Observational Database on Deep Brain Stimulation in Tourette Syndrome

Recruiting

• Conditions: Tourette Syndrome
• Interventions: Other: Neurological and neuropsychological Follow-up after deep brain stimulation

• Registration Number: NCT04449068
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Within an ongoing deep brain stimulation (DBS) program for Tourette syndrome (TS) at the Department of Neurology, Pitié-Salpêtrière Hospital, Paris/France, the investigator team plans to evaluate patients pre-operatively and then at one year intervals post-operatively until the 5-year mark has been achieved. The investigator team will investigate tic severity, psychiatric co-morbidities, quality of life, and neuropsychological measures.

Detailed Description

Since the completion of the STIC trial in 2017, the french team continues to offer DBS of the globus pallidus internus (GPi) to selected, treatment-refractory patients with TS. On average, three to four patients undergo surgery every year. Even though a first follow-up of the STIC cohort up to four years post-op indicates ongoing improvement of tic severity, many questions remains regarding the efficacy of GPi DBS in TS. These questions include frequent comorbidities of TS, quality of life, evolution of medication and stimulation parameters, as well as neuropsychological functioning. Therefore, the investigator proposes to evaluate all patients undergoing GPi DBS for TS to be evaluated comprehensively pre-operatively and once yearly after surgery until reaching the 5-year mark. The investigator team hopes these data may help to plan for future international multicenter trials, and provide indications on prognostic factors concerning response to GPi DBS in TS.

Study Timeline

• Study First Submitted: 2020-06-23
• Study First Submitted QC: 2020-06-23
• Study First Posted: 2020-06-26
• Study Start: 2021-01-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-19
• Last Update Posted: 2024-01-23
• Primary Completion: 2031-06-12
• Study Completion: 2031-06-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Evaluation of patients with Tourette's Gilles Syndrome	Neurological and neuropsychological Follow-up after deep brain stimulation	Neurological and neuropsychological evaluations of patients with Tourette's Gilles syndrome treated with high frequency bilateral stimulation of the anterior part of the internal pallid globus

Primary Outcome Measures

Name	Time	Method
Measure the severity of tics	Month 60	Measure the severity of tics, determined by the YGTSS-R (Yale Global Tic Severity Scale score - revised) .; The overall score is between 0 (no TICS) and 100 (severity in TICS) therefore a score decrease is expected .

Trial Locations

Locations (1)

CIC Neurosciences, GH Pitié-Salpêtrière; 🇫🇷 Paris, France