Recording brain activity in patients with essential tremor
Study of the Activity of the Ventral Intermediate Nucleus of the Thalamus Under Ecological Conditions in Essential Tremor.
This study is testing a new device that records brain activity in people with essential tremor to see if it can help improve their treatment by only stimulating the brain when needed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT05671848 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with essential tremor (ET) who are receiving deep brain stimulation (DBS) treatment using the new PERCEPT™ device. The aim is to record thalamic Local Field Potentials (LFP) during rest and movement to understand the variations in brain activity associated with tremors. By monitoring these brain signals in a non-invasive manner at home, the study seeks to develop a closed-loop therapy that stimulates the thalamus only when necessary, potentially improving treatment outcomes. Participants will be monitored weekly for a period of three months post-surgery to gather data on their tremor activity.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with advanced, drug-resistant essential tremor who are receiving DBS treatment.
Not a fit: Patients with major depressive syndrome, significant brain atrophy, or those unable to provide consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and personalized treatment for patients with essential tremor.
How similar studies have performed: Other studies have shown promise in using closed-loop systems for DBS, but this specific approach with the PERCEPT™ device is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Advanced disabling and drug-resistant tremor * Receiving deep brain stimulation treatment with implantation of the PERCEPT™ device according to standard care * Chronic progressive cardiac, renal, hematological or pulmonary diseases under treatment. * Patient aged between 18 to 75 years * Normal brain MRI * MATTIS score ≥ 130/144 or MOCA ≥ 24/30 * Subject affiliated with or benefiting from a social security plan * Free, informed and written consent signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research) Exclusion Criteria: * Major depressive syndrome (Beck scale \> 20) * MRI showing significant brain atrophy or significant hypersignals * Pregnant or breastfeeding women * Being unable to give personal consent * Be subject to a measure of legal protection (curatorship, guardianship) or placed under judicial protection.
Where this trial is running
Bordeaux
- CHU de Bordeaux — Bordeaux, France (Recruiting)
Study contacts
- Principal investigator: Edouard COURTIN, Dr — University Hospital, Bordeaux
- Study coordinator: Edouard COURTIN, Dr
- Email: edouard.courtin@chu-bordeaux.fr
- Phone: 05 57 82 12 42
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.