Brief Title
Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome
Official Title
Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome - A Pilot Study
Brief 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.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Yale Global Tic Severity Scale (YGTSS)
Secondary Outcome
Modified Rush Video Rating Scale and tic counts
Condition
Tourette's Syndrome
Intervention
Deep brain stimulator ventral electrode up to 2 mA
Study Arms / Comparison Groups
Deep brain stimulator ventral electrode up to 2 mA
Description: The ventral contact within the anterior globus pallidus interna near the ansa lenticularis is activated. Stimulator settings are 90 microseconds pulse width and stimulation frequency of 130 Hertz. Amplitude of stimulation is raised from zero until side effects occur or 2 mA amplitude is reached; whichever comes first.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
0
Start Date
March 2013
Completion Date
May 14, 2021
Primary Completion Date
May 14, 2021
Eligibility Criteria
Inclusion Criteria: - Age 14 to 60 years - Patient Group with Tourette's syndrome - severe and resistant to medical treatment including antipsychotic medication Exclusion Criteria: - Surgical contraindications to deep brain stimulation surgery - Major Depressive Episode within the previous 6 months - Schizophrenia or other psychotic disorder - Personality disorder impairing ability to reliably comply with study protocol - Significant cognitive impairment
Gender
All
Ages
14 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Christopher Lind, FRACS, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT02112253
Organization ID
2012-120
Responsible Party
Principal Investigator
Study Sponsor
The University of Western Australia
Collaborators
Sir Charles Gairdner Hospital
Study Sponsor
Christopher Lind, FRACS, Principal Investigator, The University of Western Australia
Verification Date
May 2021