HAptic Neurofeedback Design for Stroke

NCT ID: NCT04130711

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-23
• Study Completion Date: 2023-04-28

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: OTHER

Visual virtual Conditions

Intervention Type: OTHER

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.

TEST 2: Standard EEG

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

Group Type: OTHER

Standard EEG

Intervention Type: OTHER

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.

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)

Group Type: OTHER

Neurofeedback Training Stroke Patients

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

3 different situations of vibration applications, without EGG neurofeedback session; 3 separate electroencephalographic recording conditions without Neurofeedback; 12 neurofeedback sessions spread over 6 weeks according to the feedback modality that will be drawn (visual or visuo-vibratory)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mélanie COGNE

Role: PRINCIPAL_INVESTIGATOR

Rennes University Hospital

Locations

Rennes University Hospital

Rennes, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 34717672 (View on PubMed)

Other Identifiers

35RC19_8866_HANDS

Identifier Type: -

Identifier Source: org_study_id