NCT06212219 Neurofeedback-EEG Rehabilitation Protocol on Motor Recovery in the Subacute Phase Post-stroke (CUSTOM-NF-STROKE)
| NCT ID | NCT06212219 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Cerebrovascular Accident |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-01-08 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2024-01-08 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
GASQ David, MD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT06212219 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Cerebrovascular Accident. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06212219 currently recruiting?
Yes, NCT06212219 is actively recruiting participants. Contact the research team at gasq.d@chu-toulouse.fr for enrollment information.
Where is the NCT06212219 trial being conducted?
This trial is being conducted at Toulouse, France.
Who is sponsoring the NCT06212219 clinical trial?
NCT06212219 is sponsored by University Hospital, Toulouse. The principal investigator is GASQ David, MD at University Hospital, Toulouse. The trial plans to enroll 44 participants.