NCT02112253

Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome

Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome - A Pilot Study

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Western Australia · Academic / Other
• Sex: All
• Age: 14 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The motor tics associated with Tourette's syndrome may be reduced with deep brain stimulation of the anterior globus pallidus. The best area within this brain region and the best stimulation device settings are currently unknown. This is a study in which deep versus superficial electrode contact positions and two different amplitudes of stimulation are compared under scientific conditions. The hypothesis is that one contact position/stimulation amplitude combination will provide a better outcome than the others. Each study participant receives each of four different anatomical position/stimulation amplitude setting combinations over a 12 month period in randomized order followed by a 6-month period of trial-and-error device programming to optimize control of motor tics. Motor tics, potential side effects, daily functioning and quality of life are assessed at the end of each trial stimulation period. At the end of the study, the study participant continues to have long-term deep brain stimulation treatment with whatever settings provide the most relief.

Conditions

• Tourette's Syndrome

Interventions

Type	Name	Description
DEVICE	Deep brain stimulator ventral electrode up to 2 mA
DEVICE	Deep brain stimulator ventral electrode up to 3 mA
DEVICE	Deep brain stimulator dorsal electrode up to 2 mA
DEVICE	Deep brain stimulator dorsal electrode up to 3 mA
DEVICE	Deep brain stimulator empirical programming

Timeline

• Start date: 2013-03-01
• Primary completion: 2021-05-14
• Completion: 2021-05-14
• First posted: 2014-04-11
• Last updated: 2021-05-18

Locations

1 site across 1 country: Australia