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

December 21, 2011 updated by: Fenna Phibbs, Vanderbilt University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 130 Hz

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Stride Length From Baseline
Time Frame: 1 hour
Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait Velocity
Time Frame: 5 hours
gait velocity measured as change from baseline in in CM/second
5 hours
Time to Walk 14 Meters
Time Frame: 5 hours
Change in the time to walk 14 meters compared to baseline measured in seconds
5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Investigators

  • Principal Investigator: Fenna T Phibbs, MD, Vanderbilt Univeristy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

October 8, 2009

First Submitted That Met QC Criteria

October 9, 2009

First Posted (Estimate)

October 12, 2009

Study Record Updates

Last Update Posted (Estimate)

January 27, 2012

Last Update Submitted That Met QC Criteria

December 21, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 090873

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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