Identifying Biomarkers for Effective Deep Brain Stimulation
Determination of Biomarkers of the Effectiveness of Deep Brain Stimulation by Direct Electrophysiological Recordings of Brain Activity in a Cognitive Context - LFP-DBS 2024
This study is trying to find specific brain signals that can help improve deep brain stimulation therapy for patients with severe neurological and psychiatric conditions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier St Anne Academic / other |
| Locations | 2 sites (Grenoble and 1 other locations) |
| Trial ID | NCT06813300 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the effectiveness of deep brain stimulation (DBS) therapy by identifying objective biomarkers through direct electrophysiological recordings of brain activity in a cognitive context. It focuses on patients with severe neurological and psychiatric conditions who require DBS, utilizing data collected during the surgical implantation process to optimize individualized treatment parameters. The goal is to establish predictive criteria that can accelerate the customization of DBS therapy for better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults suffering from conditions like Parkinson's disease, essential tremors, dystonia, epilepsy, obsessive-compulsive disorder, depression, or eating disorders who are eligible for DBS.
Not a fit: Patients with contraindications to DBS, significant hemorrhagic or infectious risks, or those unable to perform required tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized deep brain stimulation treatments for patients with severe neurological and psychiatric disorders.
How similar studies have performed: Other studies have explored similar approaches in optimizing DBS therapy, indicating potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Grenoble and 1 other locations
- Grenoble-Alpes Hospital Center — Grenoble, France (Not_yet_recruiting)
- Groupe Hospitalo-Universitaire Paris Psychiatrie et Neurosciences, Paris — Paris, France (Recruiting)
Study contacts
- Study coordinator: Philippe Domenech, Professor, MD, PhD
- Email: philippe.domenech@ghu-paris.fr
- Phone: 0033(0)149812201
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.