HAptic Neurofeedback Design for Stroke (HANDS)
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|ClinicalTrials.gov Identifier: NCT04130711|
Recruitment Status : Recruiting
First Posted : October 17, 2019
Last Update Posted : March 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Other: Visual virtual Conditions Other: Standard EEG Other: Neurofeedback Training Stroke Patients||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preliminary Study to Evaluate the Effect of an EEG-proprioceptive Neurofeedback on Cortical Excitability and Motor Function of the Upper Limb After Stroke|
|Actual Study Start Date :||October 23, 2019|
|Estimated Primary Completion Date :||October 2021|
|Estimated Study Completion Date :||October 2021|
TEST 1: Visual virtual Conditions
Other: Visual virtual Conditions
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.
Other Name: 3 different situations of vibration applications, without EGG neurofeedback session
TEST 2: Standard EEG
Other: Standard EEG
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.
Other Name: 3 separate electroencephalographic recording conditions without Neurofeedback
TEST 3: Neurofeedback Training Stroke Patients
Other: Neurofeedback Training Stroke Patients
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.
Other Name: 12 neurofeedback sessions spread over 6 weeks according to the feedback modality that will be drawn (visual or visuo-vibratory)
- Relative Power of Event Related Desynchronization in µ et beta EEG bands of healthy controls and stroke participants [ Time Frame: throught study completion, in the 5th week after the onset of the experiment for each participant ]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
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): NCT04130711
|Contact: Mélanie COGNE||299284218 ext +firstname.lastname@example.org|
|Contact: Salomé LE FRANCemail@example.com|
|Principal Investigator:||Mélanie COGNE||Rennes University Hospital|