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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Другое 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)
• Другое 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)
• Другое 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
• Другое 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)
• Другое 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.
• Другое 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).
• Другое 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"
• Другое 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)
• Другое 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)

Первичные конечные точки

• The delta Δ measured (post- versus pre-training) by the Fugl-Meyer test of the upper limb between the 2 groups [Срок оценки: 18 months]

Вторичные конечные точки (12)

• Delta Δ (post- versus pre-training) on the Intrinsic Motivation Inventory questionnaire compared between the 2 groups. [Срок оценки: 18 months]
• Delta Δ (post- and pre-training) in the acceptability questionnaire (BCI-ACCEPT) compared between the 2 groups. [Срок оценки: 18 months]
• The difference in the scores of the two groups on the System Usability Scale (SUS) questionnaire post-training. [Срок оценки: 18 months]
• Evolution of NASA-TLX questionnaire scores during the sessions, for both groups. [Срок оценки: 18 months]
• Evolution of feeling VAS scores at each session, for both groups [Срок оценки: 18 months]
• Evolution of scores and Positive and Negative Affects questionnaire, at each session, for both groups. [Срок оценки: 18 months]
• Difference in pre-training mental imagery ability scores with the Kinesthetic and Visual Imagery Questionnaire for the two groups [Срок оценки: 18 months]
• Evaluation de la personnalité du patient en pré-entraînement (Questionnaire Big Five) [Срок оценки: 18 months]
• The psychological profiles of patients from the two groups in pre-training: locus of control score (KUT) [Срок оценки: 18 months]
• Pre-training profiles of attentional abilities (Attention test) [Срок оценки: 18 months]
• Pre-training agency profiles (Agency Questionnaire) [Срок оценки: 18 months]
• Delta (post- and pre-training) on the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), compared between the 2 groups. [Срок оценки: 18 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 1 центр

• CHU de TOULOUSE — Toulouse

Идентификаторы

NCT: NCT06212219 · RC31/22/0477

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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