Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome
NCT ID: NCT02112253
Last Updated: 2021-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2013-03-31
2021-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Deep brain stimulator ventral electrode up to 2 mA
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.
Deep brain stimulator ventral electrode up to 2 mA
Deep brain stimulator ventral electrode up to 3 mA
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 3 mA amplitude is reached; whichever comes first.
Deep brain stimulator ventral electrode up to 3 mA
Deep brain stimulator dorsal electrode up to 2 mA
The dorsal contact within the superior half of the anterior globus pallidus interna 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.
Deep brain stimulator dorsal electrode up to 2 mA
Deep brain stimulator dorsal electrode up to 3 mA
The dorsal contact within the superior half of the anterior globus pallidus interna 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 3 mA amplitude is reached; whichever comes first.
Deep brain stimulator dorsal electrode up to 3 mA
Deep brain stimulator empirical programming
Any of the four electrode contacts on each of the two deep brain stimulation leads can be activated in any combination with any amplitude, frequency or pulse width settings to achieve optimized clinical control of motor tics whilst minimizing side effects. Both programmer and patient may be unblinded. The assessors are blinded to stimulation settings.
Deep brain stimulator empirical programming
Interventions
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Deep brain stimulator ventral electrode up to 2 mA
Deep brain stimulator ventral electrode up to 3 mA
Deep brain stimulator dorsal electrode up to 2 mA
Deep brain stimulator dorsal electrode up to 3 mA
Deep brain stimulator empirical programming
Eligibility Criteria
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Inclusion Criteria
* Patient Group with Tourette's syndrome - severe and resistant to medical treatment including antipsychotic medication
Exclusion Criteria
* 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
14 Years
60 Years
ALL
No
Sponsors
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Sir Charles Gairdner Hospital
OTHER
Perron Institute for Neurological and Translational Science
OTHER
The University of Western Australia
OTHER
Responsible Party
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Professor Christopher Lind
Consultant Neurosurgeon
Principal Investigators
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Christopher Lind, FRACS
Role: PRINCIPAL_INVESTIGATOR
The University of Western Australia
Locations
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Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Countries
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Other Identifiers
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2012-120
Identifier Type: -
Identifier Source: org_study_id
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