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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
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: Visual virtual Conditions Other: Standard EEG Other: Neurofeedback Training Stroke Patients Not Applicable

Detailed Description:
Many patients with stroke have a severe motor deficit in the upper limb impacting their independence. Electroencephalogram (EEG) Neurofeedback is a re-education technique that improves cerebral plasticity and motor gain in these people during the chronic phase of stroke. The visual feedback usually used tends to diminish the subject's attentional resources, while the proprioceptive feedbacks appear to be more effective on cortical excitability. Vibration feedback inducing movement illusion has been shown to be effective in healthy subjects, but has not been tested in people with stroke.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Arm Intervention/treatment
TEST 1: Visual virtual Conditions
  • 50 subjects (30 healthy volunteers and 20 patients after stroke)
  • 3 different situations of vibration applications, without EGG neurofeedback session
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
  • 20 subjects (healthy volunteers)
  • 3 separate electroencephalographic recording conditions without Neurofeedback
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
  • 26 patients after stroke
  • 12 neurofeedback sessions spread over 6 weeks according to the feedback modality that will be drawn (visual or visuo-vibratory)
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)




Primary Outcome Measures :
  1. 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



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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:

  • 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).

Exclusion Criteria:

  • 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

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): NCT04130711


Contacts
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Contact: Mélanie COGNE 299284218 ext +33 melanie.cogne@chu-rennes.fr
Contact: Salomé LE FRANC salome.le.franc@hotmail.fr

Locations
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France
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Mélanie COGNE    299284218 ext +33    melanie.cogne@chu-rennes.fr   
Contact: Salomé LE FRANC       salome.le.franc@hotmail.fr   
Sponsors and Collaborators
Rennes University Hospital
Investigators
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Principal Investigator: Mélanie COGNE Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04130711    
Other Study ID Numbers: 35RC19_8866_HANDS
First Posted: October 17, 2019    Key Record Dates
Last Update Posted: March 5, 2021
Last Verified: March 2021

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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:
stroke
neurofeedback
tendon vibration
virtual reality
haptic
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases