Observational database on deep brain stimulation for Tourette syndrome
Pre et Post-operative Evaluation of Patients With Tourette Syndrome Treated With High Frequency Bilateral Stimulation of the Anterior Part of the Internal Pallid Globus
This study looks at how deep brain stimulation helps people with Tourette syndrome by tracking their tic severity and overall well-being for five years after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04449068 on ClinicalTrials.gov |
What this trial studies
This study evaluates patients with Tourette syndrome who are undergoing bilateral deep brain stimulation (DBS) at the Pitié-Salpêtrière Hospital in Paris. Patients will be assessed pre-operatively and then annually for five years post-surgery to monitor tic severity, psychiatric co-morbidities, quality of life, and neuropsychological functioning. The goal is to gather comprehensive data that may inform future multicenter trials and identify prognostic factors for response to DBS in Tourette syndrome.
Who should consider this trial
Good fit: Ideal candidates are individuals with severe, drug-resistant Tourette syndrome who are eligible for bilateral deep brain stimulation.
Not a fit: Patients who do not have Tourette syndrome or those who are not eligible for deep brain stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the long-term effects of DBS on Tourette syndrome and improve treatment outcomes for patients.
How similar studies have performed: Previous studies, such as the STIC trial, have shown ongoing improvement in tic severity with DBS, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Tourette syndrome severe and drug-resistant eligible for bilateral deep brain stimulation * Person who voluntarily and knowledgeably agreed to participate in the study Exclusion Criteria: * Non affiliation to a French social security system (recipient or assign) excluding AME
Where this trial is running
Paris
- CIC Neurosciences, GH Pitié-Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Andreas HARTMANN, MD
- Email: andreas.hartmann@aphp.fr
- Phone: 1 42 16 13 16
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.