Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome

Tourette's Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02112253
• Other study ID #: 2012-120
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: March 2013
• Est. completion date: May 14, 2021

Study information

• Verified date: May 2021
• Source: The University of Western Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 14, 2021
• Est. primary completion date: May 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome
• Tourette's Syndrome

Intervention

Device:
• Deep brain stimulator ventral electrode up to 2 mA

• Deep brain stimulator ventral electrode up to 3 mA

• Deep brain stimulator dorsal electrode up to 2 mA

• Deep brain stimulator dorsal electrode up to 3 mA

• Deep brain stimulator empirical programming

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia

Sponsors (3)

Lead Sponsor	Collaborator
The University of Western Australia	Perron Institute for Neurological and Translational Science, Sir Charles Gairdner Hospital

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Yale Global Tic Severity Scale (YGTSS)	Performed before surgery.	At baseline
Primary	Yale Global Tic Severity Scale (YGTSS)	At the end of the first of four three-month randomized blinded stimulation periods.	3 months
Primary	Yale Global Tic Severity Scale (YGTSS)	At the end of the second of four three-month randomized blinded stimulation periods.	6 months
Primary	Yale Global Tic Severity Scale (YGTSS)	At the end of the third of four three-month randomized blinded stimulation periods.	9 months
Primary	Yale Global Tic Severity Scale (YGTSS)	At the end of the last of four three-month randomized blinded stimulation periods.	12 months
Primary	Yale Global Tic Severity Scale (YGTSS)	At the end of the 6 month non-randomized empirical stimulation period.	18 months
Secondary	Modified Rush Video Rating Scale and tic counts	Performed before surgery.	At baseline
Secondary	Modified Rush Video Rating Scale and tic counts	At the end of the first of four three-month randomized blinded stimulation periods.	3 months
Secondary	Modified Rush Video Rating Scale and tic counts	At the end of the second of four three-month randomized blinded stimulation periods.	6 months
Secondary	Modified Rush Video Rating Scale and tic counts	At the end of the third of four three-month randomized blinded stimulation periods.	9 months
Secondary	Modified Rush Video Rating Scale and tic counts	At the end of the last of four three-month randomized blinded stimulation periods.	12 months
Secondary	Modified Rush Video Rating Scale and tic counts	At the end of the 6 month non-randomized empirical stimulation period.	18 months
Secondary	Tourette's syndrome symptom list	Performed before surgery.	At baseline
Secondary	Tourette's syndrome symptom list	At the end of the first of four three-month randomized blinded stimulation periods.	3 months
Secondary	Tourette's syndrome symptom list	At the end of the second of four three-month randomized blinded stimulation periods.	6 months
Secondary	Tourette's syndrome symptom list	At the end of the third of four three-month randomized blinded stimulation periods.	9 months
Secondary	Tourette's syndrome symptom list	At the end of the third of four three-month randomized blinded stimulation periods.	12 months
Secondary	Tourette's syndrome symptom list	At the end of the 6 month non-randomized empirical stimulation period.	18 months
Secondary	Short Form 36	Quality of life outcome measure. Performed before surgery.	At baseline
Secondary	Short Form 36	Quality of life outcome measure. At the end of the first of four three-month randomized blinded stimulation periods.	3 months
Secondary	Short Form 36	Quality of life outcome measure. At the end of the second of four three-month randomized blinded stimulation periods.	6 months
Secondary	Short Form 36	Quality of life outcome measure. At the end of the third of four three-month randomized blinded stimulation periods.	9 months
Secondary	Short Form 36	Quality of life outcome measure. At the end of the last of four three-month randomized blinded stimulation periods.	12 months
Secondary	Short Form 36	At the end of the 6 month non-randomized empirical stimulation period.	18 months
Secondary	Montreal Cognitive Assessment (MoCA)	Performed before surgery.	At baseline
Secondary	Montreal Cognitive Assessment (MoCA)	At the end of the first of four three-month randomized blinded stimulation periods.	3 months
Secondary	Montreal Cognitive Assessment (MoCA)	At the end of the second of four three-month randomized blinded stimulation periods.	6 months
Secondary	Montreal Cognitive Assessment (MoCA)	At the end of the third of four three-month randomized blinded stimulation periods.	9 months
Secondary	Montreal Cognitive Assessment (MoCA)	At the end of the last of four three-month randomized blinded stimulation periods.	12 months
Secondary	Montreal Cognitive Assessment (MoCA)	At the end of the 6 month non-randomized empirical stimulation period.	18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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