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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01945567
Registration number
NCT01945567
Ethics application status
Date submitted
14/09/2013
Date registered
18/09/2013
Date last updated
18/05/2021
Titles & IDs
Public title
Randomised Crossover Trial of DBS of Differential PSA Regions in Parkinson's Disease and Tremor
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Scientific title
Randomised Crossover Trial of Deep Brain Stimulation of Differential Posterior Subthalamic Area Regions in Parkinson's Disease and Tremor
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Secondary ID [1]
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2012-039
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease
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Tremor
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Condition category
Condition code
Neurological
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Parkinson's disease
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Devices - Up to 3 mA, 60 us, 130 Hz deep brain stimulation
Treatment: Devices - Empirical unblinded deep brain stimulation programming
Experimental: Dorsal zona incerta - 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
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.
Treatment: Devices: Up to 3 mA, 60 us, 130 Hz deep brain stimulation
Treatment: Devices: Empirical unblinded deep brain stimulation programming
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months
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Assessment method [1]
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At end of first randomised crossover trial period
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Timepoint [1]
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3 months
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Primary outcome [2]
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Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months
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Assessment method [2]
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At end of second randomised crossover trial period
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Timepoint [2]
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6 months
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Primary outcome [3]
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Change from baseline United Parkinsons Disease Rating Scale Part III at 12 months
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Assessment method [3]
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At end of non-randomised empirical deep brain stimulator programming period
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Timepoint [3]
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12 months
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Primary outcome [4]
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Change from baseline Fahn Tolosa Marin tremor scale at 3 months
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Assessment method [4]
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At end of first randomised crossover trial period for tremor patients
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Timepoint [4]
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3 months
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Primary outcome [5]
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Change from baseline Fahn Tolosa Marin tremor scale at 6 months
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Assessment method [5]
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At end of second randomised crossover trial period for tremor patients
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Timepoint [5]
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6 months
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Primary outcome [6]
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Change from baseline Fahn Tolosa Marin tremor scale at 12 months
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Assessment method [6]
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At end of empirical deep brain stimulator programming period for tremor patients
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Timepoint [6]
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12 months
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Secondary outcome [1]
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Change from baseline ON-OFF diary at 3 months
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Assessment method [1]
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For Parkinson's disease
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Timepoint [1]
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3 months
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Secondary outcome [2]
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Change from baseline ON-OFF diary at 6 months
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Assessment method [2]
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For Parkinson's disease
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Timepoint [2]
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6 months
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Secondary outcome [3]
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Change from baseline ON-OFF diary at 12 months
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Assessment method [3]
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For Parkinson's disease
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Timepoint [3]
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12 months
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Secondary outcome [4]
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Adverse events
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Assessment method [4]
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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
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Timepoint [4]
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12 months
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Secondary outcome [5]
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Change from baseline Short form 36 at 3 months
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Assessment method [5]
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At end of first randomised crossover period
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Timepoint [5]
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3 months
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Secondary outcome [6]
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Change from baseline Short form 36 at 6 months
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Assessment method [6]
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At end of second randomised crossover period
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Timepoint [6]
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6 months
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Secondary outcome [7]
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Change from baseline Short form 36 at 12 months
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Assessment method [7]
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At end of empirical deep brain stimulator programming period
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Timepoint [7]
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12 months
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Secondary outcome [8]
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Change from baseline Parkinsons Disease Quality of Life 39 at 3 months
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Assessment method [8]
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At end of first randomised crossover period for Parkinsons disease
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Timepoint [8]
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3 months
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Secondary outcome [9]
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Change from baseline Parkinsons Disease Quality of Life 39 at 6 months
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Assessment method [9]
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At end of second randomised crossover period for Parkinsons disease
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Timepoint [9]
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6 months
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Secondary outcome [10]
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Change from baseline Parkinsons Disease Quality of Life 39 at 12 months
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Assessment method [10]
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At end of empirical deep brain stimulator programming period for Parkinsons disease
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Timepoint [10]
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12 months
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Secondary outcome [11]
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Change from baseline L-dopa equivalent dose at 3 months
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Assessment method [11]
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At end of first randomised crossover period for Parkinsons disease
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Timepoint [11]
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3 months
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Secondary outcome [12]
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Change from baseline L-dopa equivalent dose at 6 months
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Assessment method [12]
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At end of second randomised crossover period for Parkinsons disease
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Timepoint [12]
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3 months
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Secondary outcome [13]
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Change from baseline L-dopa equivalent dose at 12 months
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Assessment method [13]
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At end of empirical deep brain stimulator programming period for Parkinsons disease
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Timepoint [13]
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12 months
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Secondary outcome [14]
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Change from baseline neuropsychological battery at 3 months
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Assessment method [14]
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At end of first randomised crossover period
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Timepoint [14]
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3 months
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Secondary outcome [15]
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Change from baseline neuropsychological battery at 6 months
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Assessment method [15]
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At end of second randomised crossover period
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Timepoint [15]
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6 months
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Secondary outcome [16]
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Change from baseline neuropsychological battery at 12 months
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Assessment method [16]
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At end of empirical deep brain stimulator programming period
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Timepoint [16]
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12 months
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Secondary outcome [17]
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Change from baseline verbal fluency at 3 months
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Assessment method [17]
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At end of first randomised crossover period
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Timepoint [17]
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3 months
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Secondary outcome [18]
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Change from baseline verbal fluency at 6 months
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Assessment method [18]
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At end of second randomised crossover period
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Timepoint [18]
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6 months
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Secondary outcome [19]
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Change from baseline verbal fluency at 12 months
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Assessment method [19]
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At end of empirical deep brain stimulator programming period
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Timepoint [19]
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12 months
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Secondary outcome [20]
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Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months
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Assessment method [20]
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At end of first randomised crossover period
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Timepoint [20]
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3 months
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Secondary outcome [21]
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Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months
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Assessment method [21]
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At end of second randomised crossover period
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Timepoint [21]
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6 months
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Secondary outcome [22]
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Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months
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Assessment method [22]
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At end of empirical deep brain stimulator programming period
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Timepoint [22]
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12 months
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Secondary outcome [23]
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Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 3 months
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Assessment method [23]
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At end of first randomised crossover period for Parkinsons disease
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Timepoint [23]
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3 months
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Secondary outcome [24]
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Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 6 months
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Assessment method [24]
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At end of second randomised crossover period for Parkinsons disease
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Timepoint [24]
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6 months
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Secondary outcome [25]
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Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 12 months
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Assessment method [25]
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At end of empirical deep brain stimulator programming period for Parkinsons disease
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Timepoint [25]
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12 months
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Secondary outcome [26]
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Change from baseline Abnormal Involuntary Movement Scale at 3 months
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Assessment method [26]
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At end of first randomised crossover period for Parkinsons disease
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Timepoint [26]
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3 months
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Secondary outcome [27]
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Change from baseline Abnormal Involuntary Movement Scale at 6 months
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Assessment method [27]
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At end of second randomised crossover period for Parkinsons disease
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Timepoint [27]
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6 months
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Secondary outcome [28]
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Change from baseline Abnormal Involuntary Movement Scale at 12 months
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Assessment method [28]
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At end of empirical deep brain stimulator programming period for Parkinsons disease
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Timepoint [28]
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12 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
30/08/2020
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Sample size
Target
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Accrual to date
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Final
39
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Sir Charles Gairdner Hospital - Perth
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Recruitment postcode(s) [1]
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6009 - Perth
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Western Australia
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01945567
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Christopher Lind, MBChB, FRACS
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Address
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The University of Western Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01945567
Download to PDF