Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome

NCT ID: NCT02112253

Last Updated: 2021-05-18

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2021-05-14

Brief Summary

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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

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Conditions

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Tourette's Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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.

Group Type EXPERIMENTAL

Deep brain stimulator ventral electrode up to 2 mA

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Deep brain stimulator ventral electrode up to 3 mA

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Deep brain stimulator dorsal electrode up to 2 mA

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Deep brain stimulator dorsal electrode up to 3 mA

Intervention Type DEVICE

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.

Group Type ACTIVE_COMPARATOR

Deep brain stimulator empirical programming

Intervention Type DEVICE

Interventions

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Deep brain stimulator ventral electrode up to 2 mA

Intervention Type DEVICE

Deep brain stimulator ventral electrode up to 3 mA

Intervention Type DEVICE

Deep brain stimulator dorsal electrode up to 2 mA

Intervention Type DEVICE

Deep brain stimulator dorsal electrode up to 3 mA

Intervention Type DEVICE

Deep brain stimulator empirical programming

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sir Charles Gairdner Hospital

OTHER

Sponsor Role collaborator

Perron Institute for Neurological and Translational Science

OTHER

Sponsor Role collaborator

The University of Western Australia

OTHER

Sponsor Role lead

Responsible Party

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Professor Christopher Lind

Consultant Neurosurgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Australia

Other Identifiers

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2012-120

Identifier Type: -

Identifier Source: org_study_id

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