Text Size

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Israel Zvi, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01423565
First received: August 23, 2011
Last updated: November 24, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Parkinson's Disease
 Device: Deep Brain Stimulation (Medtronic, Activa PC)

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
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)
Arms Assigned Interventions
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
Other Names:
  • Medtronic
  • Activa PC

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic Parkinson's disease
  • Subthalamic Deep Brain Stimulation Surgery

Exclusion Criteria:

  • Any patient not meeting the inclusion criteria
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423565

Locations
Israel
Hadassah University Hospital
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Study Director: Zvi Israel, MBBS Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Israel Zvi, Dr. Zvi Israel, Director, Functional Neurosurgery, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01423565     History of Changes
Other Study ID Numbers: 386150-HMO-CTIL
Study First Received: August 23, 2011
Last Updated: November 24, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Deep Brain Stimulation
Parkinson's Disease
Subthalamic Nucleus
Constant Current

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on June 17, 2013