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| Name | Class |
|---|---|
| Sir Charles Gairdner Hospital | OTHER |
| Perron Institute for Neurological and Translational Science | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain stimulator ventral electrode up to 2 mA | Device |
| ||
| Deep brain stimulator ventral electrode up to 3 mA |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Rush Video Rating Scale and tic counts | Performed before surgery. | At baseline |
| Modified Rush Video Rating Scale and tic counts | At the end of the first of four three-month randomized blinded stimulation periods. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Lind, FRACS | The University of Western Australia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sir Charles Gairdner Hospital | Perth | Western Australia | 6009 | Australia |
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| 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 |
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| Deep brain stimulator dorsal electrode up to 2 mA | Device |
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| Deep brain stimulator dorsal electrode up to 3 mA | Device |
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| Deep brain stimulator empirical programming | Device |
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| 3 months |
| Modified Rush Video Rating Scale and tic counts | At the end of the second of four three-month randomized blinded stimulation periods. | 6 months |
| Modified Rush Video Rating Scale and tic counts | At the end of the third of four three-month randomized blinded stimulation periods. | 9 months |
| Modified Rush Video Rating Scale and tic counts | At the end of the last of four three-month randomized blinded stimulation periods. | 12 months |
| Modified Rush Video Rating Scale and tic counts | At the end of the 6 month non-randomized empirical stimulation period. | 18 months |
| Tourette's syndrome symptom list | Performed before surgery. | At baseline |
| Tourette's syndrome symptom list | At the end of the first of four three-month randomized blinded stimulation periods. | 3 months |
| Tourette's syndrome symptom list | At the end of the second of four three-month randomized blinded stimulation periods. | 6 months |
| Tourette's syndrome symptom list | At the end of the third of four three-month randomized blinded stimulation periods. | 9 months |
| Tourette's syndrome symptom list | At the end of the third of four three-month randomized blinded stimulation periods. | 12 months |
| Tourette's syndrome symptom list | At the end of the 6 month non-randomized empirical stimulation period. | 18 months |
| Short Form 36 | Quality of life outcome measure. Performed before surgery. | At baseline |
| Short Form 36 | Quality of life outcome measure. At the end of the first of four three-month randomized blinded stimulation periods. | 3 months |
| Short Form 36 | Quality of life outcome measure. At the end of the second of four three-month randomized blinded stimulation periods. | 6 months |
| Short Form 36 | Quality of life outcome measure. At the end of the third of four three-month randomized blinded stimulation periods. | 9 months |
| Short Form 36 | Quality of life outcome measure. At the end of the last of four three-month randomized blinded stimulation periods. | 12 months |
| Short Form 36 | At the end of the 6 month non-randomized empirical stimulation period. | 18 months |
| Montreal Cognitive Assessment (MoCA) | Performed before surgery. | At baseline |
| Montreal Cognitive Assessment (MoCA) | At the end of the first of four three-month randomized blinded stimulation periods. | 3 months |
| Montreal Cognitive Assessment (MoCA) | At the end of the second of four three-month randomized blinded stimulation periods. | 6 months |
| Montreal Cognitive Assessment (MoCA) | At the end of the third of four three-month randomized blinded stimulation periods. | 9 months |
| Montreal Cognitive Assessment (MoCA) | At the end of the last of four three-month randomized blinded stimulation periods. | 12 months |
| Montreal Cognitive Assessment (MoCA) | 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) | 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) | 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) | 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) | 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) | 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) | At the end of the 6 month non-randomized empirical stimulation period. | 18 months |
| Adverse effects list | 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 | 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 | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D005879 | Tourette Syndrome |
| D020323 | Tics |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020820 | Dyskinesias |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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