Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome

NCT02112253 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2021-05-18

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02112253 on ClinicalTrials.gov