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Clinical Trials/NCT02112253
NCT02112253
Withdrawn
Phase 1

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

The University of Western Australia1 site in 1 countryMarch 2013

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Tourette's Syndrome
Sponsor
The University of Western Australia
Locations
1
Primary Endpoint
Yale Global Tic Severity Scale (YGTSS)
Status
Withdrawn
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
May 14, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Professor Christopher Lind

Consultant Neurosurgeon

The University of Western Australia

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

Outcomes

Primary Outcomes

Yale Global Tic Severity Scale (YGTSS)

Time Frame: 18 months

At the end of the 6 month non-randomized empirical stimulation period.

Secondary Outcomes

  • Modified Rush Video Rating Scale and tic counts(18 months)
  • Tourette's syndrome symptom list(18 months)
  • 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)
  • Short Form 36(18 months)
  • Montreal Cognitive Assessment (MoCA)(18 months)
  • Adverse effects list(12 months)

Study Sites (1)

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