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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Sir Charles Gairdner Hospital
Perth, Western Australia, Australia
Yale Global Tic Severity Scale (YGTSS)
Performed before surgery.
Time frame: At baseline
Yale Global Tic Severity Scale (YGTSS)
At the end of the first of four three-month randomized blinded stimulation periods.
Time frame: 3 months
Yale Global Tic Severity Scale (YGTSS)
At the end of the second of four three-month randomized blinded stimulation periods.
Time frame: 6 months
Yale Global Tic Severity Scale (YGTSS)
At the end of the third of four three-month randomized blinded stimulation periods.
Time frame: 9 months
Yale Global Tic Severity Scale (YGTSS)
At the end of the last of four three-month randomized blinded stimulation periods.
Time frame: 12 months
Yale Global Tic Severity Scale (YGTSS)
At the end of the 6 month non-randomized empirical stimulation period.
Time frame: 18 months
Modified Rush Video Rating Scale and tic counts
Performed before surgery.
Time frame: At baseline
Modified Rush Video Rating Scale and tic counts
At the end of the first of four three-month randomized blinded stimulation periods.
Time frame: 3 months
Modified Rush Video Rating Scale and tic counts
At the end of the second of four three-month randomized blinded stimulation periods.
Time frame: 6 months
Modified Rush Video Rating Scale and tic counts
At the end of the third of four three-month randomized blinded stimulation periods.
Time frame: 9 months
Modified Rush Video Rating Scale and tic counts
At the end of the last of four three-month randomized blinded stimulation periods.
Time frame: 12 months
Modified Rush Video Rating Scale and tic counts
At the end of the 6 month non-randomized empirical stimulation period.
Time frame: 18 months
Tourette's syndrome symptom list
Performed before surgery.
Time frame: At baseline
Tourette's syndrome symptom list
At the end of the first of four three-month randomized blinded stimulation periods.
Time frame: 3 months
Tourette's syndrome symptom list
At the end of the second of four three-month randomized blinded stimulation periods.
Time frame: 6 months
Tourette's syndrome symptom list
At the end of the third of four three-month randomized blinded stimulation periods.
Time frame: 9 months
Tourette's syndrome symptom list
At the end of the third of four three-month randomized blinded stimulation periods.
Time frame: 12 months
Tourette's syndrome symptom list
At the end of the 6 month non-randomized empirical stimulation period.
Time frame: 18 months
Short Form 36
Quality of life outcome measure. Performed before surgery.
Time frame: At baseline
Short Form 36
Quality of life outcome measure. At the end of the first of four three-month randomized blinded stimulation periods.
Time frame: 3 months
Short Form 36
Quality of life outcome measure. At the end of the second of four three-month randomized blinded stimulation periods.
Time frame: 6 months
Short Form 36
Quality of life outcome measure. At the end of the third of four three-month randomized blinded stimulation periods.
Time frame: 9 months
Short Form 36
Quality of life outcome measure. At the end of the last of four three-month randomized blinded stimulation periods.
Time frame: 12 months
Short Form 36
At the end of the 6 month non-randomized empirical stimulation period.
Time frame: 18 months
Montreal Cognitive Assessment (MoCA)
Performed before surgery.
Time frame: At baseline
Montreal Cognitive Assessment (MoCA)
At the end of the first of four three-month randomized blinded stimulation periods.
Time frame: 3 months
Montreal Cognitive Assessment (MoCA)
At the end of the second of four three-month randomized blinded stimulation periods.
Time frame: 6 months
Montreal Cognitive Assessment (MoCA)
At the end of the third of four three-month randomized blinded stimulation periods.
Time frame: 9 months
Montreal Cognitive Assessment (MoCA)
At the end of the last of four three-month randomized blinded stimulation periods.
Time frame: 12 months
Montreal Cognitive Assessment (MoCA)
At the end of the 6 month non-randomized empirical stimulation period.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
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