NCT06813300 Determination of Biomarkers of the Effectiveness of Deep Brain Stimulation by Direct Electrophysiological Recordings of Brain Activity in a Cognitive Context - LFP-DBS 2024
| NCT ID | NCT06813300 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier St Anne |
| Condition | Pathology Requiring Deep Brain Stimulation Therapy |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2024-09-18 |
| Primary Completion | 2036-04-25 |
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 250 participants in total. It began in 2024-09-18 with a primary completion date of 2036-04-25.
⚠ 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
Deep brain stimulation (DBS) is a therapeutic approach aimed at applying high-frequency, low-intensity electrical stimulation using electrodes implanted in subcortical structures and connected subcutaneously to a stimulator implanted in the abdomen. In recent years, new indications have been studied for severe and drug-resistant forms of several neurological and neuropsychiatric pathologies. Its non-lesional, reversible and customizable nature make it a therapy of choice. However, several factors are currently slowing down the evolution and optimization of SCP. The identification of objective, quantifiable and predictive criteria for the therapeutic effects of stimulation would allow an acceleration of the individualized identification of the therapeutic parameters of SCP. The surgical procedure for implanting the stimulation equipment is carried out in several stages, which offer unique opportunities to acquire individual imaging or electrophysiology data that are potentially predictive of the therapeutic effect of DBS. In order to continue the optimization of DBS procedures, and therefore to maximize its therapeutic effects, it seems crucial to us to take advantage of all the neurophysiological data likely to be collected during this procedure. Furthermore, given the multiplication of indications for SCP, it seems necessary to highlight specific markers. Thus, the use of neurocognitive and/or motor tests specific to each pathology and coupled with electrophysiological recordings and anatomical and functional examinations would make it possible to highlight specific functional biomarkers predictive of therapeutic effects.
Eligibility Criteria
Inclusion Criteria: * Adult patient * Patient suffering from a pathology requiring treatment with deep brain stimulation: neurological disease (e.g.: Parkinson Disease, Essential Tremors, dystonia, epilepsy, etc.) or psychiatric disease (e.g.: Obsessive Compulsive Disorder, depression, eating disorders, etc.). * Patient capable of understanding the study procedures and completing the self-questionnaires in French * Patient informed and having signed the informed consent form Exclusion Criteria: * Contraindications to DBS, neurosurgery or anesthesia * Patients with significant hemorrhagic or infectious risks * Patient unable to perform the neurocognitive or sensorimotor tests * Patient who is not a beneficiary of a social security system.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06813300 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pathology Requiring Deep Brain Stimulation Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06813300 currently recruiting?
Yes, NCT06813300 is actively recruiting participants. Contact the research team at philippe.domenech@ghu-paris.fr for enrollment information.
Where is the NCT06813300 trial being conducted?
This trial is being conducted at Grenoble, France, Paris, France.
Who is sponsoring the NCT06813300 clinical trial?
NCT06813300 is sponsored by Centre Hospitalier St Anne. The trial plans to enroll 250 participants.