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

Not Applicable

Recruiting

• Conditions: Cerebrovascular Accident
• Interventions: 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: Feeling VAS scores; Other: Reaching Performance Scale

• Registration Number: NCT06212219
• Lead Sponsor: University Hospital, Toulouse

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.

Study Timeline

• Status Verified: 2024-01
• Study Start: 2024-01-08
• Study First Submitted: 2024-01-08
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Neurofeedback Procedure	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.
Standard Neurofeedback Procedure	Intrinsic Motivation Inventory questionnaire	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.
Standard Neurofeedback Procedure	Hospital Anxiety and Depression Scale	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.
Standard Neurofeedback Procedure	Agency test	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.
Standard Neurofeedback Procedure	Technology Locus of Control Assessment Questionnaire	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.
Standard Neurofeedback Procedure	POSITIVE AFFECTIVITY AND NEGATIVE AFFECTIVITY SCALE	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.
Standard Neurofeedback Procedure	Fugl-Meyer test	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.
Standard Neurofeedback Procedure	State Anxiety Inventory scores	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.
Standard Neurofeedback Procedure	Feeling VAS scores	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.
Personalized Neurofeedback Procedure	Fugl-Meyer test	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.
Standard Neurofeedback Procedure	Acceptability questionnaire (BCI-ACCEPT)	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.
Personalized Neurofeedback Procedure	State Anxiety Inventory scores	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.
Personalized Neurofeedback Procedure	System Usability Scale questionnaire	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.
Personalized Neurofeedback Procedure	Agency test	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.
Personalized Neurofeedback Procedure	Visual and Kinesthetic Imagery Questionnaire	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.
Standard Neurofeedback Procedure	System Usability Scale questionnaire	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.
Standard Neurofeedback Procedure	NASA Task Load Index questionnaire	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.
Personalized Neurofeedback Procedure	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.
Personalized Neurofeedback Procedure	Intrinsic Motivation Inventory questionnaire	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.
Personalized Neurofeedback Procedure	Acceptability questionnaire (BCI-ACCEPT)	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.
Standard Neurofeedback Procedure	Visual and Kinesthetic Imagery Questionnaire	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.
Standard Neurofeedback Procedure	Reaching Performance Scale	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.
Personalized Neurofeedback Procedure	Hospital Anxiety and Depression Scale	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.
Personalized Neurofeedback Procedure	Technology Locus of Control Assessment Questionnaire	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.
Personalized Neurofeedback Procedure	NASA Task Load Index questionnaire	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.
Personalized Neurofeedback Procedure	POSITIVE AFFECTIVITY AND NEGATIVE AFFECTIVITY SCALE	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.
Personalized Neurofeedback Procedure	Feeling VAS scores	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.
Personalized Neurofeedback Procedure	Reaching Performance Scale	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.

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
Evaluation de la personnalité du patient en pré-entraînement (Questionnaire Big Five)	18 months	Assessment of the patient's personality in pre-training (Big Five Questionnaire)
Delta Δ (post- and pre-training) in the acceptability questionnaire (BCI-ACCEPT) compared between the 2 groups.	18 months	Delta Δ (post- and pre-training) in the acceptability questionnaire (BCI-ACCEPT) compared between the 2 groups.
Delta (post- and pre-training) on the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), compared between the 2 groups.	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.
Evolution of feeling VAS scores at each session, for both groups	18 months	Evolution of feeling VAS scores at each session, for both groups
Delta (post- and pre-workout) changes in speed, accuracy and range of motion using the Reaching Performance Scale	18 months	Delta (post- and pre-workout) changes in speed, accuracy and range of motion using the Reaching Performance Scale
Delta Δ (post- versus pre-training) on the Intrinsic Motivation Inventory questionnaire compared between the 2 groups.	18 months	Delta Δ (post- versus pre-training) on the Intrinsic Motivation Inventory questionnaire compared between the 2 groups.
Evolution of scores and Positive and Negative Affects questionnaire, at each session, for both groups.	18 months	Evolution of scores and Positive and Negative Affects questionnaire, at each session, for both groups.
The difference in the scores of the two groups on the System Usability Scale (SUS) questionnaire post-training.	18 months	The difference in the scores of the two groups on the System Usability Scale (SUS) questionnaire post-training.
Evolution of NASA-TLX questionnaire scores during the sessions, for both groups.	18 months	Comparison of NASA-TLX questionnaire scores during the sessions, for the two groups.
Difference in pre-training mental imagery ability scores with the Kinesthetic and Visual Imagery Questionnaire for the two groups	18 months	Difference in pre-training mental imagery ability scores with the Kinesthetic and Visual Imagery Questionnaire for the two groups
Pre-training profiles of attentional abilities (Attention test)	18 months	Pre-training profiles of attentional abilities (Attention test)
The psychological profiles of patients from the two groups in pre-training: locus of control score (KUT)	18 months	The psychological profiles of patients from the two groups in pre-training: locus of control score (KUT)
Pre-training agency profiles (Agency Questionnaire)	18 months	Pre-training agency profiles (Agency Questionnaire)
Observation of State Anxiety Inventory (STAI-Y State) scores during sessions, for both groups.	18 months	Observation of State Anxiety Inventory (STAI-Y State) scores during sessions, for both groups.

Trial Locations

Locations (1)

CHU de TOULOUSE; 🇫🇷 Toulouse, France