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

T

Toulouse University Hospital

Status

Enrolling

Conditions

Cerebrovascular Accident

Treatments

Behavioral: Neurofeedback procedure
Other: Self-questionnaire: OCEAN of the five major factors of per- sound (or Big Five model)
Other: System Usability Scale questionnaire
Other: Acceptability questionnaire (BCI-ACCEPT)
Other: Hospital Anxiety and Depression Scale
Other: Technology Locus of Control Assessment Questionnaire
Other: POSITIVE AFFECTIVITY AND NEGATIVE AFFECTIVITY SCALE
Other: Visual and Kinesthetic Imagery Questionnaire
Other: Feeling VAS scores
Other: Agency test
Other: Reaching Performance Scale
Other: State Anxiety Inventory scores
Other: NASA Task Load Index questionnaire
Other: Intrinsic Motivation Inventory questionnaire
Other: Fugl-Meyer test

Study type

Interventional

Funder types

Other

Identifiers

NCT06212219
RC31/22/0477

Details and patient eligibility

About

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.

Full 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.

Enrollment

44 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

Standard Neurofeedback Procedure
Active Comparator group
Description:
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.
Treatment:
Other: Fugl-Meyer test
Other: Intrinsic Motivation Inventory questionnaire
Other: NASA Task Load Index questionnaire
Other: State Anxiety Inventory scores
Other: Reaching Performance Scale
Other: Agency test
Other: Feeling VAS scores
Other: Visual and Kinesthetic Imagery Questionnaire
Other: POSITIVE AFFECTIVITY AND NEGATIVE AFFECTIVITY SCALE
Other: Technology Locus of Control Assessment Questionnaire
Other: Hospital Anxiety and Depression Scale
Other: Self-questionnaire: OCEAN of the five major factors of per- sound (or Big Five model)
Other: System Usability Scale questionnaire
Other: Acceptability questionnaire (BCI-ACCEPT)
Behavioral: Neurofeedback procedure
Personalized Neurofeedback Procedure
Experimental group
Description:
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.
Treatment:
Other: Fugl-Meyer test
Other: Intrinsic Motivation Inventory questionnaire
Other: NASA Task Load Index questionnaire
Other: State Anxiety Inventory scores
Other: Reaching Performance Scale
Other: Agency test
Other: Feeling VAS scores
Other: Visual and Kinesthetic Imagery Questionnaire
Other: POSITIVE AFFECTIVITY AND NEGATIVE AFFECTIVITY SCALE
Other: Technology Locus of Control Assessment Questionnaire
Other: Hospital Anxiety and Depression Scale
Other: Self-questionnaire: OCEAN of the five major factors of per- sound (or Big Five model)
Other: System Usability Scale questionnaire
Other: Acceptability questionnaire (BCI-ACCEPT)
Behavioral: Neurofeedback procedure

Trial contacts and locations

1

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Central trial contact

GASQ David, MD; TOMASIK Audrey

Data sourced from clinicaltrials.gov

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