Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome
NCT02112253 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2021-05-18
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
- 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
Sponsors & Collaborators
-
Sir Charles Gairdner Hospital
collaborator OTHER -
Perron Institute for Neurological and Translational Science
collaborator OTHER -
The University of Western Australia
lead OTHER
Principal Investigators
-
Christopher Lind, FRACS · The University of Western Australia
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 14 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2021-05-14
- Completion
- 2021-05-14
Countries
- Australia
Study Locations
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