrodes (x32). Connecting the amplifier and interface. Checking the correct positioning and contact of the electrodes (impedance). Calibration phase at rest. Working phase: the sessions last 24 minutes. The patient will be asked to concentrate on the affected arm, and to imagine a movement of this arm, to feel the sensations, without any real movement of the arm. In the Neurofeedback group, the patient will receive visual feedback of a virtual hand moving on a computer screen in front of him/her, depending on his/her brain activations. He will also receive haptic feedback (vibrations) in the flexor muscles of his wrist.
Intervention Type
Other
Intervention Name(s)
SHAM electroencephalographic neurofeedback
Intervention Description
The patient is installed in a quiet, isolated room in the Physical Medicine and Rehabilitation Department. The patient sits comfortably in front of a computer. A nurse or a rehabilitator installs the EEG headset and places gel in the electrodes (x32). Connecting the amplifier and interface. Checking the correct positioning and contact of the electrodes (impedance). Calibration phase at rest. Working phase: the sessions last 24 minutes. The patient will be asked to concentrate on the affected arm, and to imagine a movement of this arm, to feel the sensations, without any real movement of the arm. In the SHAM group, the visual feedback and haptic feedback are randomly generated
Primary Outcome Measure Information:
Title
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
Description
Measurement of motor impairment by the Fugl-Meyer Assesment - Upper Extremity
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unilateral ischaemic or haemorrhagic stroke Adult (18-80 years), both sexes Stroke < 3 weeks Upper limb deficit defined by Shoulder Abduction Finger Extension score <5 on day 3 of stroke; i.e., patients predicted to have incomplete recovery No participation-limiting comprehension problems With or without homonymous lateral hemianopia; with or without visuospatial hemineglect Free, informed and written consent signed by the patient or a member of the patient's family (in the case of a patient who is able to understand the information and give consent but has motor difficulties resulting in an invalid signature). Affiliated to french social security Exclusion Criteria: Ischemic or hemorrhagic brain stem and/or cerebellum involvement Multiple strokes Stroke < 1 week; in order not to be deleterious by starting active rehabilitation too early after immediate stroke Aphasia with major comprehension impairment Contraindication to MRI pacemaker or implantable defibrillator, neurosurgical clips, cochlear implants, intra-orbital or encephalic metallic foreign bodies, stents placed less than 4 weeks ago and osteosynthesis devices placed less than 6 weeks ago, claustrophobia.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
LOÏC JACOB
Phone
0299282555
Email
loic.jacob@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon BUTET, MD
Organizational Affiliation
Rennes CHU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rennes Chu
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simon BUTET, MD
Phone
0299284218
Email
simon.butet@chu-rennes.fr
First Name & Middle Initial & Last Name & Degree
Simon BUTET, MD

12. IPD Sharing Statement

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earlY Upper Limb Rehabilitation WIth EEG-Neurofeedback After Stroke

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