Clinical trial NCT01945567: Randomised Crossover Trial of DBS of Differential PSA Regions in Parkinson's Disease and Tremor
Official title: Randomised Crossover Trial of Deep Brain Stimulation of Differential Posterior Subthalamic Area Regions in Parkinson's Disease and Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Tremor
Keywords: Parkinson's disease
Essential tremor
Tremor
Deep brain stimulation
Posterior subthalamic area
Zona incerta
Lead sponsor: The University of Western Australia
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from baseline United Parkinsons Disease Rating Scale Part III at 3 months
timeFrame: 3 months
measure: Change from baseline United Parkinsons Disease Rating Scale Part III at 6 months
timeFrame: 6 months
measure: Change from baseline United Parkinsons Disease Rating Scale Part III at 12 months
timeFrame: 12 months
measure: Change from baseline Fahn Tolosa Marin tremor scale at 3 months
timeFrame: 3 months
measure: Change from baseline Fahn Tolosa Marin tremor scale at 6 months
timeFrame: 6 months
measure: Change from baseline Fahn Tolosa Marin tremor scale at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Change from baseline ON-OFF diary at 3 months
timeFrame: 3 months
measure: Change from baseline ON-OFF diary at 6 months
timeFrame: 6 months
measure: Change from baseline ON-OFF diary at 12 months
timeFrame: 12 months
measure: Adverse events
timeFrame: 12 months
measure: Change from baseline Short form 36 at 3 months
timeFrame: 3 months
measure: Change from baseline Short form 36 at 6 months
timeFrame: 6 months
measure: Change from baseline Short form 36 at 12 months
timeFrame: 12 months
measure: Change from baseline Parkinsons Disease Quality of Life 39 at 3 months
timeFrame: 3 months
measure: Change from baseline Parkinsons Disease Quality of Life 39 at 6 months
timeFrame: 6 months
measure: Change from baseline Parkinsons Disease Quality of Life 39 at 12 months
timeFrame: 12 months
measure: Change from baseline L-dopa equivalent dose at 3 months
timeFrame: 3 months
measure: Change from baseline L-dopa equivalent dose at 6 months
timeFrame: 3 months
measure: Change from baseline L-dopa equivalent dose at 12 months
timeFrame: 12 months
measure: Change from baseline neuropsychological battery at 3 months
timeFrame: 3 months
measure: Change from baseline neuropsychological battery at 6 months
timeFrame: 6 months
measure: Change from baseline neuropsychological battery at 12 months
timeFrame: 12 months
measure: Change from baseline verbal fluency at 3 months
timeFrame: 3 months
measure: Change from baseline verbal fluency at 6 months
timeFrame: 6 months
measure: Change from baseline verbal fluency at 12 months
timeFrame: 12 months
measure: Change from baseline Mini-International Neuropsychiatric Interview Plus at 3 months
timeFrame: 3 months
measure: Change from baseline Mini-International Neuropsychiatric Interview Plus at 6 months
timeFrame: 6 months
measure: Change from baseline Mini-International Neuropsychiatric Interview Plus at 12 months
timeFrame: 12 months
measure: Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 3 months
timeFrame: 3 months
measure: Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 6 months
timeFrame: 6 months
measure: Change from baseline United Parkinsons Disease Rating Scale parts I, II, IV, V at 12 months
timeFrame: 12 months
measure: Change from baseline Abnormal Involuntary Movement Scale at 3 months
timeFrame: 3 months
measure: Change from baseline Abnormal Involuntary Movement Scale at 6 months
timeFrame: 6 months
measure: Change from baseline Abnormal Involuntary Movement Scale at 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
Study officials:
affiliation: The University of Western Australia
name: Christopher Lind, MBChB, FRACS
role: PRINCIPAL_INVESTIGATOR
References: