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

NCT06212219 | Unknown

• 1 other identifier: RC31/22/0477
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebrovascular Accident

Keywords

Neurofeedback

Outcome Measures

Primary Outcomes (1)

• The delta Δ measured (post- versus pre-training) by the Fugl-Meyer test of the upper limb between the 2 groups

  Two measurements will be carried out pre- and two measurements post-, making four measurements in total in each group. For pre- and post-comparisons, we will use the averages of these measurements (pre-average vs post-training average), after three weeks of rehabilitation (15 sessions).

  18 months

Secondary Outcomes (14)

• Delta Δ (post- versus pre-training) on the Intrinsic Motivation Inventory questionnaire compared between the 2 groups.

  18 months

• Delta Δ (post- and pre-training) in the acceptability questionnaire (BCI-ACCEPT) compared between the 2 groups.

  18 months

• The difference in the scores of the two groups on the System Usability Scale (SUS) questionnaire post-training.

  18 months

• Evolution of NASA-TLX questionnaire scores during the sessions, for both groups.

  18 months

• Evolution of feeling VAS scores at each session, for both groups

  18 months

Study Arms (2)

Standard Neurofeedback Procedure

ACTIVE COMPARATOR

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.

Behavioral: Neurofeedback procedure; Other: Fugl-Meyer test; Other: Intrinsic Motivation Inventory questionnaire; Other: Hospital Anxiety and Depression Scale; Other: State Anxiety Inventory scores; Other: Acceptability questionnaire (BCI-ACCEPT); Other: System Usability Scale questionnaire; Other: NASA Task Load Index questionnaire; Other: Agency test; Other: Visual and Kinesthetic Imagery Questionnaire; Other: Technology Locus of Control Assessment Questionnaire; Other: POSITIVE AFFECTIVITY AND NEGATIVE AFFECTIVITY SCALE; Other: Self-questionnaire: OCEAN of the five major factors of per- sound (or Big Five model); Other: Feeling VAS scores; Other: Reaching Performance Scale

Personalized Neurofeedback Procedure

EXPERIMENTAL

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.

Behavioral: Neurofeedback procedure; Other: Fugl-Meyer test; Other: Intrinsic Motivation Inventory questionnaire; Other: Hospital Anxiety and Depression Scale; Other: State Anxiety Inventory scores; Other: Acceptability questionnaire (BCI-ACCEPT); Other: System Usability Scale questionnaire; Other: NASA Task Load Index questionnaire; Other: Agency test; Other: Visual and Kinesthetic Imagery Questionnaire; Other: Technology Locus of Control Assessment Questionnaire; Other: POSITIVE AFFECTIVITY AND NEGATIVE AFFECTIVITY SCALE; Other: Self-questionnaire: OCEAN of the five major factors of per- sound (or Big Five model); Other: Feeling VAS scores; Other: Reaching Performance Scale

Interventions

Neurofeedback procedure 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.

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

Fugl-Meyer test 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)

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

Intrinsic Motivation Inventory questionnaire 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)

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

Hospital Anxiety and Depression Scale 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

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

State Anxiety Inventory scores 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)

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

Acceptability questionnaire (BCI-ACCEPT) 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.

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

System Usability Scale questionnaire 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).

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

NASA Task Load Index questionnaire 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"

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

Agency test 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)

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

Visual and Kinesthetic Imagery Questionnaire 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)

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

Technology Locus of Control Assessment Questionnaire 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"

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

POSITIVE AFFECTIVITY AND NEGATIVE AFFECTIVITY SCALE 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"

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

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

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

Feeling VAS scores 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).

Personalized Neurofeedback Procedure; Standard Neurofeedback Procedure

Reaching Performance Scale 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; Standard Neurofeedback Procedure

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

CHU de TOULOUSE

Toulouse, 31000, France

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

4-amino-4'-hydroxylaminodiphenylsulfone

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• GASQ David, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

GASQ David, MD

CONTACT

5 61 32 28 42; gasq.d@chu-toulouse.fr

TOMASIK Audrey

CONTACT

5 61 77 85 97; tomasik.a@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 18, 2024
• Study Start: January 8, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)