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

Phase 1

Completed

• Conditions: Parkinson Disease
• Interventions: Procedure: Frequency change to 60 Hz; Procedure: Frequency change to 130 Hz

• Registration Number: NCT00993291
• Lead Sponsor: Vanderbilt University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-10-09
• Study First Posted: 2009-10-12
• Study Start: 2009-11
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2011-08-22
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-21
• Last Update Submitted: 2011-12-21
• Results First Posted: 2012-01-27
• Last Update Posted: 2012-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

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Exclusion Criteria

• See inclusion criteria.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Baseline frequency	Frequency change to 60 Hz	Baseline DBS frequency
Baseline frequency	Frequency change to 130 Hz	Baseline DBS frequency

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Gait Velocity	5 hours	gait velocity measured as change from baseline in in CM/second
Time to Walk 14 Meters	5 hours	Change in the time to walk 14 meters compared to baseline measured in seconds

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States