Neurofeedback-EEG Rehabilitation Protocol on Motor Recovery in the Subacute Phase Post-stroke (CUSTOM-NF-STROKE)

NCT ID: NCT06212219

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-08
• Study Completion Date: 2025-12-31

Brief Summary

Neurofeedback (NF) is a procedure for providing direct sensory feedback (in the form of visual, auditory or tactile stimulation) to a patient about their brain activity when performing a cognitive or motor task. This NF aims to allow the patient to become aware of this brain activity and thus learn to modulate it voluntarily in order to improve the performance obtained on the task.

The aim of the study is to compare a "standard NF" procedure to a "personalized NF" procedure designed to optimize the level of patient acceptability based on the results obtained through these questionnaires.

Detailed Description

A large percentage of patients surviving a cerebrovascular accident (CVA) suffer motor aftereffects, notably loss of mobility of the upper limb, linked to cortical lesions. During motor rehabilitation phases, patients are asked to try to move their arm in order to promote synaptic plasticity phenomena at the cortical level, and thus recover a certain mobility. During these movement attempts, the therapist mobilizes the patient's arm. The major problem with this type of rehabilitation is the lack of temporal coherence between the patient's attempted movement and the mobilization carried out by the therapist. Neurofeedback helps remedy this limitation. Thanks to the measurement of the patient's brain activity, we will be able to i) detect these attempted movements, which manifest themselves through the modulation of specific electroencephalographic (EEG) rhythms at the level of the sensorimotor cortices, and ii) provide feedback (e.g., visual, auditory or tactile) that will be synchronized with the attempted movement. This feedback synchronized with the modulation of brain activity makes it possible to close the sensorimotor loop and thus promote synaptic plasticity and motor recovery. Indeed, learning a motor activity is facilitated, on the one hand, by the repetition or training of this activity and, on the other hand, by having feedback - sensory, motor, or proprioceptive. - on its performance (reinforcement learning; Strehl 2014)1.

Several meta-analyses now show the effectiveness of these approaches based on NF-EEG in terms of motor recovery. Cervera et al. (2018)2, Bai et al. (2020)3, Nojima et al. (2022)4 concluded, for example, an effect size of 0.61 to 0.86 on motor recovery (FMA scores) when comparing the effects of NF training during the subacute phase of stroke, compared to other rehabilitation procedures.

However, NF-EEG remains little used in practice. The team hypothesizes that this low level of translation outside laboratories is partly linked to a low level of acceptability and usability of the NF.

The team first identified the factors influencing this acceptability and usability of post-stroke motor rehabilitation procedures based on NF using questionnaires, both among patients and caregivers.

To meet the objective of the study, the investigative team is focusing on patients undergoing post-stroke rehabilitation who are in the subacute phase (15 days to 6 months after the stroke) because several studies have demonstrated that they This was the most favorable period for motor recovery (Dromerick et al. - 2021, Wahl et al. - 2014)5-6.

Conditions

Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Standard Neurofeedback Procedure

The standard NF (sensory feedback) will consist of motor imagery tasks, that is to say that the patient will have to imagine themselves carrying out movements, without real motor execution.

Two types of movements will be alternately requested: a complete sustained extension of the fingers of the paralyzed hand, a global movement of the arm (e.g. opening of the elbow) of the paralyzed arm.

Group Type: ACTIVE_COMPARATOR

NASA Task Load Index questionnaire

Intervention Type: OTHER

This scale assesses psychological validity from the perspective of mental workload. 6 words are offered to the patient about his mental load and he can respond at least "little" and at maximum "A lot"

Agency test

Intervention Type: OTHER

Questionnaire in which statements referring to the patient's general feeling and/or beliefs are presented. the patient has the choice between completely disagree (minimum) and totally agree (maximum)

Visual and Kinesthetic Imagery Questionnaire

Intervention Type: OTHER

The aim of this questionnaire is to obtain an index of individuals' ability to mentally represent different movements. Different movements to imagine are indicated and the patient responds based on their ability to imagine the movement.

He has the choice between "as clear as a film" (maximum) and "no image" (minimum)

Technology Locus of Control Assessment Questionnaire

Intervention Type: OTHER

The questionnaire focuses on patients' opinions on problems related to the use of technical devices. It presents twelve statements that the patient can affirm or deny, depending on their personal point of view. The patient can respond at least "disagree at all" and at maximum "agree completely"

POSITIVE AFFECTIVITY AND NEGATIVE AFFECTIVITY SCALE

Intervention Type: OTHER

This scale is made up of a list of words that indicate certain emotions or feelings. The patient must carefully read each of these words and spontaneously indicate at what level he feels this way at the time he responds to this scale. To do this, he can answer at least "Very little or not at all" and at maximum "A lot"

Neurofeedback procedure

Intervention Type: BEHAVIORAL

Personalized NF will consist of adding to these motor imagery tasks, personalized aspects depending on the patient's profile, for example in terms of level of support and emotional support (addition of a relaxation exercise using an audio recording at the start of training - and in the middle of training if necessary, adding the presence of a companion is to provide social presence and emotional support, depending on the user's performance and progress.), of the virtual environment.

Fugl-Meyer test

Intervention Type: OTHER

419 / 5 000 Résultats de traduction Résultat de traduction This questionnaire assesses the motor selectivity of the upper limb. Several questions are asked about the movements that the patient can perform and to each question, the patient can answer either 0 (minimum) and 2 (maximum)

Intrinsic Motivation Inventory questionnaire

Intervention Type: OTHER

This psychometric motivation questionnaire offers the patient words representative of their motivation to carry out the neurofeedback session and for each proposition they can respond between rather positive (maximum) or rather negative (minimum)

Hospital Anxiety and Depression Scale

Intervention Type: OTHER

This questionnaire assesses the patient's state of anxiety and depression. Concerning anxiety, to each proposition, the patient can answer a number between 0 at minimum (never/not at all) and 3 at maximum (very often) and about depression, the patient can answer a number between 0 at minimum (often, always) and 3 at maximum (never/not at all) The patient can calculate his score at the end

State Anxiety Inventory scores

Intervention Type: OTHER

This questionnaire measures the patient's anxiety at a given time. It features a number of statements that people have previously used to describe themselves. For each statement, choose a "grade" from 1 (not at all) to 4 (Very much)

Acceptability questionnaire (BCI-ACCEPT)

Intervention Type: OTHER

This questionnaire asks the patient about their level of acceptability of NF training using words representative of their motivation to carry out the neurofeedback session and for each proposal they can respond on their feelings regarding the proposals.

System Usability Scale questionnaire

Intervention Type: OTHER

This questionnaire evaluates the usability of personalized NF procedures compared to standard procedures. To each statement, the patient can respond between a minimum of 1 (strongly disagree) and a maximum of 5 (totally agree).

Self-questionnaire: OCEAN of the five major factors of per- sound (or Big Five model)

Intervention Type: OTHER

The model for measuring personality factors is the Anglo-Saxon model known as the "Big Five" or OCEAN in French. It measures 5 major personality traits: openness to experiences, conscientiousness, extroversion, agreeableness and neuroticism. The OCEAN questionnaire is a self-administered questionnaire to be given to a person who wishes to evaluate themselves. It includes 45 items presented in the table below. For each item, patients have 5 response possibilities numbered from 1 to 5: 1 for "strongly disapproves" and 5 for "strongly approves". The patient can calculate his score at the end

Feeling VAS scores

Intervention Type: OTHER

The EVA scale relates to the patient's personal feelings: perceived difficulty, perceived fatigue, perceived ease of learning, level of embodiment, Relevance, Demonstrability of results, Fun aspect, Benefit/risk ratio, Self-efficacy.

For each statement, the patient can respond on a scale ranging from "strongly disagree" (minimum) to "totally agree" (maximum).

Reaching Performance Scale

Intervention Type: OTHER

This scale analyzes the evolution of speed, precision and range of movement using motion capture tools. For each statement, the patient has a rating between 0 (corresponds to not possible) and 3 (corresponds to entirely possible)

Personalized Neurofeedback Procedure

Personalized NF will consist of adding to these motor imagery tasks, personalized aspects depending on the patient's profile, for example in terms of level of support and emotional support (addition of a relaxation exercise using an audio recording at the start of training - and in the middle of training if necessary, adding the presence of a virtual companion to provide social presence and emotional support, depending on the user's performance and progress) , of the virtual environment.

Group Type: EXPERIMENTAL

NASA Task Load Index questionnaire

Intervention Type: OTHER

This scale assesses psychological validity from the perspective of mental workload. 6 words are offered to the patient about his mental load and he can respond at least "little" and at maximum "A lot"

Agency test

Intervention Type: OTHER

Questionnaire in which statements referring to the patient's general feeling and/or beliefs are presented. the patient has the choice between completely disagree (minimum) and totally agree (maximum)

Visual and Kinesthetic Imagery Questionnaire

Intervention Type: OTHER

The aim of this questionnaire is to obtain an index of individuals' ability to mentally represent different movements. Different movements to imagine are indicated and the patient responds based on their ability to imagine the movement.

He has the choice between "as clear as a film" (maximum) and "no image" (minimum)

Technology Locus of Control Assessment Questionnaire

Intervention Type: OTHER

The questionnaire focuses on patients' opinions on problems related to the use of technical devices. It presents twelve statements that the patient can affirm or deny, depending on their personal point of view. The patient can respond at least "disagree at all" and at maximum "agree completely"

POSITIVE AFFECTIVITY AND NEGATIVE AFFECTIVITY SCALE

Intervention Type: OTHER

This scale is made up of a list of words that indicate certain emotions or feelings. The patient must carefully read each of these words and spontaneously indicate at what level he feels this way at the time he responds to this scale. To do this, he can answer at least "Very little or not at all" and at maximum "A lot"

Neurofeedback procedure

Intervention Type: BEHAVIORAL

Personalized NF will consist of adding to these motor imagery tasks, personalized aspects depending on the patient's profile, for example in terms of level of support and emotional support (addition of a relaxation exercise using an audio recording at the start of training - and in the middle of training if necessary, adding the presence of a companion is to provide social presence and emotional support, depending on the user's performance and progress.), of the virtual environment.

Fugl-Meyer test

Intervention Type: OTHER

419 / 5 000 Résultats de traduction Résultat de traduction This questionnaire assesses the motor selectivity of the upper limb. Several questions are asked about the movements that the patient can perform and to each question, the patient can answer either 0 (minimum) and 2 (maximum)

Intrinsic Motivation Inventory questionnaire

Intervention Type: OTHER

This psychometric motivation questionnaire offers the patient words representative of their motivation to carry out the neurofeedback session and for each proposition they can respond between rather positive (maximum) or rather negative (minimum)

Hospital Anxiety and Depression Scale

Intervention Type: OTHER

This questionnaire assesses the patient's state of anxiety and depression. Concerning anxiety, to each proposition, the patient can answer a number between 0 at minimum (never/not at all) and 3 at maximum (very often) and about depression, the patient can answer a number between 0 at minimum (often, always) and 3 at maximum (never/not at all) The patient can calculate his score at the end

State Anxiety Inventory scores

Intervention Type: OTHER

This questionnaire measures the patient's anxiety at a given time. It features a number of statements that people have previously used to describe themselves. For each statement, choose a "grade" from 1 (not at all) to 4 (Very much)

Acceptability questionnaire (BCI-ACCEPT)

Intervention Type: OTHER

This questionnaire asks the patient about their level of acceptability of NF training using words representative of their motivation to carry out the neurofeedback session and for each proposal they can respond on their feelings regarding the proposals.

System Usability Scale questionnaire

Intervention Type: OTHER

This questionnaire evaluates the usability of personalized NF procedures compared to standard procedures. To each statement, the patient can respond between a minimum of 1 (strongly disagree) and a maximum of 5 (totally agree).

Self-questionnaire: OCEAN of the five major factors of per- sound (or Big Five model)

Intervention Type: OTHER

The model for measuring personality factors is the Anglo-Saxon model known as the "Big Five" or OCEAN in French. It measures 5 major personality traits: openness to experiences, conscientiousness, extroversion, agreeableness and neuroticism. The OCEAN questionnaire is a self-administered questionnaire to be given to a person who wishes to evaluate themselves. It includes 45 items presented in the table below. For each item, patients have 5 response possibilities numbered from 1 to 5: 1 for "strongly disapproves" and 5 for "strongly approves". The patient can calculate his score at the end

Feeling VAS scores

Intervention Type: OTHER

The EVA scale relates to the patient's personal feelings: perceived difficulty, perceived fatigue, perceived ease of learning, level of embodiment, Relevance, Demonstrability of results, Fun aspect, Benefit/risk ratio, Self-efficacy.

For each statement, the patient can respond on a scale ranging from "strongly disagree" (minimum) to "totally agree" (maximum).

Reaching Performance Scale

Intervention Type: OTHER

This scale analyzes the evolution of speed, precision and range of movement using motion capture tools. For each statement, the patient has a rating between 0 (corresponds to not possible) and 3 (corresponds to entirely possible)

Interventions

NASA Task Load Index questionnaire

This scale assesses psychological validity from the perspective of mental workload. 6 words are offered to the patient about his mental load and he can respond at least "little" and at maximum "A lot"

Intervention Type: OTHER

Agency test

Questionnaire in which statements referring to the patient's general feeling and/or beliefs are presented. the patient has the choice between completely disagree (minimum) and totally agree (maximum)

Intervention Type: OTHER

Visual and Kinesthetic Imagery Questionnaire

The aim of this questionnaire is to obtain an index of individuals' ability to mentally represent different movements. Different movements to imagine are indicated and the patient responds based on their ability to imagine the movement.

He has the choice between "as clear as a film" (maximum) and "no image" (minimum)

Intervention Type: OTHER

Technology Locus of Control Assessment Questionnaire

The questionnaire focuses on patients' opinions on problems related to the use of technical devices. It presents twelve statements that the patient can affirm or deny, depending on their personal point of view. The patient can respond at least "disagree at all" and at maximum "agree completely"

Intervention Type: OTHER

POSITIVE AFFECTIVITY AND NEGATIVE AFFECTIVITY SCALE

This scale is made up of a list of words that indicate certain emotions or feelings. The patient must carefully read each of these words and spontaneously indicate at what level he feels this way at the time he responds to this scale. To do this, he can answer at least "Very little or not at all" and at maximum "A lot"

Intervention Type: OTHER

Neurofeedback procedure

Personalized NF will consist of adding to these motor imagery tasks, personalized aspects depending on the patient's profile, for example in terms of level of support and emotional support (addition of a relaxation exercise using an audio recording at the start of training - and in the middle of training if necessary, adding the presence of a companion is to provide social presence and emotional support, depending on the user's performance and progress.), of the virtual environment.

Intervention Type: BEHAVIORAL

Fugl-Meyer test

419 / 5 000 Résultats de traduction Résultat de traduction This questionnaire assesses the motor selectivity of the upper limb. Several questions are asked about the movements that the patient can perform and to each question, the patient can answer either 0 (minimum) and 2 (maximum)

Intervention Type: OTHER

Intrinsic Motivation Inventory questionnaire

This psychometric motivation questionnaire offers the patient words representative of their motivation to carry out the neurofeedback session and for each proposition they can respond between rather positive (maximum) or rather negative (minimum)

Intervention Type: OTHER

Hospital Anxiety and Depression Scale

This questionnaire assesses the patient's state of anxiety and depression. Concerning anxiety, to each proposition, the patient can answer a number between 0 at minimum (never/not at all) and 3 at maximum (very often) and about depression, the patient can answer a number between 0 at minimum (often, always) and 3 at maximum (never/not at all) The patient can calculate his score at the end

Intervention Type: OTHER

State Anxiety Inventory scores

This questionnaire measures the patient's anxiety at a given time. It features a number of statements that people have previously used to describe themselves. For each statement, choose a "grade" from 1 (not at all) to 4 (Very much)

Intervention Type: OTHER

Acceptability questionnaire (BCI-ACCEPT)

This questionnaire asks the patient about their level of acceptability of NF training using words representative of their motivation to carry out the neurofeedback session and for each proposal they can respond on their feelings regarding the proposals.

Intervention Type: OTHER

System Usability Scale questionnaire

This questionnaire evaluates the usability of personalized NF procedures compared to standard procedures. To each statement, the patient can respond between a minimum of 1 (strongly disagree) and a maximum of 5 (totally agree).

Intervention Type: OTHER

Self-questionnaire: OCEAN of the five major factors of per- sound (or Big Five model)

The model for measuring personality factors is the Anglo-Saxon model known as the "Big Five" or OCEAN in French. It measures 5 major personality traits: openness to experiences, conscientiousness, extroversion, agreeableness and neuroticism. The OCEAN questionnaire is a self-administered questionnaire to be given to a person who wishes to evaluate themselves. It includes 45 items presented in the table below. For each item, patients have 5 response possibilities numbered from 1 to 5: 1 for "strongly disapproves" and 5 for "strongly approves". The patient can calculate his score at the end

Intervention Type: OTHER

Feeling VAS scores

The EVA scale relates to the patient's personal feelings: perceived difficulty, perceived fatigue, perceived ease of learning, level of embodiment, Relevance, Demonstrability of results, Fun aspect, Benefit/risk ratio, Self-efficacy.

For each statement, the patient can respond on a scale ranging from "strongly disagree" (minimum) to "totally agree" (maximum).

Intervention Type: OTHER

Reaching Performance Scale

This scale analyzes the evolution of speed, precision and range of movement using motion capture tools. For each statement, the patient has a rating between 0 (corresponds to not possible) and 3 (corresponds to entirely possible)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Man, woman, over 18 years old
• Motor deficit of the upper limb type of hemiplegia, secondary to a hemorrhagic or ischemic stroke authenticated by brain imaging (MRI or CT)
• Post-stroke patients in the subacute phase, between 15 days and 6 months after the stroke
• Correct or corrected vision allowing reading at a distance of 0 to 2m
• Ability to maintain a seated position for 1 hour
• Patient affiliated to a social security scheme or beneficiary of such a scheme
• Informed patient having signed consent

Exclusion Criteria

• Minors (age < 18 years)
• Phasic disorder limiting comprehension corresponding to a Boston Diagnostic Aphasia Examination (BDAE) score < 4
• Attentional disorder not allowing sufficient attention to be maintained for 1 hour
• History of known stroke with motor sequelae.
• Known peripheral neurological pathology affecting the paretic upper limb.
• Other known central neurological pathology
• Factors hindering EEG acquisition (scalp pathology, abnormal cervico-cephalic movements, cranial metal implants)
• Unstabilized epilepsy
• Refusal to participate in the study
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
• Pregnant, parturient, or breastfeeding patient

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GASQ David, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

CHU de TOULOUSE

Toulouse, , France

Site Status: RECRUITING

Countries

France

Central Contacts

GASQ David, MD

Role: CONTACT

gasq.d@chu-toulouse.fr

5 61 32 28 42 ext. +33

TOMASIK Audrey

Role: CONTACT

tomasik.a@chu-toulouse.fr

5 61 77 85 97 ext. +33

Facility Contacts

David GASQ

Role: primary

gasq.d@chu-toulouse.fr

5 61 32 28 42 ext. 33

Audrey TOMASIK

Role: backup

tomasik.a@chu-toulouse.fr

5 61 77 85 97 ext. +33

Other Identifiers

RC31/22/0477

Identifier Type: -

Identifier Source: org_study_id