Clinical trial NCT06212219: Neurofeedback-EEG Rehabilitation Protocol on Motor Recovery in the Subacute Phase Post-stroke (CUSTOM-NF-STROKE)
Official title: Impact of Personalization of a Neurofeedback-EEG Rehabilitation Protocol on Motor Recovery in the Subacute Phase Post-stroke (CUSTOM-NF-STROKE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebrovascular Accident
Keywords: Neurofeedback
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The delta Δ measured (post- versus pre-training) by the Fugl-Meyer test of the upper limb between the 2 groups
timeFrame: 18 months
Secondary outcomes:
measure: Delta Δ (post- versus pre-training) on the Intrinsic Motivation Inventory questionnaire compared between the 2 groups.
timeFrame: 18 months
measure: Delta Δ (post- and pre-training) in the acceptability questionnaire (BCI-ACCEPT) compared between the 2 groups.
timeFrame: 18 months
measure: The difference in the scores of the two groups on the System Usability Scale (SUS) questionnaire post-training.
timeFrame: 18 months
measure: Evolution of NASA-TLX questionnaire scores during the sessions, for both groups.
timeFrame: 18 months
measure: Evolution of feeling VAS scores at each session, for both groups
timeFrame: 18 months
measure: Evolution of scores and Positive and Negative Affects questionnaire, at each session, for both groups.
timeFrame: 18 months
measure: Difference in pre-training mental imagery ability scores with the Kinesthetic and Visual Imagery Questionnaire for the two groups
timeFrame: 18 months
measure: Evaluation de la personnalité du patient en pré-entraînement (Questionnaire Big Five)
timeFrame: 18 months
measure: The psychological profiles of patients from the two groups in pre-training: locus of control score (KUT)
timeFrame: 18 months
measure: Pre-training profiles of attentional abilities (Attention test)
timeFrame: 18 months
measure: Pre-training agency profiles (Agency Questionnaire)
timeFrame: 18 months
measure: Delta (post- and pre-training) on the Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-A), compared between the 2 groups.
timeFrame: 18 months
measure: Observation of State Anxiety Inventory (STAI-Y State) scores during sessions, for both groups.
timeFrame: 18 months
measure: Delta (post- and pre-workout) changes in speed, accuracy and range of motion using the Reaching Performance Scale
timeFrame: 18 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de TOULOUSE
Study officials:
affiliation: University Hospital, Toulouse
name: GASQ David, MD
role: PRINCIPAL_INVESTIGATOR
References: