NCT03958617

Thalamic Deep Brain Stimulation for Tourette Syndrome

Thalamic Deep Brain Stimulation for Tourette's Syndrome: a Pragmatic Trial With Brief Randomized, Double-blinded Sham Controlled Sequences

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DEVICE	Bilateral Deep brain stimulation of the thalamus, Medtronic Device

Timeline

• Start date: 2014-05-01
• Primary completion: 2019-02-28
• Completion: 2019-03-31
• First posted: 2019-05-22
• Last updated: 2019-05-23

Locations

1 site across 1 country: Germany