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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 : Unknown
Verified December 2014 by Professor Christopher Lind, The University of Western Australia.
Recruitment status was:  Recruiting
First Posted : September 18, 2013
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
Professor Christopher Lind, The University of Western Australia

September 14, 2013
September 18, 2013
December 31, 2014
August 2012
August 2017   (Final data collection date for primary outcome measure)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
Same as current
Complete list of historical versions of study NCT01945567 on ClinicalTrials.gov Archive Site
  • Change from baseline ON-OFF diary at 3 months [ Time Frame: 3 months ]
    For Parkinson's disease
  • Change from baseline ON-OFF diary at 6 months [ Time Frame: 6 months ]
    For Parkinson's disease
  • Change from baseline ON-OFF diary at 12 months [ Time Frame: 12 months ]
    For Parkinson's disease
  • 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
  • Change from baseline Short form 36 at 3 months [ Time Frame: 3 months ]
    At end of first randomised crossover period
  • Change from baseline Short form 36 at 6 months [ Time Frame: 6 months ]
    At end of second randomised crossover period
  • Change from baseline Short form 36 at 12 months [ Time Frame: 12 months ]
    At end of empirical deep brain stimulator programming period
  • 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
  • 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
  • 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
  • Change from baseline L-dopa equivalent dose at 3 months [ Time Frame: 3 months ]
    At end of first randomised crossover period for Parkinsons disease
  • Change from baseline L-dopa equivalent dose at 6 months [ Time Frame: 3 months ]
    At end of second randomised crossover period for Parkinsons disease
  • 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
  • Change from baseline neuropsychological battery at 3 months [ Time Frame: 3 months ]
    At end of first randomised crossover period
  • Change from baseline neuropsychological battery at 6 months [ Time Frame: 6 months ]
    At end of second randomised crossover period
  • Change from baseline neuropsychological battery at 12 months [ Time Frame: 12 months ]
    At end of empirical deep brain stimulator programming period
  • Change from baseline verbal fluency at 3 months [ Time Frame: 3 months ]
    At end of first randomised crossover period
  • Change from baseline verbal fluency at 6 months [ Time Frame: 6 months ]
    At end of second randomised crossover period
  • Change from baseline verbal fluency at 12 months [ Time Frame: 12 months ]
    At end of empirical deep brain stimulator programming period
  • Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months [ Time Frame: 3 months ]
    At end of first randomised crossover period
  • Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months [ Time Frame: 6 months ]
    At end of second randomised crossover period
  • Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 12 months ]
    At end of empirical deep brain stimulator programming period for Parkinsons disease
  • Change from baseline Abnormal Involuntary Movement Scale at 3 months [ Time Frame: 3 months ]
    At end of first randomised crossover period for Parkinsons disease
  • Change from baseline Abnormal Involuntary Movement Scale at 6 months [ Time Frame: 6 months ]
    At end of second randomised crossover period for Parkinsons disease
  • 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
Same as current
Not Provided
Not Provided
 
Randomised Crossover Trial of Deep Brain Stimulation of Differential Posterior Subthalamic Area Regions in Parkinson's Disease and Tremor
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
  • Parkinson's Disease
  • Tremor
  • Device: Up to 3 mA, 60 us, 130 Hz deep brain stimulation
  • Device: Empirical unblinded deep brain stimulation programming
  • Experimental: Dorsal zona incerta
    Up to 3 mA, 60 us, 130 Hz deep brain stimulation
    Intervention: 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
    Intervention: 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.
    Intervention: Device: Empirical unblinded deep brain stimulation programming
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
Same as current
February 2018
August 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
 
NCT01945567
2012-039
No
Not Provided
Not Provided
Professor Christopher Lind, The University of Western Australia
The University of Western Australia
Not Provided
Principal Investigator: Christopher Lind, MBChB, FRACS The University of Western Australia
The University of Western Australia
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP