Optimising Anterior Pallidal Deep Brain Stimulation for Tourette’s Syndrome

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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