Randomised Crossover Trial of DBS of Differential PSA Regions in Parkinson's Disease and Tremor

NCT ID: NCT01945567

Last Updated: 2021-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2020-08-30

Brief Summary

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The posterior subthalamic area holds promise as a target region for deep brain stimulation in tremor and Parkinson's disease. Using the magnetic resonance-directed implantable guide tube surgical technique, subregions of the posterior subthalamic area can be individually targetted on a single electrode lead trajectory. The hypothesis is that the caudal zona incerta may provide improved control of movement disorder symptoms than the more commonly stimulated dorsal zona incerta.

Detailed Description

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Randomisation between two treatment locations each programmed up to 3 milliamps in amplitude for 3 months: (1) caudal zona incerta and (2) dorsal zona incerta. This 6-month-long randomised phase is followed by 6 months of unblinded individualised empirically optimised settings programmed by a neurologist. Each of the three treatment periods ends with a full clinical, functional and quality of life assessment.

Conditions

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Parkinson's Disease Tremor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Dorsal zona incerta

Up to 3 mA, 60 us, 130 Hz deep brain stimulation

Group Type EXPERIMENTAL

Up to 3 mA, 60 us, 130 Hz deep brain stimulation

Intervention Type DEVICE

Caudal zona incerta

Up to 3 mA, 60 us, 130 Hz deep brain stimulation

Group Type EXPERIMENTAL

Up to 3 mA, 60 us, 130 Hz deep brain stimulation

Intervention Type DEVICE

Empirical deep brain stimulation

Empirical unblinded deep brain stimulation programming using any posterior subthalamic area electrode contact(s) and stimulation parameters to optimise clinical outcome.

Group Type EXPERIMENTAL

Empirical unblinded deep brain stimulation programming

Intervention Type DEVICE

Interventions

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Up to 3 mA, 60 us, 130 Hz deep brain stimulation

Intervention Type DEVICE

Empirical unblinded deep brain stimulation programming

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Medication-refractory tremor and/or Parkinson's disease as defined by UK Brain Bank criteria with either inadequate control of motor fluctuations or dyskinesia despite optimised medical therapy

Exclusion Criteria

* Significant cognitive, psychiatric and medical co-morbidities
* Dementia with mini mental state examination score of less than 25/30
* Limited life expectancy due to a co-morbid condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Western Australia

OTHER

Sponsor Role lead

Responsible Party

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Professor Christopher Lind

Professor, School of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christopher Lind, MBChB, FRACS

Role: PRINCIPAL_INVESTIGATOR

The University of Western Australia

Locations

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Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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2012-039

Identifier Type: -

Identifier Source: org_study_id

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