Cerebrovascular AccidentNCT06212219
Neurofeedback-EEG Rehabilitation Protocol on Motor Recovery in the Subacute Phase Post-stroke (CUSTOM-NF-STROKE)
A study testing Neurofeedback procedure, Fugl-Meyer test and Intrinsic Motivation Inventory questionnaire in people with Cerebrovascular Accident, run by University Hospital, Toulouse at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Neurofeedback procedure, Fugl-Meyer test and Intrinsic Motivation Inventory questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de TOULOUSE
Toulouse, 31000
David GASQ, 5 61 32 28 42 ext. 33, gasq.d@chu-toulouse.fr
Audrey TOMASIK, 5 61 77 85 97 ext. +33, tomasik.a@chu-toulouse.fr
About this study
Official title: Impact of Personalization of a Neurofeedback-EEG Rehabilitation Protocol on Motor Recovery in the Subacute Phase Post-stroke (CUSTOM-NF-STROKE)
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.
Read the 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
- Being tested
- Neurofeedback procedure, Fugl-Meyer test, Intrinsic Motivation Inventory questionnaire, Hospital Anxiety and Depression Scale, State Anxiety Inventory scores
- Keywords
- Neurofeedback
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurofeedback procedureBehavioural
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 testOther
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 questionnaireOther
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 ScaleOther
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 scoresOther
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)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.
System Usability Scale questionnaireOther
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 questionnaireOther
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 testOther
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 QuestionnaireOther
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 QuestionnaireOther
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 SCALEOther
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)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
Feeling VAS scoresOther
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 ScaleOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18 months
Secondary outcomes (14)
Delta Δ (post- versus pre-training) on the Intrinsic Motivation Inventory questionnaire compared between the 2 groups.
Delta Δ (post- versus pre-training) on the Intrinsic Motivation Inventory questionnaire compared between the 2 groups.
Measured: 18 months
Delta Δ (post- and pre-training) in the acceptability questionnaire (BCI-ACCEPT) compared between the 2 groups.
Delta Δ (post- and pre-training) in the acceptability questionnaire (BCI-ACCEPT) compared between the 2 groups.
Measured: 18 months
The difference in the scores of the two groups on the System Usability Scale (SUS) questionnaire post-training.
The difference in the scores of the two groups on the System Usability Scale (SUS) questionnaire post-training.
Measured: 18 months
Evolution of NASA-TLX questionnaire scores during the sessions, for both groups.
Comparison of NASA-TLX questionnaire scores during the sessions, for the two groups.
Measured: 18 months
Evolution of feeling VAS scores at each session, for both groups
Evolution of feeling VAS scores at each session, for both groups
Measured: 18 months
Evolution of scores and Positive and Negative Affects questionnaire, at each session, for both groups.
Evolution of scores and Positive and Negative Affects questionnaire, at each session, for both groups.
Measured: 18 months
Difference in pre-training mental imagery ability scores with the Kinesthetic and Visual Imagery Questionnaire for the two groups
Difference in pre-training mental imagery ability scores with the Kinesthetic and Visual Imagery Questionnaire for the two groups
Measured: 18 months
Evaluation de la personnalité du patient en pré-entraînement (Questionnaire Big Five)
Assessment of the patient's personality in pre-training (Big Five Questionnaire)
Measured: 18 months
The psychological profiles of patients from the two groups in pre-training: locus of control score (KUT)
The psychological profiles of patients from the two groups in pre-training: locus of control score (KUT)
Measured: 18 months
Pre-training profiles of attentional abilities (Attention test)
Pre-training profiles of attentional abilities (Attention test)
Measured: 18 months
Pre-training agency profiles (Agency Questionnaire)
Pre-training agency profiles (Agency Questionnaire)
Measured: 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.
Delta (post- and pre-training) on the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), compared between the 2 groups.
Measured: 18 months
Observation of State Anxiety Inventory (STAI-Y State) scores during sessions, for both groups.
Observation of State Anxiety Inventory (STAI-Y State) scores during sessions, for both groups.
Measured: 18 months
Delta (post- and pre-workout) changes in speed, accuracy and range of motion using the Reaching Performance Scale
Delta (post- and pre-workout) changes in speed, accuracy and range of motion using the Reaching Performance Scale
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start8 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GASQ David, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212219
- Sponsor's protocol ID
- RC31/22/0477
- Status last verified
- May 2026
- First submitted
- 8 Jan 2024
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Personalization of a Neurofeedback-EEG Rehabilitation Protocol on Motor Recovery in the Subacute Phase Post-stroke (CUSTOM-NF-STROKE)
- ClinicalTrials.gov ID
- NCT06212219
- Acronym / sponsor ID
- RC31/22/0477
- Conditions
- Cerebrovascular Accident
- Keywords
- Neurofeedback
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Neurofeedback Procedure | Active comparator | 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 ScaleThe 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 | Experimental | 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 ScalePersonalized 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback procedurePersonalized 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. | Behavioural | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| Fugl-Meyer test419 / 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| Intrinsic Motivation Inventory questionnaireThis 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| Hospital Anxiety and Depression ScaleThis 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| State Anxiety Inventory scoresThis 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| System Usability Scale questionnaireThis 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| NASA Task Load Index questionnaireThis 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| Agency testQuestionnaire 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| Visual and Kinesthetic Imagery QuestionnaireThe 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| Technology Locus of Control Assessment QuestionnaireThe 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| POSITIVE AFFECTIVITY AND NEGATIVE AFFECTIVITY SCALEThis 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| Feeling VAS scoresThe 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 | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
| Reaching Performance ScaleThis 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) | Other | Personalized Neurofeedback Procedure, Standard Neurofeedback Procedure |
Primary outcome
The delta Δ measured (post- versus pre-training) by the Fugl-Meyer test of the upper limb between the 2 groups
Time frame: 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).
14 secondary outcomes
Delta Δ (post- versus pre-training) on the Intrinsic Motivation Inventory questionnaire compared between the 2 groups.
Time frame: 18 months
Delta Δ (post- and pre-training) in the acceptability questionnaire (BCI-ACCEPT) compared between the 2 groups.
Time frame: 18 months
The difference in the scores of the two groups on the System Usability Scale (SUS) questionnaire post-training.
Time frame: 18 months
Evolution of NASA-TLX questionnaire scores during the sessions, for both groups.
Time frame: 18 months
Evolution of feeling VAS scores at each session, for both groups
Time frame: 18 months
Evolution of scores and Positive and Negative Affects questionnaire, at each session, for both groups.
Time frame: 18 months
Difference in pre-training mental imagery ability scores with the Kinesthetic and Visual Imagery Questionnaire for the two groups
Time frame: 18 months
Evaluation de la personnalité du patient en pré-entraînement (Questionnaire Big Five)
Time frame: 18 months
The psychological profiles of patients from the two groups in pre-training: locus of control score (KUT)
Time frame: 18 months
Pre-training profiles of attentional abilities (Attention test)
Time frame: 18 months
Pre-training agency profiles (Agency Questionnaire)
Time frame: 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.
Time frame: 18 months
Observation of State Anxiety Inventory (STAI-Y State) scores during sessions, for both groups.
Time frame: 18 months
Delta (post- and pre-workout) changes in speed, accuracy and range of motion using the Reaching Performance Scale
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GASQ David, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback procedure, Fugl-Meyer test and Intrinsic Motivation Inventory questionnaire in people with Cerebrovascular Accident, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GASQ David, MD (5 61 32 28 42 ext. +33, gasq.d@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The delta Δ measured (post- versus pre-training) by the Fugl-Meyer test of the upper limb between the 2 groups (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.