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Subthalamic Stimulation in Tourette's Syndrome

NCT02619084 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2016-02-23

No results posted yet for this study

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.

Conditions

  • Tourette's Syndrome
  • Tourette Syndrome
  • Gilles de la Tourette Syndrome
  • Tourette Disorder

Interventions

PROCEDURE

STN DBS

Bilateral STN DBS

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    lead OTHER

Principal Investigators

  • Luigi M Romito, MD, PhD · IRCCS Istituto Neurologico Carlo Besta, Milano, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02619084 on ClinicalTrials.gov