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Observational Database on Deep Brain Stimulation in 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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04449068
Acronym
POSTSTIC
Enrollment
20
Registered
2020-06-26
Start date
2021-01-12
Completion date
2036-06-12
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourette Syndrome

Keywords

bilateral deep brain stimulation, Tourette syndrome,

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.

Interventions

OTHERNeurological 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)

DEVICEEEG recordings

EEG recordings at 2 visits (V1 and V2)

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure the severity of ticsMonth 60Measure 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 .

Countries

France

Contacts

CONTACTAndreas HARTMANN, MD
andreas.hartmann@aphp.fr1 42 16 13 16
CONTACTYulia Worbe, MD,PHD
yulia.worbe@aphp.fr142161316

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026