Observational Database on Deep Brain Stimulation in Tourette Syndrome

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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)
• Устройство EEG recordings
  EEG recordings at 2 visits (V1 and V2)

Первичные конечные точки

• Measure the severity of tics [Срок оценки: Month 60]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 1 центр

• CIC Neurosciences, GH Pitié-Salpêtrière — Paris

Публикации

• 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 pa PMID 28645853
• 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. PMID 30788865

Идентификаторы

NCT: NCT04449068 · APHP190808

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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