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

Primary Purpose

Parkinson's Disease, Tremor

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Up to 3 mA, 60 us, 130 Hz deep brain stimulation
Empirical unblinded deep brain stimulation programming
Sponsored by
The University of Western Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Essential tremor, Tremor, Deep brain stimulation, Posterior subthalamic area, Zona incerta

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sir Charles Gairdner Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Dorsal zona incerta

Caudal zona incerta

Empirical deep brain stimulation

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months
At end of first randomised crossover trial period
Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months
At end of second randomised crossover trial period
Change from baseline United Parkinsons Disease Rating Scale Part III at 12 months
At end of non-randomised empirical deep brain stimulator programming period
Change from baseline Fahn Tolosa Marin tremor scale at 3 months
At end of first randomised crossover trial period for tremor patients
Change from baseline Fahn Tolosa Marin tremor scale at 6 months
At end of second randomised crossover trial period for tremor patients
Change from baseline Fahn Tolosa Marin tremor scale at 12 months
At end of empirical deep brain stimulator programming period for tremor patients

Secondary Outcome Measures

Change from baseline ON-OFF diary at 3 months
For Parkinson's disease
Change from baseline ON-OFF diary at 6 months
For Parkinson's disease
Change from baseline ON-OFF diary at 12 months
For Parkinson's disease
Adverse events
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
Change from baseline Short form 36 at 3 months
At end of first randomised crossover period
Change from baseline Short form 36 at 6 months
At end of second randomised crossover period
Change from baseline Short form 36 at 12 months
At end of empirical deep brain stimulator programming period
Change from baseline Parkinsons Disease Quality of Life 39 at 3 months
At end of first randomised crossover period for Parkinsons disease
Change from baseline Parkinsons Disease Quality of Life 39 at 6 months
At end of second randomised crossover period for Parkinsons disease
Change from baseline Parkinsons Disease Quality of Life 39 at 12 months
At end of empirical deep brain stimulator programming period for Parkinsons disease
Change from baseline L-dopa equivalent dose at 3 months
At end of first randomised crossover period for Parkinsons disease
Change from baseline L-dopa equivalent dose at 6 months
At end of second randomised crossover period for Parkinsons disease
Change from baseline L-dopa equivalent dose at 12 months
At end of empirical deep brain stimulator programming period for Parkinsons disease
Change from baseline neuropsychological battery at 3 months
At end of first randomised crossover period
Change from baseline neuropsychological battery at 6 months
At end of second randomised crossover period
Change from baseline neuropsychological battery at 12 months
At end of empirical deep brain stimulator programming period
Change from baseline verbal fluency at 3 months
At end of first randomised crossover period
Change from baseline verbal fluency at 6 months
At end of second randomised crossover period
Change from baseline verbal fluency at 12 months
At end of empirical deep brain stimulator programming period
Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months
At end of first randomised crossover period
Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months
At end of second randomised crossover period
Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months
At end of empirical deep brain stimulator programming period
Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 3 months
At end of first randomised crossover period for Parkinsons disease
Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 6 months
At end of second randomised crossover period for Parkinsons disease
Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 12 months
At end of empirical deep brain stimulator programming period for Parkinsons disease
Change from baseline Abnormal Involuntary Movement Scale at 3 months
At end of first randomised crossover period for Parkinsons disease
Change from baseline Abnormal Involuntary Movement Scale at 6 months
At end of second randomised crossover period for Parkinsons disease
Change from baseline Abnormal Involuntary Movement Scale at 12 months
At end of empirical deep brain stimulator programming period for Parkinsons disease

Full Information

First Posted
September 14, 2013
Last Updated
May 13, 2021
Sponsor
The University of Western Australia
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1. Study Identification

Unique Protocol Identification Number
NCT01945567
Brief Title
Randomised Crossover Trial of DBS of Differential PSA Regions in Parkinson's Disease and Tremor
Official Title
Randomised Crossover Trial of Deep Brain Stimulation of Differential Posterior Subthalamic Area Regions in Parkinson's Disease and Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 2012 (Actual)
Primary Completion Date
August 30, 2019 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Western Australia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Tremor
Keywords
Parkinson's disease, Essential tremor, Tremor, Deep brain stimulation, Posterior subthalamic area, Zona incerta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dorsal zona incerta
Arm Type
Experimental
Arm Description
Up to 3 mA, 60 us, 130 Hz deep brain stimulation
Arm Title
Caudal zona incerta
Arm Type
Experimental
Arm Description
Up to 3 mA, 60 us, 130 Hz deep brain stimulation
Arm Title
Empirical deep brain stimulation
Arm Type
Experimental
Arm Description
Empirical unblinded deep brain stimulation programming using any posterior subthalamic area electrode contact(s) and stimulation parameters to optimise clinical outcome.
Intervention Type
Device
Intervention Name(s)
Up to 3 mA, 60 us, 130 Hz deep brain stimulation
Intervention Type
Device
Intervention Name(s)
Empirical unblinded deep brain stimulation programming
Primary Outcome Measure Information:
Title
Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months
Description
At end of first randomised crossover trial period
Time Frame
3 months
Title
Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months
Description
At end of second randomised crossover trial period
Time Frame
6 months
Title
Change from baseline United Parkinsons Disease Rating Scale Part III at 12 months
Description
At end of non-randomised empirical deep brain stimulator programming period
Time Frame
12 months
Title
Change from baseline Fahn Tolosa Marin tremor scale at 3 months
Description
At end of first randomised crossover trial period for tremor patients
Time Frame
3 months
Title
Change from baseline Fahn Tolosa Marin tremor scale at 6 months
Description
At end of second randomised crossover trial period for tremor patients
Time Frame
6 months
Title
Change from baseline Fahn Tolosa Marin tremor scale at 12 months
Description
At end of empirical deep brain stimulator programming period for tremor patients
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change from baseline ON-OFF diary at 3 months
Description
For Parkinson's disease
Time Frame
3 months
Title
Change from baseline ON-OFF diary at 6 months
Description
For Parkinson's disease
Time Frame
6 months
Title
Change from baseline ON-OFF diary at 12 months
Description
For Parkinson's disease
Time Frame
12 months
Title
Adverse events
Description
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
Time Frame
12 months
Title
Change from baseline Short form 36 at 3 months
Description
At end of first randomised crossover period
Time Frame
3 months
Title
Change from baseline Short form 36 at 6 months
Description
At end of second randomised crossover period
Time Frame
6 months
Title
Change from baseline Short form 36 at 12 months
Description
At end of empirical deep brain stimulator programming period
Time Frame
12 months
Title
Change from baseline Parkinsons Disease Quality of Life 39 at 3 months
Description
At end of first randomised crossover period for Parkinsons disease
Time Frame
3 months
Title
Change from baseline Parkinsons Disease Quality of Life 39 at 6 months
Description
At end of second randomised crossover period for Parkinsons disease
Time Frame
6 months
Title
Change from baseline Parkinsons Disease Quality of Life 39 at 12 months
Description
At end of empirical deep brain stimulator programming period for Parkinsons disease
Time Frame
12 months
Title
Change from baseline L-dopa equivalent dose at 3 months
Description
At end of first randomised crossover period for Parkinsons disease
Time Frame
3 months
Title
Change from baseline L-dopa equivalent dose at 6 months
Description
At end of second randomised crossover period for Parkinsons disease
Time Frame
3 months
Title
Change from baseline L-dopa equivalent dose at 12 months
Description
At end of empirical deep brain stimulator programming period for Parkinsons disease
Time Frame
12 months
Title
Change from baseline neuropsychological battery at 3 months
Description
At end of first randomised crossover period
Time Frame
3 months
Title
Change from baseline neuropsychological battery at 6 months
Description
At end of second randomised crossover period
Time Frame
6 months
Title
Change from baseline neuropsychological battery at 12 months
Description
At end of empirical deep brain stimulator programming period
Time Frame
12 months
Title
Change from baseline verbal fluency at 3 months
Description
At end of first randomised crossover period
Time Frame
3 months
Title
Change from baseline verbal fluency at 6 months
Description
At end of second randomised crossover period
Time Frame
6 months
Title
Change from baseline verbal fluency at 12 months
Description
At end of empirical deep brain stimulator programming period
Time Frame
12 months
Title
Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months
Description
At end of first randomised crossover period
Time Frame
3 months
Title
Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months
Description
At end of second randomised crossover period
Time Frame
6 months
Title
Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months
Description
At end of empirical deep brain stimulator programming period
Time Frame
12 months
Title
Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 3 months
Description
At end of first randomised crossover period for Parkinsons disease
Time Frame
3 months
Title
Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 6 months
Description
At end of second randomised crossover period for Parkinsons disease
Time Frame
6 months
Title
Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 12 months
Description
At end of empirical deep brain stimulator programming period for Parkinsons disease
Time Frame
12 months
Title
Change from baseline Abnormal Involuntary Movement Scale at 3 months
Description
At end of first randomised crossover period for Parkinsons disease
Time Frame
3 months
Title
Change from baseline Abnormal Involuntary Movement Scale at 6 months
Description
At end of second randomised crossover period for Parkinsons disease
Time Frame
6 months
Title
Change from baseline Abnormal Involuntary Movement Scale at 12 months
Description
At end of empirical deep brain stimulator programming period for Parkinsons disease
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Lind, MBChB, FRACS
Organizational Affiliation
The University of Western Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sir Charles Gairdner Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia

12. IPD Sharing Statement

Learn more about this trial

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

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