Comparison of Constant Current to Constant Voltage Stimulation in Subthalamic Deep Brain Stimulation for Parkinson's Disease

NCT01423565 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2015-03-18

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Zvi Israel, MBBS · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Israel

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01423565 on ClinicalTrials.gov