Cerebrovascular Accident Clinical Trial
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.
Status | Recruiting |
Enrollment | 44 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | CHU de TOULOUSE | Toulouse |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Toulouse |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The delta ? 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). | 18 months | |
Secondary | Delta ? (post- versus pre-training) on the Intrinsic Motivation Inventory questionnaire compared between the 2 groups. | Delta ? (post- versus pre-training) on the Intrinsic Motivation Inventory questionnaire compared between the 2 groups. | 18 months | |
Secondary | Delta ? (post- and pre-training) in the acceptability questionnaire (BCI-ACCEPT) compared between the 2 groups. | Delta ? (post- and pre-training) in the acceptability questionnaire (BCI-ACCEPT) compared between the 2 groups. | 18 months | |
Secondary | 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. | 18 months | |
Secondary | 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. | 18 months | |
Secondary | Evolution of feeling VAS scores at each session, for both groups | Evolution of feeling VAS scores at each session, for both groups | 18 months | |
Secondary | 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. | 18 months | |
Secondary | 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 | 18 months | |
Secondary | Evaluation de la personnalité du patient en pré-entraînement (Questionnaire Big Five) | Assessment of the patient's personality in pre-training (Big Five Questionnaire) | 18 months | |
Secondary | 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) | 18 months | |
Secondary | Pre-training profiles of attentional abilities (Attention test) | Pre-training profiles of attentional abilities (Attention test) | 18 months | |
Secondary | Pre-training agency profiles (Agency Questionnaire) | Pre-training agency profiles (Agency Questionnaire) | 18 months | |
Secondary | 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. | 18 months | |
Secondary | 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. | 18 months | |
Secondary | 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 | 18 months |
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