Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome

NCT02112253 | Withdrawn Phase 1 DMC

• 1 other identifier: 2012-120
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette's Syndrome

Keywords

Tourette's syndrome; Deep brain stimulation; Stereotactic surgery; Globus pallidus interna; Tics

Outcome Measures

Primary Outcomes (6)

• Yale Global Tic Severity Scale (YGTSS)

  Performed before surgery.

  At baseline

• Yale Global Tic Severity Scale (YGTSS)

  At the end of the first of four three-month randomized blinded stimulation periods.

  3 months

• Yale Global Tic Severity Scale (YGTSS)

  At the end of the second of four three-month randomized blinded stimulation periods.

  6 months

• Yale Global Tic Severity Scale (YGTSS)

  At the end of the third of four three-month randomized blinded stimulation periods.

  9 months

• Yale Global Tic Severity Scale (YGTSS)

  At the end of the last of four three-month randomized blinded stimulation periods.

  12 months

• Yale Global Tic Severity Scale (YGTSS)

  At the end of the 6 month non-randomized empirical stimulation period.

  18 months

Secondary Outcomes (35)

• Modified Rush Video Rating Scale and tic counts

  At baseline

• Modified Rush Video Rating Scale and tic counts

  3 months

• Modified Rush Video Rating Scale and tic counts

  6 months

• Modified Rush Video Rating Scale and tic counts

  9 months

• Modified Rush Video Rating Scale and tic counts

  12 months

Study Arms (5)

Deep brain stimulator ventral electrode up to 2 mA

EXPERIMENTAL

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.

Device: Deep brain stimulator ventral electrode up to 2 mA

Deep brain stimulator ventral electrode up to 3 mA

EXPERIMENTAL

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.

Device: Deep brain stimulator ventral electrode up to 3 mA

Deep brain stimulator dorsal electrode up to 2 mA

EXPERIMENTAL

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.

Device: Deep brain stimulator dorsal electrode up to 2 mA

Deep brain stimulator dorsal electrode up to 3 mA

EXPERIMENTAL

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.

Device: Deep brain stimulator dorsal electrode up to 3 mA

Deep brain stimulator empirical programming

ACTIVE COMPARATOR

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.

Device: Deep brain stimulator empirical programming

Interventions

Deep brain stimulator ventral electrode up to 2 mA DEVICE

Deep brain stimulator ventral electrode up to 2 mA

Deep brain stimulator ventral electrode up to 3 mA DEVICE

Deep brain stimulator ventral electrode up to 3 mA

Deep brain stimulator dorsal electrode up to 2 mA DEVICE

Deep brain stimulator dorsal electrode up to 2 mA

Deep brain stimulator dorsal electrode up to 3 mA DEVICE

Deep brain stimulator dorsal electrode up to 3 mA

Deep brain stimulator empirical programming DEVICE

Deep brain stimulator empirical programming

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 14 to 60 years
• Patient Group with Tourette's syndrome - severe and resistant to medical treatment including antipsychotic medication

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Western Australia: lead
• Sir Charles Gairdner Hospital: collaborator
• Perron Institute for Neurological and Translational Science: collaborator

Study Sites (1)

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Tourette Syndrome; Tics

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher Lind, FRACS

  The University of Western Australia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Neurosurgeon

Study Record Dates

• First Submitted: March 22, 2014
• First Posted: April 11, 2014
• Study Start: March 1, 2013
• Primary Completion: May 14, 2021
• Study Completion: May 14, 2021
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

AU (1)