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Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome

Primary Purpose

Tourette's Syndrome

Status

Withdrawn

Phase

Phase 1

Locations

Australia

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Tourette's Syndrome focused on measuring Tourette's syndrome, Deep brain stimulation, Stereotactic surgery, Globus pallidus interna, Tics

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Sir Charles Gairdner Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

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

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Yale Global Tic Severity Scale (YGTSS)

Performed before surgery.

Yale Global Tic Severity Scale (YGTSS)

At the end of the first of four three-month randomized blinded stimulation periods.

Yale Global Tic Severity Scale (YGTSS)

At the end of the second of four three-month randomized blinded stimulation periods.

Yale Global Tic Severity Scale (YGTSS)

At the end of the third of four three-month randomized blinded stimulation periods.

Yale Global Tic Severity Scale (YGTSS)

At the end of the last of four three-month randomized blinded stimulation periods.

Yale Global Tic Severity Scale (YGTSS)

At the end of the 6 month non-randomized empirical stimulation period.

Secondary Outcome Measures

Modified Rush Video Rating Scale and tic counts

Performed before surgery.

Modified Rush Video Rating Scale and tic counts

At the end of the first of four three-month randomized blinded stimulation periods.

Modified Rush Video Rating Scale and tic counts

At the end of the second of four three-month randomized blinded stimulation periods.

Modified Rush Video Rating Scale and tic counts

At the end of the third of four three-month randomized blinded stimulation periods.

Modified Rush Video Rating Scale and tic counts

At the end of the last of four three-month randomized blinded stimulation periods.

Modified Rush Video Rating Scale and tic counts

At the end of the 6 month non-randomized empirical stimulation period.

Tourette's syndrome symptom list

Performed before surgery.

Tourette's syndrome symptom list

At the end of the first of four three-month randomized blinded stimulation periods.

Tourette's syndrome symptom list

At the end of the second of four three-month randomized blinded stimulation periods.

Tourette's syndrome symptom list

At the end of the third of four three-month randomized blinded stimulation periods.

Tourette's syndrome symptom list

At the end of the third of four three-month randomized blinded stimulation periods.

Tourette's syndrome symptom list

At the end of the 6 month non-randomized empirical stimulation period.

Short Form 36

Quality of life outcome measure. Performed before surgery.

Short Form 36

Quality of life outcome measure. At the end of the first of four three-month randomized blinded stimulation periods.

Short Form 36

Quality of life outcome measure. At the end of the second of four three-month randomized blinded stimulation periods.

Short Form 36

Quality of life outcome measure. At the end of the third of four three-month randomized blinded stimulation periods.

Short Form 36

Quality of life outcome measure. At the end of the last of four three-month randomized blinded stimulation periods.

Short Form 36

At the end of the 6 month non-randomized empirical stimulation period.

Montreal Cognitive Assessment (MoCA)

Performed before surgery.

Montreal Cognitive Assessment (MoCA)

At the end of the first of four three-month randomized blinded stimulation periods.

Montreal Cognitive Assessment (MoCA)

At the end of the second of four three-month randomized blinded stimulation periods.

Montreal Cognitive Assessment (MoCA)

At the end of the third of four three-month randomized blinded stimulation periods.

Montreal Cognitive Assessment (MoCA)

At the end of the last of four three-month randomized blinded stimulation periods.

Montreal Cognitive Assessment (MoCA)

At the end of the 6 month non-randomized empirical stimulation period.

Psychiatric interview including: Mini International Neuropsychiatric Interview (MINI; version 5.0.0), Montgomery Asberg Depression Rating Scale (MADRS), and Young Mania Rating Scale (YMRS)