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

May 13, 2021 updated by: Professor Christopher Lind, The University of Western Australia

Randomised Crossover Trial of Deep Brain Stimulation of Differential Posterior Subthalamic Area Regions in Parkinson's Disease and Tremor

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Sir Charles Gairdner Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Dorsal zona incerta
Up to 3 mA, 60 us, 130 Hz deep brain stimulation
Device: Up to 3 mA, 60 us, 130 Hz deep brain stimulation
EXPERIMENTAL: Caudal zona incerta
Up to 3 mA, 60 us, 130 Hz deep brain stimulation
Device: Up to 3 mA, 60 us, 130 Hz deep brain stimulation
EXPERIMENTAL: 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.
Device: Empirical unblinded deep brain stimulation programming

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months
Time Frame: 3 months
At end of first randomised crossover trial period
3 months
Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months
Time Frame: 6 months
At end of second randomised crossover trial period
6 months
Change from baseline United Parkinsons Disease Rating Scale Part III at 12 months
Time Frame: 12 months
At end of non-randomised empirical deep brain stimulator programming period
12 months
Change from baseline Fahn Tolosa Marin tremor scale at 3 months
Time Frame: 3 months
At end of first randomised crossover trial period for tremor patients
3 months
Change from baseline Fahn Tolosa Marin tremor scale at 6 months
Time Frame: 6 months
At end of second randomised crossover trial period for tremor patients
6 months
Change from baseline Fahn Tolosa Marin tremor scale at 12 months
Time Frame: 12 months
At end of empirical deep brain stimulator programming period for tremor patients
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline ON-OFF diary at 3 months
Time Frame: 3 months
For Parkinson's disease
3 months
Change from baseline ON-OFF diary at 6 months
Time Frame: 6 months
For Parkinson's disease
6 months
Change from baseline ON-OFF diary at 12 months
Time Frame: 12 months
For Parkinson's disease
12 months
Adverse events
Time Frame: 12 months
Any adverse medical event from date of randomization until the date of first documented adverse event or date of death from any cause, whichever came first, assessed up to 12 months
12 months
Change from baseline Short form 36 at 3 months
Time Frame: 3 months
At end of first randomised crossover period
3 months
Change from baseline Short form 36 at 6 months
Time Frame: 6 months
At end of second randomised crossover period
6 months
Change from baseline Short form 36 at 12 months
Time Frame: 12 months
At end of empirical deep brain stimulator programming period
12 months
Change from baseline Parkinsons Disease Quality of Life 39 at 3 months
Time Frame: 3 months
At end of first randomised crossover period for Parkinsons disease
3 months
Change from baseline Parkinsons Disease Quality of Life 39 at 6 months
Time Frame: 6 months
At end of second randomised crossover period for Parkinsons disease
6 months
Change from baseline Parkinsons Disease Quality of Life 39 at 12 months
Time Frame: 12 months
At end of empirical deep brain stimulator programming period for Parkinsons disease
12 months
Change from baseline L-dopa equivalent dose at 3 months
Time Frame: 3 months
At end of first randomised crossover period for Parkinsons disease
3 months
Change from baseline L-dopa equivalent dose at 6 months
Time Frame: 3 months
At end of second randomised crossover period for Parkinsons disease
3 months
Change from baseline L-dopa equivalent dose at 12 months
Time Frame: 12 months
At end of empirical deep brain stimulator programming period for Parkinsons disease
12 months
Change from baseline neuropsychological battery at 3 months
Time Frame: 3 months
At end of first randomised crossover period
3 months
Change from baseline neuropsychological battery at 6 months
Time Frame: 6 months
At end of second randomised crossover period
6 months
Change from baseline neuropsychological battery at 12 months
Time Frame: 12 months
At end of empirical deep brain stimulator programming period
12 months
Change from baseline verbal fluency at 3 months
Time Frame: 3 months
At end of first randomised crossover period
3 months
Change from baseline verbal fluency at 6 months
Time Frame: 6 months
At end of second randomised crossover period
6 months
Change from baseline verbal fluency at 12 months
Time Frame: 12 months
At end of empirical deep brain stimulator programming period
12 months
Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months
Time Frame: 3 months
At end of first randomised crossover period
3 months
Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months
Time Frame: 6 months
At end of second randomised crossover period
6 months
Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months
Time Frame: 12 months
At end of empirical deep brain stimulator programming period
12 months
Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 3 months
Time Frame: 3 months
At end of first randomised crossover period for Parkinsons disease
3 months
Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 6 months
Time Frame: 6 months
At end of second randomised crossover period for Parkinsons disease
6 months
Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 12 months
Time Frame: 12 months
At end of empirical deep brain stimulator programming period for Parkinsons disease
12 months
Change from baseline Abnormal Involuntary Movement Scale at 3 months
Time Frame: 3 months
At end of first randomised crossover period for Parkinsons disease
3 months
Change from baseline Abnormal Involuntary Movement Scale at 6 months
Time Frame: 6 months
At end of second randomised crossover period for Parkinsons disease
6 months
Change from baseline Abnormal Involuntary Movement Scale at 12 months
Time Frame: 12 months
At end of empirical deep brain stimulator programming period for Parkinsons disease
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Western Australia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christopher Lind, MBChB, FRACS, The University of Western Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 14, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 14, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2012-039

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