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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by The University of Western Australia
Sponsor:
Information provided by (Responsible Party):
Professor Christopher Lind, The University of Western Australia
ClinicalTrials.gov Identifier:
NCT01945567
First received: September 14, 2013
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by The University of Western Australia:

Primary Outcome Measures:
  • Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    At end of empirical deep brain stimulator programming period for tremor patients


Secondary Outcome Measures:
  • Change from baseline ON-OFF diary at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    For Parkinson's disease

  • Change from baseline ON-OFF diary at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    For Parkinson's disease

  • Change from baseline ON-OFF diary at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    For Parkinson's disease

  • Adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    At end of first randomised crossover period

  • Change from baseline Short form 36 at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    At end of second randomised crossover period

  • Change from baseline Short form 36 at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    At end of first randomised crossover period for Parkinsons disease

  • Change from baseline L-dopa equivalent dose at 6 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    At end of second randomised crossover period for Parkinsons disease

  • Change from baseline L-dopa equivalent dose at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    At end of empirical deep brain stimulator programming period for Parkinsons disease

  • Change from baseline neuropsychological battery at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    At end of first randomised crossover period

  • Change from baseline neuropsychological battery at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    At end of second randomised crossover period

  • Change from baseline neuropsychological battery at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    At end of empirical deep brain stimulator programming period

  • Change from baseline verbal fluency at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    At end of first randomised crossover period

  • Change from baseline verbal fluency at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    At end of second randomised crossover period

  • Change from baseline verbal fluency at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    At end of empirical deep brain stimulator programming period

  • Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    At end of first randomised crossover period

  • Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    At end of second randomised crossover period

  • Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    At end of first randomised crossover period for Parkinsons disease

  • Change from baseline Abnormal Involuntary Movement Scale at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    At end of second randomised crossover period for Parkinsons disease

  • Change from baseline Abnormal Involuntary Movement Scale at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    At end of empirical deep brain stimulator programming period for Parkinsons disease


Estimated Enrollment: 50
Study Start Date: August 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: September 14, 2013
Last Updated: September 17, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on July 26, 2014