HAptic Neurofeedback Design for Stroke
HANDS
Preliminary Study to Evaluate the Effect of an EEG-proprioceptive Neurofeedback on Cortical Excitability and Motor Function of the Upper Limb After Stroke
1 other identifier
interventional
76
1 country
1
Brief Summary
Interventional study with minimal risks and constraints, prospective, monocentric.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started Oct 2019
Longer than P75 for not_applicable stroke
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2019
CompletedFirst Posted
Study publicly available on registry
October 17, 2019
CompletedStudy Start
First participant enrolled
October 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2023
CompletedJune 9, 2023
June 1, 2023
3.5 years
October 14, 2019
June 8, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Relative Power of Event Related Desynchronization in µ et beta EEG bands of healthy controls and stroke participants
The relative increase of Event Related Desynchronization (ERD) relative power sensorimotor rhythms (µ et beta bands) in EEG during the last session of NeuroFeedBack in the motor cortex, between motor imagery and rest, measured in microvolt
throught study completion, in the 5th week after the onset of the experiment for each participant
Study Arms (3)
TEST 1: Visual virtual Conditions
OTHER* 50 subjects (30 healthy volunteers and 20 patients after stroke) * 3 different situations of vibration applications, without EGG neurofeedback session
TEST 2: Standard EEG
OTHER* 20 subjects (healthy volunteers) * 3 separate electroencephalographic recording conditions without Neurofeedback
TEST 3: Neurofeedback Training Stroke Patients
OTHER* 26 patients after stroke * 12 neurofeedback sessions spread over 6 weeks according to the feedback modality that will be drawn (visual or visuo-vibratory)
Interventions
The objective is to evaluate if certain virtual visual conditions can increase the illusion of movement induced by the tendon vibration of the upper limb. Thirty healthy volunteers and 20 post-stroke subjects will test 3 different situations of vibration applications, with no EEG Neurofeedback session. It will be applied to the subject (healthy and post-stroke) according to a randomized order a vibrator for a few minutes on his non-dominant (or deficit) hand hidden from view, with a screen representing a static virtual hand, then a vibrator on his hand hidden with a screen representing an animated virtual hand, then a vibrator on his hand hidden with a screen representing an empty background.
Twenty healthy volunteers test 3 separate electroencephalographic recording conditions without Neurofeedback. It will be applied to the subject an EEG headset recording brain activity during the application of vibration stimulation producing the illusion of movement on the non-dominant hand or during a task Mental imagery of the upper limb, or during the joint application of vibratory stimulation and a mental imaging task on the affected upper limb in a randomized order.
The post-stroke subject is evaluated on clinical tests (FMA, ARAT, MAL, NHPT, Finger Tapping test) during the first visit. Then, he performs 12 sessions of NFB (on his deficit member) lasting 45 minutes, spread over 6 weeks, depending on the feedback modality that has been drawn randomly (visual or visuo-vibratory). A second visit after the first NFB session and a third visit after the last NFB session evaluates the motor skills of the trained upper limb (FMA, ARAT, MAL, NHPT, Finger Tapping test) and a satisfaction questionnaire is given to the subject for evaluate tolerance and satisfaction with the feedback modality assigned. Evaluation of changes of EEG sensorimotor rhythms at the end of the program.
Eligibility Criteria
You may qualify if:
- Healthy Volunteers : Major (age greater than or equal to 18 years) and under 80 years; Free, informed and written consent signed by the volunteer; Absence of clinical neurological antecedents that can interact with the achievement of the motor task or with the EEG signal.
- Patients after stroke : Major (age greater than or equal to 18 years) and under 80 years;Ischemic or unilateral cerebral hemorrhagic hemorrhagic attack;Stroke dating back more than 6 months (considered as a delay where recovery of the upper limb to wait is less with conventional rehabilitation);Mild to severe upper limb deficiency: FMA-EU score ≤ 60; 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).
You may not qualify if:
- Healthy Volunteers : major persons subject to legal protection, persons deprived of their liberty
- Patients after stroke : Ischemic or hemorrhagic involvement of posterior fossa (brainstem, cerebellum);Complete motor deficiency of the upper limb (FMA-UE = 0);Epicritic and proprioceptive anesthesia;Understanding difficulties limiting participation in the study;Major persons subject to legal protection, persons deprived of their liberty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rennes University Hospital
Rennes, 35033, France
Related Publications (1)
Le Franc S, Bonan I, Fleury M, Butet S, Barillot C, Lecuyer A, Cogne M. Visual feedback improves movement illusions induced by tendon vibration after chronic stroke. J Neuroeng Rehabil. 2021 Oct 30;18(1):156. doi: 10.1186/s12984-021-00948-7.
PMID: 34717672DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mélanie COGNE
Rennes University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 14, 2019
First Posted
October 17, 2019
Study Start
October 23, 2019
Primary Completion
April 28, 2023
Study Completion
April 28, 2023
Last Updated
June 9, 2023
Record last verified: 2023-06