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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02112253




Registration number
NCT02112253
Ethics application status
Date submitted
22/03/2014
Date registered
11/04/2014
Date last updated
31/12/2014

Titles & IDs
Public title
Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome
Scientific title
Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome - A Pilot Study
Secondary ID [1] 0 0
2012-120
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tourette's Syndrome 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Other 0 0 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Deep brain stimulator ventral electrode up to 2 mA
Treatment: Devices - Deep brain stimulator ventral electrode up to 3 mA
Treatment: Devices - Deep brain stimulator dorsal electrode up to 2 mA
Treatment: Devices - Deep brain stimulator dorsal electrode up to 3 mA
Treatment: Devices - Deep brain stimulator empirical programming

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.

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.

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.

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.

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.


Treatment: Devices: Deep brain stimulator ventral electrode up to 2 mA


Treatment: Devices: Deep brain stimulator ventral electrode up to 3 mA


Treatment: Devices: Deep brain stimulator dorsal electrode up to 2 mA


Treatment: Devices: Deep brain stimulator dorsal electrode up to 3 mA


Treatment: Devices: Deep brain stimulator empirical programming


Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Yale Global Tic Severity Scale (YGTSS) - Performed before surgery.
Timepoint [1] 0 0
At baseline
Primary outcome [2] 0 0
Yale Global Tic Severity Scale (YGTSS) - At the end of the first of four three-month randomized blinded stimulation periods.
Timepoint [2] 0 0
3 months
Primary outcome [3] 0 0
Yale Global Tic Severity Scale (YGTSS) - At the end of the second of four three-month randomized blinded stimulation periods.
Timepoint [3] 0 0
6 months
Primary outcome [4] 0 0
Yale Global Tic Severity Scale (YGTSS) - At the end of the third of four three-month randomized blinded stimulation periods.
Timepoint [4] 0 0
9 months
Primary outcome [5] 0 0
Yale Global Tic Severity Scale (YGTSS) - At the end of the last of four three-month randomized blinded stimulation periods.
Timepoint [5] 0 0
12 months
Primary outcome [6] 0 0
Yale Global Tic Severity Scale (YGTSS) - At the end of the 6 month non-randomized empirical stimulation period.
Timepoint [6] 0 0
18 months
Secondary outcome [1] 0 0
Modified Rush Video Rating Scale and tic counts - Performed before surgery.
Timepoint [1] 0 0
At baseline
Secondary outcome [2] 0 0
Modified Rush Video Rating Scale and tic counts - At the end of the first of four three-month randomized blinded stimulation periods.
Timepoint [2] 0 0
3 months
Secondary outcome [3] 0 0
Modified Rush Video Rating Scale and tic counts - At the end of the second of four three-month randomized blinded stimulation periods.
Timepoint [3] 0 0
6 months
Secondary outcome [4] 0 0
Modified Rush Video Rating Scale and tic counts - At the end of the third of four three-month randomized blinded stimulation periods.
Timepoint [4] 0 0
9 months
Secondary outcome [5] 0 0
Modified Rush Video Rating Scale and tic counts - At the end of the last of four three-month randomized blinded stimulation periods.
Timepoint [5] 0 0
12 months
Secondary outcome [6] 0 0
Modified Rush Video Rating Scale and tic counts - At the end of the 6 month non-randomized empirical stimulation period.
Timepoint [6] 0 0
18 months
Secondary outcome [7] 0 0
Tourette's syndrome symptom list - Performed before surgery.
Timepoint [7] 0 0
At baseline
Secondary outcome [8] 0 0
Tourette's syndrome symptom list - At the end of the first of four three-month randomized blinded stimulation periods.
Timepoint [8] 0 0
3 months
Secondary outcome [9] 0 0
Tourette's syndrome symptom list - At the end of the second of four three-month randomized blinded stimulation periods.
Timepoint [9] 0 0
6 months
Secondary outcome [10] 0 0
Tourette's syndrome symptom list - At the end of the third of four three-month randomized blinded stimulation periods.
Timepoint [10] 0 0
9 months
Secondary outcome [11] 0 0
Tourette's syndrome symptom list - At the end of the third of four three-month randomized blinded stimulation periods.
Timepoint [11] 0 0
12 months
Secondary outcome [12] 0 0
Tourette's syndrome symptom list - At the end of the 6 month non-randomized empirical stimulation period.
Timepoint [12] 0 0
18 months
Secondary outcome [13] 0 0
Short Form 36 - Quality of life outcome measure. Performed before surgery.
Timepoint [13] 0 0
At baseline
Secondary outcome [14] 0 0
Short Form 36 - Quality of life outcome measure. At the end of the first of four three-month randomized blinded stimulation periods.
Timepoint [14] 0 0
3 months
Secondary outcome [15] 0 0
Short Form 36 - Quality of life outcome measure. At the end of the second of four three-month randomized blinded stimulation periods.
Timepoint [15] 0 0
6 months
Secondary outcome [16] 0 0
Short Form 36 - Quality of life outcome measure. At the end of the third of four three-month randomized blinded stimulation periods.
Timepoint [16] 0 0
9 months
Secondary outcome [17] 0 0
Short Form 36 - Quality of life outcome measure. At the end of the last of four three-month randomized blinded stimulation periods.
Timepoint [17] 0 0
12 months
Secondary outcome [18] 0 0
Short Form 36 - At the end of the 6 month non-randomized empirical stimulation period.
Timepoint [18] 0 0
18 months
Secondary outcome [19] 0 0
Montreal Cognitive Assessment (MoCA) - Performed before surgery.
Timepoint [19] 0 0
At baseline
Secondary outcome [20] 0 0
Montreal Cognitive Assessment (MoCA) - At the end of the first of four three-month randomized blinded stimulation periods.
Timepoint [20] 0 0
3 months
Secondary outcome [21] 0 0
Montreal Cognitive Assessment (MoCA) - At the end of the second of four three-month randomized blinded stimulation periods.
Timepoint [21] 0 0
6 months
Secondary outcome [22] 0 0
Montreal Cognitive Assessment (MoCA) - At the end of the third of four three-month randomized blinded stimulation periods.
Timepoint [22] 0 0
9 months
Secondary outcome [23] 0 0
Montreal Cognitive Assessment (MoCA) - At the end of the last of four three-month randomized blinded stimulation periods.
Timepoint [23] 0 0
12 months
Secondary outcome [24] 0 0
Montreal Cognitive Assessment (MoCA) - At the end of the 6 month non-randomized empirical stimulation period.
Timepoint [24] 0 0
18 months
Secondary outcome [25] 0 0
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.
Timepoint [25] 0 0
At baseline
Secondary outcome [26] 0 0
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.
Timepoint [26] 0 0
3 months
Secondary outcome [27] 0 0
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.
Timepoint [27] 0 0
6 months
Secondary outcome [28] 0 0
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.
Timepoint [28] 0 0
9 months
Secondary outcome [29] 0 0
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.
Timepoint [29] 0 0
12 months
Secondary outcome [30] 0 0
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.
Timepoint [30] 0 0
18 months
Secondary outcome [31] 0 0
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.
Timepoint [31] 0 0
3 months
Secondary outcome [32] 0 0
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.
Timepoint [32] 0 0
6 months
Secondary outcome [33] 0 0
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.
Timepoint [33] 0 0
9 months
Secondary outcome [34] 0 0
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.
Timepoint [34] 0 0
12 months
Secondary outcome [35] 0 0
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.
Timepoint [35] 0 0
12 months

Eligibility
Key inclusion criteria
- Age 14 to 60 years

- Patient Group with Tourette's syndrome - severe and resistant to medical treatment
including antipsychotic medication
Minimum age
14 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Western Australia
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Sir Charles Gairdner Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian Neuromuscular Research Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02112253
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher Lind, FRACS
Address 0 0
The University of Western Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Christopher Lind, FRACS
Address 0 0
Country 0 0
Phone 0 0
+61 8 9346 2865
Fax 0 0
Email 0 0
Christopher.Lind@health.wa.gov.au
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02112253