Randomised Crossover Trial of Deep Brain Stimulation of Differential Posterior Subthalamic Area Regions in Parkinson's Disease and Tremor
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- The University of Western Australia
- Enrollment
- 39
- Locations
- 1
- Primary Endpoint
- Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Professor Christopher Lind
Professor, School of Surgery
The University of Western Australia
Eligibility 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
Outcomes
Primary Outcomes
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 Fahn Tolosa Marin tremor scale at 12 months
Time Frame: 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
Time Frame: 3 months
At end of first 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
Secondary Outcomes
- Change from baseline ON-OFF diary at 3 months(3 months)
- Change from baseline Short form 36 at 3 months(3 months)
- Change from baseline Short form 36 at 6 months(6 months)
- Change from baseline L-dopa equivalent dose at 6 months(3 months)
- Change from baseline neuropsychological battery at 3 months(3 months)
- Change from baseline neuropsychological battery at 6 months(6 months)
- Change from baseline verbal fluency at 3 months(3 months)
- Change from baseline verbal fluency at 12 months(12 months)
- Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months(3 months)
- Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 3 months(3 months)
- Change from baseline Abnormal Involuntary Movement Scale at 6 months(6 months)
- Change from baseline ON-OFF diary at 12 months(12 months)
- Adverse events(12 months)
- Change from baseline Parkinsons Disease Quality of Life 39 at 3 months(3 months)
- Change from baseline L-dopa equivalent dose at 12 months(12 months)
- Change from baseline ON-OFF diary at 6 months(6 months)
- Change from baseline Parkinsons Disease Quality of Life 39 at 6 months(6 months)
- Change from baseline Parkinsons Disease Quality of Life 39 at 12 months(12 months)
- Change from baseline neuropsychological battery at 12 months(12 months)
- Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months(6 months)
- Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months(12 months)
- Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 12 months(12 months)
- Change from baseline Short form 36 at 12 months(12 months)
- Change from baseline L-dopa equivalent dose at 3 months(3 months)
- Change from baseline verbal fluency at 6 months(6 months)
- Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 6 months(6 months)
- Change from baseline Abnormal Involuntary Movement Scale at 12 months(12 months)
- Change from baseline Abnormal Involuntary Movement Scale at 3 months(3 months)