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Deep Brain Stimulation (DBS) Frequency Effects on Gait in Parkinson's Disease(PD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fenna Phibbs, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00993291
First received: October 8, 2009
Last updated: December 21, 2011
Last verified: December 2011
History of Changes

October 8, 2009
December 21, 2011
November 2009
August 2011   (final data collection date for primary outcome measure)
Change in Stride Length From Baseline [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length
Change in stride length [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00993291 on ClinicalTrials.gov Archive Site
  • Gait Velocity [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
    gait velocity measured as change from baseline in in CM/second
  • Time to Walk 14 Meters [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
    Change in the time to walk 14 meters compared to baseline measured in seconds
  • Gait velocity [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
  • Time to walk 14 meters. [ Time Frame: 5 hours ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Deep Brain Stimulation (DBS) Frequency Effects on Gait in Parkinson's Disease(PD)
Effect of Frequency Change in Bilateral Subthalamic Nucleus (STN)-DBS on Gait Function in PD

In this study the investigators will evaluate the effect of both low and high frequency Deep Brain stimulation of the subthalamic nucleus (STN) in Parkinson's patients who have noted a change in their walking. The investigators' hypothesis is:

  1. Stimulation at 60 Hertz (Hz) is associated with improved gait with increased stride length and faster time on the Stand walk sit test.
  2. There is no worsening of the Unified Parkinson's Disease Rating Scale (UPDRS) at 60 Hz.
Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Parkinson Disease
  • Procedure: Frequency change to 60 Hz
    60 Hz stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.
    Other Name: 60 Hertz
  • Procedure: Frequency change to 130 Hz
    130 Hz Stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.
    Other Name: 130 Hz
No Intervention: Baseline frequency
Baseline DBS frequency
Interventions:
  • Procedure: Frequency change to 60 Hz
  • Procedure: Frequency change to 130 Hz
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Be a patient at the Vanderbilt Movement Disorders clinic.
  • Report a change in their gait.
  • Be able to walk independently when off PD medications for 12-16 hours.
  • Have a stable dose of PD medications for the prior three months .
  • Not cognitively impaired, so as to give informed consent.
  • MMSE > 24.

Exclusion Criteria:

  • See inclusion criteria.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00993291
090873
Yes
Fenna Phibbs, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Fenna T Phibbs, MD Vanderbilt Univeristy
Vanderbilt University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP