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Completed

NCT Number: NCT00993291

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

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Frequency change to 60 Hz

Procedure

60 Hz stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.

Other names: 60 Hertz

Frequency change to 130 Hz

Procedure

130 Hz Stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.

Other names: 130 Hz

Primary outcomes

  1. 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

Secondary outcomes

  1. Gait Velocity

    Time frame: 5 hours

    gait velocity measured as change from baseline in in CM/second

  2. Time to Walk 14 Meters

    Time frame: 5 hours

    Change in the time to walk 14 meters compared to baseline measured in seconds

Sponsors and collaborators

Lead sponsor

Vanderbilt University

Other

Registry information

Official study title

Effect of Frequency Change in Bilateral Subthalamic Nucleus (STN)-DBS on Gait Function in PD

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 12, 2009
Registry last updated
Jan 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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