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
  Purpose

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.

Condition Intervention Phase
Parkinson Disease
Procedure: Frequency change to 60 Hz
Procedure: Frequency change to 130 Hz
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Frequency Change in Bilateral Subthalamic Nucleus (STN)-DBS on Gait Function in PD

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: November 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Baseline frequency
Baseline DBS frequency
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00993291

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Fenna T Phibbs, MD Vanderbilt Univeristy
  More Information

No publications provided

Responsible Party: Fenna Phibbs, PI, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00993291     History of Changes
Other Study ID Numbers: 090873
Study First Received: October 8, 2009
Results First Received: August 22, 2011
Last Updated: December 21, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Parkinson's Disease
DBS
Frequency
Deep brain stimulation

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 April 23, 2014