Optimising Anterior Pallidal Deep Brain Stimulation for Tourette's Syndrome

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

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02112253

Enrollment

Registered

2014-04-11

Start date

2013-03-31

Completion date

2021-05-14

Last updated

2021-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tourette's Syndrome

Keywords

Tourette's syndrome, Deep brain stimulation, Stereotactic surgery, Globus pallidus interna, Tics

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.

Interventions

DEVICEDeep brain stimulator ventral electrode up to 2 mA

DEVICEDeep brain stimulator ventral electrode up to 3 mA

DEVICEDeep brain stimulator dorsal electrode up to 2 mA

DEVICEDeep brain stimulator dorsal electrode up to 3 mA

DEVICEDeep brain stimulator empirical programming

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

14 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Yale Global Tic Severity Scale (YGTSS)	At baseline	Performed before surgery.

Secondary

Measure	Time frame	Description
Modified Rush Video Rating Scale and tic counts	At baseline	Performed before surgery.
Tourette's syndrome symptom list	At baseline	Performed before surgery.
Short Form 36	At baseline	Quality of life outcome measure. Performed before surgery.
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 baseline	Performed before surgery.
Adverse effects list	3 months	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.
Montreal Cognitive Assessment (MoCA)	At baseline	Performed before surgery.

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026