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

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ClinicalTrials.gov Identifier: NCT01945567
Recruitment Status : Recruiting
First Posted : September 18, 2013
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Tremor Device: Up to 3 mA, 60 us, 130 Hz deep brain stimulation Device: Empirical unblinded deep brain stimulation programming Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised Crossover Trial of Deep Brain Stimulation of Differential Posterior Subthalamic Area Regions in Parkinson's Disease and Tremor
Study Start Date : August 2012
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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. 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


Secondary Outcome Measures :
  1. Change from baseline ON-OFF diary at 3 months [ Time Frame: 3 months ]
    For Parkinson's disease

  2. Change from baseline ON-OFF diary at 6 months [ Time Frame: 6 months ]
    For Parkinson's disease

  3. Change from baseline ON-OFF diary at 12 months [ Time Frame: 12 months ]
    For Parkinson's disease

  4. 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

  5. Change from baseline Short form 36 at 3 months [ Time Frame: 3 months ]
    At end of first randomised crossover period

  6. Change from baseline Short form 36 at 6 months [ Time Frame: 6 months ]
    At end of second randomised crossover period

  7. Change from baseline Short form 36 at 12 months [ Time Frame: 12 months ]
    At end of empirical deep brain stimulator programming period

  8. 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

  9. 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

  10. 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

  11. Change from baseline L-dopa equivalent dose at 3 months [ Time Frame: 3 months ]
    At end of first randomised crossover period for Parkinsons disease

  12. Change from baseline L-dopa equivalent dose at 6 months [ Time Frame: 3 months ]
    At end of second randomised crossover period for Parkinsons disease

  13. 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

  14. Change from baseline neuropsychological battery at 3 months [ Time Frame: 3 months ]
    At end of first randomised crossover period

  15. Change from baseline neuropsychological battery at 6 months [ Time Frame: 6 months ]
    At end of second randomised crossover period

  16. Change from baseline neuropsychological battery at 12 months [ Time Frame: 12 months ]
    At end of empirical deep brain stimulator programming period

  17. Change from baseline verbal fluency at 3 months [ Time Frame: 3 months ]
    At end of first randomised crossover period

  18. Change from baseline verbal fluency at 6 months [ Time Frame: 6 months ]
    At end of second randomised crossover period

  19. Change from baseline verbal fluency at 12 months [ Time Frame: 12 months ]
    At end of empirical deep brain stimulator programming period

  20. Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months [ Time Frame: 3 months ]
    At end of first randomised crossover period

  21. Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months [ Time Frame: 6 months ]
    At end of second randomised crossover period

  22. Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months [ Time Frame: 12 months ]
    At end of empirical deep brain stimulator programming period

  23. 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

  24. 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

  25. 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

  26. Change from baseline Abnormal Involuntary Movement Scale at 3 months [ Time Frame: 3 months ]
    At end of first randomised crossover period for Parkinsons disease

  27. Change from baseline Abnormal Involuntary Movement Scale at 6 months [ Time Frame: 6 months ]
    At end of second randomised crossover period for Parkinsons disease

  28. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01945567


Contacts
Contact: Christopher Lind, MBChB, FRACS +61 8 9346 2865 Christopher.Lind@health.wa.gov.au
Contact: Megan Thorburn, RN Megan.Thorburn@health.wa.gov.au

Locations
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Perth, Western Australia, Australia, 6009
Sponsors and Collaborators
The University of Western Australia
Investigators
Principal Investigator: Christopher Lind, MBChB, FRACS The University of Western Australia
More Information

Additional Information:
Responsible Party: Professor Christopher Lind, Professor, School of Surgery, The University of Western Australia
ClinicalTrials.gov Identifier: NCT01945567     History of Changes
Other Study ID Numbers: 2012-039
First Posted: September 18, 2013    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

Keywords provided by Professor Christopher Lind, The University of Western Australia:
Parkinson's disease
Essential tremor
Tremor
Deep brain stimulation
Posterior subthalamic area
Zona incerta

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Tremor
Dyskinesias
Neurologic Manifestations
Signs and Symptoms