HAptic Neurofeedback Design for Stroke

Overview

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

Full Title of Study: “Preliminary Study to Evaluate the Effect of an EEG-proprioceptive Neurofeedback on Cortical Excitability and Motor Function of the Upper Limb After Stroke”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2021

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.

Interventions

  • 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: Standard EEG
    • In this phase of Test 2 in post-stroke subjects, the aim is to study the modification of the cortical excitability related to simple vibration stimulation, in subjects with supra-tentorial vascular cerebral lesions. For this step, we broaden the criteria for inclusion of post-stroke subjects. Twenty healthy volunteers and 20 post-stroke subjects test 3 separate electroencephalographic recording conditions without Neurofeedback. It will be applied to the subject (healthy and post-stroke) an EEG headset recording brain activity during the application of vibration stimulation producing the illusion of movement on the non-dominant hand (or deficit), 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: Neurofeedback Trial
    • Twenty-one healthy volunteers participate in the study. The healthy subject performs a session of Neurofeedback (on the non-dominant limb) of 30 minutes, trying in a random order the 3 modalities of feedback for 10 minutes each (visual, vibratory, visual combination + vibratory). The subject evaluates by a satisfaction questionnaire immediately after the session the tolerance of each modality and its possible preference. An analysis of the recorded EEG signals will then be performed.
  • Other: Neurofeedback Training Healthy subjects
    • Twenty-one healthy volunteers participate in the study. The healthy subject is evaluated on the Finger Tapping test and the NHPT to assess the motor skills of his 2 upper limbs. Then he performs 6 sessions of Neurofeedback (on the non-dominant limb) lasting 45 minutes each, spread over 2 weeks, according to the feedback modality that has been drawn randomly (visual, vibratory, visual combination + vibratory). A second visit after the first session of NFB and a third visit after the last session of NFB evaluates the motor skills of the 2 upper limbs (Finger Tapping test, NHPT) and a satisfaction questionnaire is given to the subject to assess tolerance and satisfaction compared to the feedback mode assigned. Evaluation of changes of EEG sensorimotor rhythms at the end of the program.
  • 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 15 sessions of NFB (on his deficit member) lasting 45 minutes, spread over 5 weeks, depending on the feedback modality that has been drawn randomly (visual or 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.

Arms, Groups and Cohorts

  • Other: 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: TEST 2: Standard EEG
    • 40 subjects (20 healthy volunteers and 20 patients after stroke) 3 separate electroencephalographic recording conditions without Neurofeedback
  • Other: TEST 3: Neurofeedback Trial
    • 21 healthy volunteers 3 modalities of feedback during 10 minutes each (visual, vibratory, visual combination + vibratory)
  • Other: TEST 4: Neurofeedback Training Healthy subjects
    • 21 healthy volunteers 6 neurofeedback sessions spread over 2 weeks according to the feedback modality that will be drawn (visual, vibratory, visual combination + vibratory)
  • Other: TEST 5: Neurofeedback Training Stroke Patients
    • 20 patients after stroke 15 neurofeedback sessions spread over 5 weeks according to the feedback modality that will be drawn (visual or vibratory)

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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).
  • Patients after stroke (Test 2) : 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 48 hours;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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Rennes University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mélanie COGNE, Principal Investigator, Rennes University Hospital
  • Overall Contact(s)
    • Mélanie COGNE, 299284218, melanie.cogne@chu-rennes.fr

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