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Completed

NCT Number: NCT01945567

Randomised Crossover Trial of DBS of Differential PSA 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.

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyskinesias Essential Tremor Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurologic Manifestations Parkinson Disease Parkinsonian Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Synucleinopathies Tremor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sir Charles Gairdner Hospital

Perth, Western Australia, 6009, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Empirical unblinded deep brain stimulation programming

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

The University of Western Australia

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2020
First posted
Sep 18, 2013
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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