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

Parkinson's Disease research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Parkinson's Disease

Tremor

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Device:Empirical unblinded deep brain stimulation programming

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Dorsal zona incertaUp to 3 mA, 60 us, 130 Hz deep brain stimulation

Caudal zona incertaUp to 3 mA, 60 us, 130 Hz deep brain stimulation

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

Study Status

Unknown status

Start Date: August 2012

Completed Date: February 2018

Phase: Phase 2

Type: Interventional

Design:

Primary Outcome: Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months

Secondary Outcome: Change from baseline ON-OFF diary at 3 months

Study sponsors, principal investigator, and references

Principal Investigator: Christopher Lind, MBChB, FRACS

Lead Sponsor: The University of Western Australia

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01945567

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