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Thalamic Deep Brain Stimulation for Tourette Syndrome

NCT03958617 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2019-05-23

No results posted yet for this study

Summary

In this single-center trial, we aim to include 8 patients with severe and medically refractory Tourette's syndrome. All patients undergo deep brain stimulation surgery with two electrodes located in the centromedian-parafascicular complex. Tic severity and secondary outcome measurements are assessed six and twelve months after surgery. Additionally, a short randomized, double-blinded sham controlled crossover sequence of 24 to 48 hours in either active or sham stimulation is implemented after both 6 and 12 months assesments. Subjects and clinicians are blinded to treatment allocation.

Conditions

  • Tourette Syndrome

Interventions

DEVICE

Bilateral Deep brain stimulation of the thalamus, Medtronic Device

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • University of Cologne

    lead OTHER

Principal Investigators

  • Jens Kuhn, MD · University Hospital of Cologne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2014-05-01
Primary Completion
2019-02-28
Completion
2019-03-31

Countries

  • Germany

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 NCT03958617 on ClinicalTrials.gov