Clinical trial NCT02112253: Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome
Official title: Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome - A Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Tourette's Syndrome
Keywords: Tourette's syndrome
Deep brain stimulation
Stereotactic surgery
Globus pallidus interna
Tics
Lead sponsor: The University of Western Australia
Sponsor class: OTHER
Collaborators: name: Sir Charles Gairdner Hospital
name: Perron Institute for Neurological and Translational Science
First posted: 2014-04-11
Enrollment: 0
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: At baseline
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: 3 months
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: 6 months
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: 9 months
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: 12 months
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: 18 months
Secondary outcomes:
measure: Modified Rush Video Rating Scale and tic counts
timeFrame: At baseline
measure: Modified Rush Video Rating Scale and tic counts
timeFrame: 3 months
measure: Modified Rush Video Rating Scale and tic counts
timeFrame: 6 months
measure: Modified Rush Video Rating Scale and tic counts
timeFrame: 9 months
measure: Modified Rush Video Rating Scale and tic counts
timeFrame: 12 months
measure: Modified Rush Video Rating Scale and tic counts
timeFrame: 18 months
measure: Tourette's syndrome symptom list
timeFrame: At baseline
measure: Tourette's syndrome symptom list
timeFrame: 3 months
measure: Tourette's syndrome symptom list
timeFrame: 6 months
measure: Tourette's syndrome symptom list
timeFrame: 9 months
measure: Tourette's syndrome symptom list
timeFrame: 12 months
measure: Tourette's syndrome symptom list
timeFrame: 18 months
measure: Short Form 36
timeFrame: At baseline
measure: Short Form 36
timeFrame: 3 months
measure: Short Form 36
timeFrame: 6 months
measure: Short Form 36
timeFrame: 9 months
measure: Short Form 36
timeFrame: 12 months
measure: Short Form 36
timeFrame: 18 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: At baseline
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 3 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 6 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 9 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 12 months
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: 18 months
measure: Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
timeFrame: At baseline
measure: Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
timeFrame: 3 months
measure: Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
timeFrame: 6 months
measure: Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
timeFrame: 9 months
measure: Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
timeFrame: 12 months
measure: Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)
timeFrame: 18 months
measure: Adverse effects list
timeFrame: 3 months
measure: Adverse effects list
timeFrame: 6 months
measure: Adverse effects list
timeFrame: 9 months
measure: Adverse effects list
timeFrame: 12 months
measure: Adverse effects list
timeFrame: 12 months
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
Study officials:
affiliation: The University of Western Australia
name: Christopher Lind, FRACS
role: PRINCIPAL_INVESTIGATOR
References: