Randomised Crossover Trial of DBS of Differential PSA Regions in Parkinson's Disease and Tremor

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01945567
• Other study ID #: 2012-039
• Status: Completed
• Phase: Phase 2
• Start date: August 2012
• Est. completion date: August 30, 2020

Study information

• Verified date: May 2021
• Source: The University of Western Australia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease
• Tremor

Intervention

Device:
• Up to 3 mA, 60 us, 130 Hz deep brain stimulation

• Empirical unblinded deep brain stimulation programming

Locations

Country	Name	City	State
Australia	Sir Charles Gairdner Hospital	Perth	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
The University of Western Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months	At end of first randomised crossover trial period	3 months
Primary	Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months	At end of second randomised crossover trial period	6 months
Primary	Change from baseline United Parkinsons Disease Rating Scale Part III at 12 months	At end of non-randomised empirical deep brain stimulator programming period	12 months
Primary	Change from baseline Fahn Tolosa Marin tremor scale at 3 months	At end of first randomised crossover trial period for tremor patients	3 months
Primary	Change from baseline Fahn Tolosa Marin tremor scale at 6 months	At end of second randomised crossover trial period for tremor patients	6 months
Primary	Change from baseline Fahn Tolosa Marin tremor scale at 12 months	At end of empirical deep brain stimulator programming period for tremor patients	12 months
Secondary	Change from baseline ON-OFF diary at 3 months	For Parkinson's disease	3 months
Secondary	Change from baseline ON-OFF diary at 6 months	For Parkinson's disease	6 months
Secondary	Change from baseline ON-OFF diary at 12 months	For Parkinson's disease	12 months
Secondary	Adverse events	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	12 months
Secondary	Change from baseline Short form 36 at 3 months	At end of first randomised crossover period	3 months
Secondary	Change from baseline Short form 36 at 6 months	At end of second randomised crossover period	6 months
Secondary	Change from baseline Short form 36 at 12 months	At end of empirical deep brain stimulator programming period	12 months
Secondary	Change from baseline Parkinsons Disease Quality of Life 39 at 3 months	At end of first randomised crossover period for Parkinsons disease	3 months
Secondary	Change from baseline Parkinsons Disease Quality of Life 39 at 6 months	At end of second randomised crossover period for Parkinsons disease	6 months
Secondary	Change from baseline Parkinsons Disease Quality of Life 39 at 12 months	At end of empirical deep brain stimulator programming period for Parkinsons disease	12 months
Secondary	Change from baseline L-dopa equivalent dose at 3 months	At end of first randomised crossover period for Parkinsons disease	3 months
Secondary	Change from baseline L-dopa equivalent dose at 6 months	At end of second randomised crossover period for Parkinsons disease	3 months
Secondary	Change from baseline L-dopa equivalent dose at 12 months	At end of empirical deep brain stimulator programming period for Parkinsons disease	12 months
Secondary	Change from baseline neuropsychological battery at 3 months	At end of first randomised crossover period	3 months
Secondary	Change from baseline neuropsychological battery at 6 months	At end of second randomised crossover period	6 months
Secondary	Change from baseline neuropsychological battery at 12 months	At end of empirical deep brain stimulator programming period	12 months
Secondary	Change from baseline verbal fluency at 3 months	At end of first randomised crossover period	3 months
Secondary	Change from baseline verbal fluency at 6 months	At end of second randomised crossover period	6 months
Secondary	Change from baseline verbal fluency at 12 months	At end of empirical deep brain stimulator programming period	12 months
Secondary	Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months	At end of first randomised crossover period	3 months
Secondary	Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months	At end of second randomised crossover period	6 months
Secondary	Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months	At end of empirical deep brain stimulator programming period	12 months
Secondary	Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 3 months	At end of first randomised crossover period for Parkinsons disease	3 months
Secondary	Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 6 months	At end of second randomised crossover period for Parkinsons disease	6 months
Secondary	Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 12 months	At end of empirical deep brain stimulator programming period for Parkinsons disease	12 months
Secondary	Change from baseline Abnormal Involuntary Movement Scale at 3 months	At end of first randomised crossover period for Parkinsons disease	3 months
Secondary	Change from baseline Abnormal Involuntary Movement Scale at 6 months	At end of second randomised crossover period for Parkinsons disease	6 months
Secondary	Change from baseline Abnormal Involuntary Movement Scale at 12 months	At end of empirical deep brain stimulator programming period for Parkinsons disease	12 months

External Links

•   Surgical NeuroDiscovery Group