Observational Database on Deep Brain Stimulation in Tourette Syndrome

Last updated: January 19, 2024
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Tic Disorders

Treatment

Neurological and neuropsychological Follow-up after deep brain stimulation

Clinical Study ID

NCT04449068
APHP190808
  • Ages > 15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Tourette syndrome severe and drug-resistant eligible for bilateral deep brainstimulation
  • Person who voluntarily and knowledgeably agreed to participate in the study

Exclusion

Exclusion Criteria:

  • Non affiliation to a French social security system (recipient or assign) excluding AME

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Neurological and neuropsychological Follow-up after deep brain stimulation
Phase:
Study Start date:
January 12, 2021
Estimated Completion Date:
June 12, 2031

Study 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.

Connect with a study center

  • CIC Neurosciences, GH Pitié-Salpêtrière

    Paris, 75013
    France

    Active - Recruiting

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