Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome

The University of Western Australia

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Tourette's Syndrome

Treatments: Device: Deep brain stimulator ventral electrode up to 3 mA; Device: Deep brain stimulator dorsal electrode up to 3 mA; Device: Deep brain stimulator ventral electrode up to 2 mA; Device: Deep brain stimulator dorsal electrode up to 2 mA; Device: Deep brain stimulator empirical programming

Study type: Interventional

Funder types: Other

Identifiers

NCT02112253

2012-120

Details and patient eligibility

About

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.

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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0 participants in 5 patient groups

Deep brain stimulator ventral electrode up to 2 mA

Experimental group

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.

Treatment:

Device: Deep brain stimulator ventral electrode up to 2 mA

Deep brain stimulator ventral electrode up to 3 mA

Experimental group

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 3 mA amplitude is reached; whichever comes first.

Treatment:

Device: Deep brain stimulator ventral electrode up to 3 mA

Deep brain stimulator dorsal electrode up to 2 mA

Experimental group

Description:

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.

Treatment:

Device: Deep brain stimulator dorsal electrode up to 2 mA

Deep brain stimulator dorsal electrode up to 3 mA

Experimental group

Description:

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.

Treatment:

Device: Deep brain stimulator dorsal electrode up to 3 mA

Deep brain stimulator empirical programming

Active Comparator group

Description:

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.

Treatment:

Device: Deep brain stimulator empirical programming