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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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)

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)

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

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)

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.

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).

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"

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)

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)

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"

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"

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

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).

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)

Study 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.

Eligibility

Primary outcome measure(s)

• The delta Δ measured (post- versus pre-training) by the Fugl-Meyer test of the upper limb between the 2 groups — 18 months
  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).

Trial sites (1)

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