Comparison of Constant Current to Constant Voltage Stimulation in Subthalamic Deep Brain Stimulation for Parkinson's Disease
HYPOTHESIS: Constant current stimulation for STN DBS will allow better and more stable control of Parkinson's disease symptoms than constant voltage stimulation.
Subthalamic nucleus (STN) deep brain stimulation (DBS) is an established therapy for advanced Parkinson's disease (PD). Two types of implantable pulse generators (IPGs) are available, differing on whether voltage or electrical current is controlled. Constant current IPGs provide a specific electrical current and will automatically adjust the voltage depending on the impedance, while the current applied by constant voltage IPGs will depend on the tissue impedance that may change over time. No study has compared the clinical differences of these two electronic modalities.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comparison of Constant Current to Constant Voltage Stimulation in Subthalamic DBS for Parkinson's Disease|
- Impact of constant current on motor effects of STN DBS [ Time Frame: 1 month ] [ Designated as safety issue: No ]To assess any clinical impact of changing the electronic modality of IPGs from constant - voltage to constant - current in patients with advanced PD after STN stimulation in terms of motor examination according to the Unified Parkinson's Disease Rating Scale (UPDRS) III.
- Impact of constant current on psychocognitive affective status [ Time Frame: 1 month ] [ Designated as safety issue: No ]To assess the clinical impact of changing the electronic modality of IPGs from constant - voltage to constant - current in patients with advance PD after STN in terms of cognitive function, behavior, mood, quality of life and emotional processing according to the UPDRS I, UPDRS II, Hamilton Rating Scale for Depression (HAM-D17), Beck Depression Inventory (BDI), Clinical Global Inventory (CGI), Parkinson's disease questionnaire (PDQ-39), Addenbrooke's Cognitive Examination (ACE), Frontal Assessment Battery (FAB) and Hebrew version of the Montreal Affective Voices paradigm.
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||March 2012|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
|Experimental: Deep Brain Stimulation||
Device: Deep Brain Stimulation (Medtronic, Activa PC)
Following subthalamic nucleus deep brain stimulation patients will be randomized to receive either constant current or constant voltage stimulation and subsequently "crossed over" to receive the other type of stimulation
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01423565
|Hadassah University Hospital|
|Jerusalem, Israel, 91120|
|Study Director:||Zvi Israel, MBBS||Hadassah Medical Organization|