NCT06212219

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
OTHER	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)
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)
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
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)
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.
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).
OTHER	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"
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)
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)
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"
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"
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
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).
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)

Timeline

• Start date: 2024-01-08
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-01-18
• Last updated: 2024-01-18

Locations

1 site across 1 country: France