Comparison of Constant Current to Constant Voltage Stimulation in Subthalamic Deep Brain Stimulation for Parkinson's Disease
1 other identifier
interventional
8
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2011
CompletedFirst Posted
Study publicly available on registry
August 26, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMarch 18, 2015
March 1, 2015
6 months
August 23, 2011
March 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Impact of constant current on motor effects of STN DBS
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.
1 month
Secondary Outcomes (1)
Impact of constant current on psychocognitive affective status
1 month
Study Arms (1)
Deep Brain Stimulation
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Idiopathic Parkinson's disease
- Subthalamic Deep Brain Stimulation Surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hadassah University Hospital
Jerusalem, 91120, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zvi Israel, MBBS
Hadassah Medical Organization
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr. Zvi Israel, Director, Functional Neurosurgery
Study Record Dates
First Submitted
August 23, 2011
First Posted
August 26, 2011
Study Start
September 1, 2011
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
March 18, 2015
Record last verified: 2015-03