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

The University of Western Australia

Status and phase: Completed; Phase 2

Conditions: Tremor; Parkinson's Disease

Treatments: Device: Empirical unblinded deep brain stimulation programming; Device: Up to 3 mA, 60 us, 130 Hz deep brain stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01945567

2012-039

Details and patient eligibility

About

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.

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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39 participants in 3 patient groups

Dorsal zona incerta

Experimental group

Description:

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

Treatment:

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

Caudal zona incerta

Experimental group

Description:

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

Treatment:

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

Empirical deep brain stimulation

Experimental group

Description:

Empirical unblinded deep brain stimulation programming using any posterior subthalamic area electrode contact(s) and stimulation parameters to optimise clinical outcome.

Treatment:

Device: Empirical unblinded deep brain stimulation programming