CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
STN DBSprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02619084
NCT02619084Phase 2Completed
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Subthalamic Nucleus Deep Brain Stimulation in Tourette's Syndrome

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta·interventional·Posted Dec 2, 2015·Updated Feb 23, 2016

In Brief

A Phase 2 clinical trial evaluating STN DBS for Tourette's Syndrome and 3 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The main objective of this project is to evaluate the efficacy of subthalamic nucleus deep brain stimulation (STN DBS) in treating motor and phonic tics in medically refractory Tourette's syndrome (TS). Secondary objectives are to individuate and standardize the best electrical parameters for STN stimulation in TS, to evaluate the efficacy and safety on non-motor TS features, such as behavioral abnormalities and psychiatric disorders, during chronic STN stimulation, to correlate the improvement of TS motor and non-motor symptoms to the modification in brain activity recorded by PET study and to explore the pathophysiology of TS, and to evaluate the safety of STN DBS in TS patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTourette's Syndrome, Tourette Syndrome, Gilles de la Tourette Syndrome, Tourette Disorder
CountriesItaly
CollaboratorsMinistry of Health, Italy

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2, 2015
Enrollment StartDec 1, 2011
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 10.6 years ago

Interventions

STN DBSprocedure

Bilateral STN DBS