Observational Database on Deep Brain Stimulation in Tourette Syndrome
ConditionTourette Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age15+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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
This trial does not accept healthy volunteersQualifiers
Tourette syndrome severe and drug-resistant eligible for bilateral deep brain stimulation
Person who voluntarily and knowledgeably agreed to participate in the study
Disqualifiers
Non affiliation to a French social security system (recipient or assign) excluding AME
Trial population
Patient with Tourette syndrome eligible for bilateral deep brain stimulation of the anterior internal pallid globus
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Neurological and neuropsychological Follow-up after deep brain stimulation
Other interventionInvestigation of tic severity, psychiatric co-morbidities, quality of life, and neuropsychologcial measures until the 5-year after deep brain stimulation (DBS)
EEG recordings
DeviceEEG recordings at 2 visits (V1 and V2)
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Evaluation of patients with Tourette's Gilles Syndrome2 interventions
Trial outcomes
Primary outcomes
1
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 .
Time frame
Month 60Sponsors and contacts
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Source ClinicalTrials.gov