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

Phase 2CompletedNCT01945567

The University of Western Australia39 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Parkinson's Disease Tremor

Interventions

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

Empirical unblinded deep brain stimulation programmingDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Outcomes

Primary Outcomes

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

At end of first randomised crossover trial period

Time frame: 3 months

Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months

At end of second randomised crossover trial period

Time frame: 6 months

Change from baseline United Parkinsons Disease Rating Scale Part III at 12 months

At end of non-randomised empirical deep brain stimulator programming period

Time frame: 12 months

Change from baseline Fahn Tolosa Marin tremor scale at 3 months

At end of first randomised crossover trial period for tremor patients

Time frame: 3 months

Change from baseline Fahn Tolosa Marin tremor scale at 6 months

At end of second randomised crossover trial period for tremor patients

Time frame: 6 months

Change from baseline Fahn Tolosa Marin tremor scale at 12 months

At end of empirical deep brain stimulator programming period for tremor patients

Time frame: 12 months

Secondary Outcomes

Change from baseline ON-OFF diary at 3 months

For Parkinson's disease

Time frame: 3 months

Change from baseline ON-OFF diary at 6 months

For Parkinson's disease

Data from ClinicalTrials.gov

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Time frame: 6 months

Change from baseline ON-OFF diary at 12 months

For Parkinson's disease

Time frame: 12 months

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

Time frame: 12 months

Change from baseline Short form 36 at 3 months

At end of first randomised crossover period

Time frame: 3 months

Change from baseline Short form 36 at 6 months

At end of second randomised crossover period

Time frame: 6 months

Change from baseline Short form 36 at 12 months

At end of empirical deep brain stimulator programming period

Time frame: 12 months

Change from baseline Parkinsons Disease Quality of Life 39 at 3 months

At end of first randomised crossover period for Parkinsons disease

Time frame: 3 months

Change from baseline Parkinsons Disease Quality of Life 39 at 6 months

At end of second randomised crossover period for Parkinsons disease

Time frame: 6 months

Change from baseline Parkinsons Disease Quality of Life 39 at 12 months

At end of empirical deep brain stimulator programming period for Parkinsons disease

Time frame: 12 months

Change from baseline L-dopa equivalent dose at 3 months

At end of first randomised crossover period for Parkinsons disease

Time frame: 3 months

Change from baseline L-dopa equivalent dose at 6 months

At end of second randomised crossover period for Parkinsons disease

Time frame: 3 months

Change from baseline L-dopa equivalent dose at 12 months

At end of empirical deep brain stimulator programming period for Parkinsons disease

Time frame: 12 months

Change from baseline neuropsychological battery at 3 months

At end of first randomised crossover period

Time frame: 3 months

Change from baseline neuropsychological battery at 6 months

At end of second randomised crossover period

Time frame: 6 months

Change from baseline neuropsychological battery at 12 months

At end of empirical deep brain stimulator programming period

Time frame: 12 months

Change from baseline verbal fluency at 3 months

At end of first randomised crossover period

Time frame: 3 months

Change from baseline verbal fluency at 6 months

At end of second randomised crossover period

Time frame: 6 months

Change from baseline verbal fluency at 12 months

At end of empirical deep brain stimulator programming period

Time frame: 12 months

Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months

At end of first randomised crossover period

Time frame: 3 months

Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months

At end of second randomised crossover period

Time frame: 6 months

Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months

At end of empirical deep brain stimulator programming period

Time frame: 12 months

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

Time frame: 3 months

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

Time frame: 6 months

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

Time frame: 12 months

Change from baseline Abnormal Involuntary Movement Scale at 3 months

At end of first randomised crossover period for Parkinsons disease

Time frame: 3 months

Change from baseline Abnormal Involuntary Movement Scale at 6 months

At end of second randomised crossover period for Parkinsons disease

Time frame: 6 months

Change from baseline Abnormal Involuntary Movement Scale at 12 months

At end of empirical deep brain stimulator programming period for Parkinsons disease

Time frame: 12 months