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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU de TOULOUSE
RECRUITING
Toulouse
Contact Information
Primary
GASQ David, MD
gasq.d@chu-toulouse.fr
5 61 32 28 42
Backup
TOMASIK Audrey
tomasik.a@chu-toulouse.fr
5 61 77 85 97
Time Frame
Start Date: 2024-01-08
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 44
Treatments
Active_comparator: Standard 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.
Experimental: Personalized 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.
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Toulouse

This content was sourced from clinicaltrials.gov