Observational Database on Deep Brain Stimulation in Tourette Syndrome

Tourette Syndrome Clinical Trial

— POSTSTIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04449068
• Other study ID #: APHP190808
• Status: Recruiting
• Start date: January 12, 2021
• Est. completion date: June 12, 2031

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Andreas HARTMANN, MD
• Phone: 1 42 16 13 16
• Email: andreas.hartmann[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 12, 2031
• Est. primary completion date: June 12, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome

Intervention

Other:
• Neurological and neuropsychological Follow-up after deep brain stimulation
Investigation of tic severity, psychiatric co-morbidities, quality of life, and neuropsychologcial measures until the 5-year after deep brain stimulation (DBS)

Locations

Country	Name	City	State
France	CIC Neurosciences, GH Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (2)

Welter ML, Houeto JL, Thobois S, Bataille B, Guenot M, Worbe Y, Hartmann A, Czernecki V, Bardinet E, Yelnik J, du Montcel ST, Agid Y, Vidailhet M, Cornu P, Tanguy A, Ansquer S, Jaafari N, Poulet E, Serra G, Burbaud P, Cuny E, Aouizerate B, Pollak P, Chabardes S, Polosan M, Borg M, Fontaine D, Giordana B, Raoul S, Rouaud T, Sauvaget A, Jalenques I, Karachi C, Mallet L; STIC study group. Anterior pallidal deep brain stimulation for Tourette's syndrome: a randomised, double-blind, controlled trial. Lancet Neurol. 2017 Aug;16(8):610-619. doi: 10.1016/S1474-4422(17)30160-6. Epub 2017 Jun 20. — View Citation

Welter ML, Houeto JL, Worbe Y, Diallo MH, Hartmann A, Tezenas du Montcel S, Ansquer S, Thobois S, Fontaine D, Rouaud T, Cuny E, Karachi C, Mallet L; STIC study group. Long-term effects of anterior pallidal deep brain stimulation for tourette's syndrome. Mov Disord. 2019 Apr;34(4):586-588. doi: 10.1002/mds.27645. Epub 2019 Feb 20. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the severity of tics	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 .	Month 60