Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome

May 13, 2021 updated by: Professor Christopher Lind, The University of Western Australia

Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome - A Pilot Study

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Device: Deep brain stimulator ventral electrode up to 2 mA
Experimental: 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.
Device: Deep brain stimulator ventral electrode up to 3 mA
Experimental: 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.
Device: Deep brain stimulator dorsal electrode up to 2 mA
Experimental: 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.
Device: Deep brain stimulator dorsal electrode up to 3 mA
Active Comparator: 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.
Device: Deep brain stimulator empirical programming

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Yale Global Tic Severity Scale (YGTSS)
Time Frame: At baseline
Performed before surgery.
At baseline
Yale Global Tic Severity Scale (YGTSS)
Time Frame: 3 months
At the end of the first of four three-month randomized blinded stimulation periods.
3 months
Yale Global Tic Severity Scale (YGTSS)
Time Frame: 6 months
At the end of the second of four three-month randomized blinded stimulation periods.
6 months
Yale Global Tic Severity Scale (YGTSS)
Time Frame: 9 months
At the end of the third of four three-month randomized blinded stimulation periods.
9 months
Yale Global Tic Severity Scale (YGTSS)
Time Frame: 12 months
At the end of the last of four three-month randomized blinded stimulation periods.
12 months
Yale Global Tic Severity Scale (YGTSS)
Time Frame: 18 months
At the end of the 6 month non-randomized empirical stimulation period.
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Modified Rush Video Rating Scale and tic counts
Time Frame: At baseline
Performed before surgery.
At baseline
Modified Rush Video Rating Scale and tic counts
Time Frame: 3 months
At the end of the first of four three-month randomized blinded stimulation periods.
3 months
Modified Rush Video Rating Scale and tic counts
Time Frame: 6 months
At the end of the second of four three-month randomized blinded stimulation periods.
6 months
Modified Rush Video Rating Scale and tic counts
Time Frame: 9 months
At the end of the third of four three-month randomized blinded stimulation periods.
9 months
Modified Rush Video Rating Scale and tic counts
Time Frame: 12 months
At the end of the last of four three-month randomized blinded stimulation periods.
12 months
Modified Rush Video Rating Scale and tic counts
Time Frame: 18 months
At the end of the 6 month non-randomized empirical stimulation period.
18 months
Tourette's syndrome symptom list
Time Frame: At baseline
Performed before surgery.
At baseline
Tourette's syndrome symptom list
Time Frame: 3 months
At the end of the first of four three-month randomized blinded stimulation periods.
3 months
Tourette's syndrome symptom list
Time Frame: 6 months
At the end of the second of four three-month randomized blinded stimulation periods.
6 months
Tourette's syndrome symptom list
Time Frame: 9 months
At the end of the third of four three-month randomized blinded stimulation periods.
9 months
Tourette's syndrome symptom list
Time Frame: 12 months
At the end of the third of four three-month randomized blinded stimulation periods.
12 months
Tourette's syndrome symptom list
Time Frame: 18 months
At the end of the 6 month non-randomized empirical stimulation period.
18 months
Short Form 36
Time Frame: At baseline
Quality of life outcome measure. Performed before surgery.
At baseline
Short Form 36
Time Frame: 3 months
Quality of life outcome measure. At the end of the first of four three-month randomized blinded stimulation periods.
3 months
Short Form 36
Time Frame: 6 months
Quality of life outcome measure. At the end of the second of four three-month randomized blinded stimulation periods.
6 months
Short Form 36
Time Frame: 9 months
Quality of life outcome measure. At the end of the third of four three-month randomized blinded stimulation periods.
9 months
Short Form 36
Time Frame: 12 months
Quality of life outcome measure. At the end of the last of four three-month randomized blinded stimulation periods.
12 months
Short Form 36
Time Frame: 18 months
At the end of the 6 month non-randomized empirical stimulation period.
18 months
Montreal Cognitive Assessment (MoCA)
Time Frame: At baseline
Performed before surgery.
At baseline
Montreal Cognitive Assessment (MoCA)
Time Frame: 3 months
At the end of the first of four three-month randomized blinded stimulation periods.
3 months
Montreal Cognitive Assessment (MoCA)
Time Frame: 6 months
At the end of the second of four three-month randomized blinded stimulation periods.
6 months
Montreal Cognitive Assessment (MoCA)
Time Frame: 9 months
At the end of the third of four three-month randomized blinded stimulation periods.
9 months
Montreal Cognitive Assessment (MoCA)
Time Frame: 12 months
At the end of the last of four three-month randomized blinded stimulation periods.
12 months
Montreal Cognitive Assessment (MoCA)
Time Frame: 18 months
At the end of the 6 month non-randomized empirical stimulation period.
18 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Time Frame: At baseline
Performed before surgery.
At baseline
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Time Frame: 3 months
At the end of the first of four three-month randomized blinded stimulation periods.
3 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Time Frame: 6 months
At the end of the second of four three-month randomized blinded stimulation periods.
6 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Time Frame: 9 months
At the end of the third of four three-month randomized blinded stimulation periods.
9 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Time Frame: 12 months
At the end of the last of four three-month randomized blinded stimulation periods.
12 months
Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
Time Frame: 18 months
At the end of the 6 month non-randomized empirical stimulation period.
18 months
Adverse effects list
Time Frame: 3 months
Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the first of four three-month randomized blinded stimulation periods.
3 months
Adverse effects list
Time Frame: 6 months
Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the second of four three-month randomized blinded stimulation periods.
6 months
Adverse effects list
Time Frame: 9 months
Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the third of four three-month randomized blinded stimulation periods.
9 months
Adverse effects list
Time Frame: 12 months
Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the last of four three-month randomized blinded stimulation periods.
12 months
Adverse effects list
Time Frame: 12 months
Registered and notified to principal investigator whenever detected. Also specifically sought at the end of the 6 month non-randomized empirical stimulation period.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Western Australia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sir Charles Gairdner Hospital
Perron Institute for Neurological and Translational Science

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Lind, FRACS, The University of Western Australia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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