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Parkinson's DiseasePhase 2NCT01945567

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

A Phase 2 study testing Up to 3 mA, 60 us, 130 Hz deep brain stimulation and Empirical unblinded deep brain stimulation programming in people with Parkinson's Disease and Tremor, run by The University of Western Australia at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson's Disease, Tremor
What is being tested?
Up to 3 mA, 60 us, 130 Hz deep brain stimulation and Empirical unblinded deep brain stimulation programming
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
1 siteAustralia
Study dates
Aug 2012to 30 Aug 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Australia1 site

  • Sir Charles Gairdner Hospital

    Perth, Western Australia, 6009

Other trials in Australia

About this study

Official title: 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.

Read the 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.

Being tested
Up to 3 mA, 60 us, 130 Hz deep brain stimulation, Empirical unblinded deep brain stimulation programming
Keywords
Parkinson's disease, Essential tremor, Tremor, Deep brain stimulation, Posterior subthalamic area, Zona incerta
Medical subject headings
Parkinson Disease, Tremor, Essential Tremor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Up to 3 mA, 60 us, 130 Hz deep brain stimulationDevice

  • Empirical unblinded deep brain stimulation programmingDevice

Study groups in NCT01945567
Study groupRoleWhat they receive
Dorsal zona incertaExperimentalUp to 3 mA, 60 us, 130 Hz deep brain stimulation
Receives: Device: Up to 3 mA, 60 us, 130 Hz deep brain stimulation
Caudal zona incertaExperimentalUp to 3 mA, 60 us, 130 Hz deep brain stimulation
Receives: Device: Up to 3 mA, 60 us, 130 Hz deep brain stimulation
Empirical deep brain stimulationExperimentalEmpirical unblinded deep brain stimulation programming using any posterior subthalamic area electrode contact(s) and stimulation parameters to optimise clinical outcome.
Receives: Device: Empirical unblinded deep brain stimulation programming

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months

    At end of first randomised crossover trial period

    Measured: 3 months

  2. Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months

    At end of second randomised crossover trial period

    Measured: 6 months

  3. Change from baseline United Parkinsons Disease Rating Scale Part III at 12 months

    At end of non-randomised empirical deep brain stimulator programming period

    Measured: 12 months

  4. Change from baseline Fahn Tolosa Marin tremor scale at 3 months

    At end of first randomised crossover trial period for tremor patients

    Measured: 3 months

  5. Change from baseline Fahn Tolosa Marin tremor scale at 6 months

    At end of second randomised crossover trial period for tremor patients

    Measured: 6 months

  6. Change from baseline Fahn Tolosa Marin tremor scale at 12 months

    At end of empirical deep brain stimulator programming period for tremor patients

    Measured: 12 months

Secondary outcomes (28)

  1. Change from baseline ON-OFF diary at 3 months

    For Parkinson's disease

    Measured: 3 months

  2. Change from baseline ON-OFF diary at 6 months

    For Parkinson's disease

    Measured: 6 months

  3. Change from baseline ON-OFF diary at 12 months

    For Parkinson's disease

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. Change from baseline Short form 36 at 3 months

    At end of first randomised crossover period

    Measured: 3 months

  6. Change from baseline Short form 36 at 6 months

    At end of second randomised crossover period

    Measured: 6 months

  7. Change from baseline Short form 36 at 12 months

    At end of empirical deep brain stimulator programming period

    Measured: 12 months

  8. Change from baseline Parkinsons Disease Quality of Life 39 at 3 months

    At end of first randomised crossover period for Parkinsons disease

    Measured: 3 months

  9. Change from baseline Parkinsons Disease Quality of Life 39 at 6 months

    At end of second randomised crossover period for Parkinsons disease

    Measured: 6 months

  10. Change from baseline Parkinsons Disease Quality of Life 39 at 12 months

    At end of empirical deep brain stimulator programming period for Parkinsons disease

    Measured: 12 months

  11. Change from baseline L-dopa equivalent dose at 3 months

    At end of first randomised crossover period for Parkinsons disease

    Measured: 3 months

  12. Change from baseline L-dopa equivalent dose at 6 months

    At end of second randomised crossover period for Parkinsons disease

    Measured: 3 months

  13. Change from baseline L-dopa equivalent dose at 12 months

    At end of empirical deep brain stimulator programming period for Parkinsons disease

    Measured: 12 months

  14. Change from baseline neuropsychological battery at 3 months

    At end of first randomised crossover period

    Measured: 3 months

  15. Change from baseline neuropsychological battery at 6 months

    At end of second randomised crossover period

    Measured: 6 months

  16. Change from baseline neuropsychological battery at 12 months

    At end of empirical deep brain stimulator programming period

    Measured: 12 months

  17. Change from baseline verbal fluency at 3 months

    At end of first randomised crossover period

    Measured: 3 months

  18. Change from baseline verbal fluency at 6 months

    At end of second randomised crossover period

    Measured: 6 months

  19. Change from baseline verbal fluency at 12 months

    At end of empirical deep brain stimulator programming period

    Measured: 12 months

  20. Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months

    At end of first randomised crossover period

    Measured: 3 months

  21. Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months

    At end of second randomised crossover period

    Measured: 6 months

  22. Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months

    At end of empirical deep brain stimulator programming period

    Measured: 12 months

  23. 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

    Measured: 3 months

  24. 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

    Measured: 6 months

  25. 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

    Measured: 12 months

  26. Change from baseline Abnormal Involuntary Movement Scale at 3 months

    At end of first randomised crossover period for Parkinsons disease

    Measured: 3 months

  27. Change from baseline Abnormal Involuntary Movement Scale at 6 months

    At end of second randomised crossover period for Parkinsons disease

    Measured: 6 months

  28. Change from baseline Abnormal Involuntary Movement Scale at 12 months

    At end of empirical deep brain stimulator programming period for Parkinsons disease

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2013 (estimated)
  2. Study startAug 2012
  3. Primary completion30 Aug 2019
  4. Study completion30 Aug 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01945567
Sponsor's protocol ID
2012-039
Status last verified
May 2021
First submitted
14 Sep 2013
Last updated
18 May 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Up to 3 mA, 60 us, 130 Hz deep brain stimulation and Empirical unblinded deep brain stimulation programming in people with Parkinson's Disease and Tremor, run by The University of Western Australia at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01945567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.

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