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NCT Number: NCT04449068

Observational Database on Deep Brain Stimulation in Tourette Syndrome

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.

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Key information

Conditions

Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tic Disorders

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIC Neurosciences, GH Pitié-Salpêtrière

Paris, 75013, France

Location status: Recruiting

Location contact

Andres Hartmann, MD

CONTACT

[email protected]

01 42 16 13 16 ext. +33

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neurological and neuropsychological Follow-up after deep brain stimulation

Other

Investigation of tic severity, psychiatric co-morbidities, quality of life, and neuropsychologcial measures until the 5-year after deep brain stimulation (DBS)

EEG recordings

Device

EEG recordings at 2 visits (V1 and V2)

Primary outcomes

  1. Measure the severity of tics

    Time frame: 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 .

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas HARTMANN, MD

CONTACT

[email protected]

1 42 16 13 16 ext. +33

Yulia Worbe, MD,PHD

CONTACT

[email protected]

142161316 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: POSTSTIC

Important dates

Study start
2021
Primary completion
2036
Study completion
2036
First posted
Jun 26, 2020
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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