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HAptic Neurofeedback Design for Stroke (HANDS)

Primary Purpose

Stroke

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Visual virtual Conditions

Standard EEG

Neurofeedback Training Stroke Patients

About this trial

This is an interventional other trial for Stroke focused on measuring stroke, neurofeedback, tendon vibration, virtual reality, haptic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Rennes University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

TEST 1: Visual virtual Conditions

TEST 2: Standard EEG

TEST 3: Neurofeedback Training Stroke Patients

Arm Description

50 subjects (30 healthy volunteers and 20 patients after stroke) 3 different situations of vibration applications, without EGG neurofeedback session

20 subjects (healthy volunteers) 3 separate electroencephalographic recording conditions without Neurofeedback

26 patients after stroke 12 neurofeedback sessions spread over 6 weeks according to the feedback modality that will be drawn (visual or visuo-vibratory)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04130711

First Posted

October 14, 2019

Last Updated

June 8, 2023

Sponsor

Rennes University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04130711

Brief Title

HAptic Neurofeedback Design for Stroke

Acronym

HANDS

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

October 23, 2019 (Actual)

Primary Completion Date

April 28, 2023 (Actual)

Study Completion Date

April 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

stroke, neurofeedback, tendon vibration, virtual reality, haptic

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TEST 1: Visual virtual Conditions

Arm Type

Other

Arm Description

50 subjects (30 healthy volunteers and 20 patients after stroke) 3 different situations of vibration applications, without EGG neurofeedback session

Arm Title

TEST 2: Standard EEG

Arm Type

Other

Arm Description

20 subjects (healthy volunteers) 3 separate electroencephalographic recording conditions without Neurofeedback

Arm Title

TEST 3: Neurofeedback Training Stroke Patients

Arm Type

Other

Arm Description

26 patients after stroke 12 neurofeedback sessions spread over 6 weeks according to the feedback modality that will be drawn (visual or visuo-vibratory)

Intervention Type

Other

Intervention Name(s)

Visual virtual Conditions

Other Intervention Name(s)

3 different situations of vibration applications, without EGG neurofeedback session

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Standard EEG

Other Intervention Name(s)

3 separate electroencephalographic recording conditions without Neurofeedback

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Neurofeedback Training Stroke Patients

Other Intervention Name(s)

12 neurofeedback sessions spread over 6 weeks according to the feedback modality that will be drawn (visual or visuo-vibratory)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Relative Power of Event Related Desynchronization in µ et beta EEG bands of healthy controls and stroke participants

Description

Time Frame

throught study completion, in the 5th week after the onset of the experiment for each participant

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mélanie COGNE

Organizational Affiliation

Rennes University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rennes University Hospital

City

Rennes

ZIP/Postal Code

35033

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

34717672

Citation

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.

Results Reference

derived

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HAptic Neurofeedback Design for Stroke

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