Randomised Crossover Trial of DBS of Differential PSA Regions in Parkinson's Disease and Tremor
- Conditions
- Parkinson's DiseaseTremor
- Interventions
- Device: Up to 3 mA, 60 us, 130 Hz deep brain stimulationDevice: Empirical unblinded deep brain stimulation programming
- Registration Number
- NCT01945567
- Lead Sponsor
- The University of Western Australia
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dorsal zona incerta Up to 3 mA, 60 us, 130 Hz deep brain stimulation Up to 3 mA, 60 us, 130 Hz deep brain stimulation Empirical deep brain stimulation Empirical unblinded deep brain stimulation programming Empirical unblinded deep brain stimulation programming using any posterior subthalamic area electrode contact(s) and stimulation parameters to optimise clinical outcome. Caudal zona incerta Up to 3 mA, 60 us, 130 Hz deep brain stimulation Up to 3 mA, 60 us, 130 Hz deep brain stimulation
- Primary Outcome Measures
Name Time Method Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months 6 months At end of second randomised crossover trial period
Change from baseline Fahn Tolosa Marin tremor scale at 12 months 12 months At end of empirical deep brain stimulator programming period for tremor patients
Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months 3 months At end of first randomised crossover trial period
Change from baseline United Parkinsons Disease Rating Scale Part III at 12 months 12 months At end of non-randomised empirical deep brain stimulator programming period
Change from baseline Fahn Tolosa Marin tremor scale at 3 months 3 months At end of first randomised crossover trial period for tremor patients
Change from baseline Fahn Tolosa Marin tremor scale at 6 months 6 months At end of second randomised crossover trial period for tremor patients
- Secondary Outcome Measures
Name Time Method Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months 3 months At end of first randomised crossover period
Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 3 months 3 months At end of first randomised crossover period for Parkinsons disease
Change from baseline ON-OFF diary at 3 months 3 months For Parkinson's disease
Change from baseline Short form 36 at 3 months 3 months At end of first randomised crossover period
Change from baseline Short form 36 at 6 months 6 months At end of second randomised crossover period
Change from baseline L-dopa equivalent dose at 6 months 3 months At end of second randomised crossover period for Parkinsons disease
Change from baseline neuropsychological battery at 3 months 3 months At end of first randomised crossover period
Change from baseline neuropsychological battery at 6 months 6 months At end of second randomised crossover period
Change from baseline verbal fluency at 3 months 3 months At end of first randomised crossover period
Change from baseline verbal fluency at 12 months 12 months At end of empirical deep brain stimulator programming period
Change from baseline Abnormal Involuntary Movement Scale at 6 months 6 months At end of second randomised crossover period for Parkinsons disease
Change from baseline ON-OFF diary at 12 months 12 months For Parkinson's disease
Adverse events 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 Parkinsons Disease Quality of Life 39 at 3 months 3 months At end of first randomised crossover period for Parkinsons disease
Change from baseline L-dopa equivalent dose at 12 months 12 months At end of empirical deep brain stimulator programming period for Parkinsons disease
Change from baseline Parkinsons Disease Quality of Life 39 at 6 months 6 months At end of second randomised crossover period for Parkinsons disease
Change from baseline Parkinsons Disease Quality of Life 39 at 12 months 12 months At end of empirical deep brain stimulator programming period for Parkinsons disease
Change from baseline ON-OFF diary at 6 months 6 months For Parkinson's disease
Change from baseline neuropsychological battery at 12 months 12 months At end of empirical deep brain stimulator programming period
Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months 6 months At end of second randomised crossover period
Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months 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 12 months 12 months At end of empirical deep brain stimulator programming period for Parkinsons disease
Change from baseline Short form 36 at 12 months 12 months At end of empirical deep brain stimulator programming period
Change from baseline L-dopa equivalent dose at 3 months 3 months At end of first randomised crossover period for Parkinsons disease
Change from baseline verbal fluency at 6 months 6 months At end of second randomised crossover period
Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 6 months 6 months At end of second randomised crossover period for Parkinsons disease
Change from baseline Abnormal Involuntary Movement Scale at 12 months 12 months At end of empirical deep brain stimulator programming period for Parkinsons disease
Change from baseline Abnormal Involuntary Movement Scale at 3 months 3 months At end of first randomised crossover period for Parkinsons disease
Trial Locations
- Locations (1)
Sir Charles Gairdner Hospital
🇦🇺Perth, Western Australia, Australia