Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome

Phase 1

Withdrawn

• Conditions: Tourette's Syndrome

• Registration Number: NCT02112253
• Lead Sponsor: The University of Western Australia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-03-22
• Study First Submitted QC: 2014-04-09
• Study First Posted: 2014-04-11
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Primary Completion: 2021-05-14
• Study Completion: 2021-05-14
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Yale Global Tic Severity Scale (YGTSS)	18 months	At the end of the 6 month non-randomized empirical stimulation period.

Secondary Outcome Measures

Name	Time	Method
Modified Rush Video Rating Scale and tic counts	18 months	At the end of the 6 month non-randomized empirical stimulation period.
Tourette's syndrome symptom list	18 months	At the end of the 6 month non-randomized empirical stimulation period.
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)	18 months	At the end of the 6 month non-randomized empirical stimulation period.
Short Form 36	18 months	At the end of the 6 month non-randomized empirical stimulation period.
Montreal Cognitive Assessment (MoCA)	18 months	At the end of the 6 month non-randomized empirical stimulation period.
Adverse effects list	12 months	Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the 6 month non-randomized empirical stimulation period.

Trial Locations

Locations (1)

Sir Charles Gairdner Hospital; 🇦🇺 Perth, Western Australia, Australia