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

NCT ID: NCT00993291

Last Updated: 2012-01-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-08-31

Brief Summary

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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

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Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Baseline frequency

Baseline DBS frequency

Group Type NO_INTERVENTION

Frequency change to 60 Hz

Intervention Type PROCEDURE

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

Frequency change to 130 Hz

Intervention Type PROCEDURE

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

Interventions

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Frequency change to 60 Hz

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

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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60 Hertz 130 Hz

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vanderbilt University

OTHER

Sponsor Role lead

Responsible Party

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Fenna Phibbs

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fenna T Phibbs, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt Univeristy

Locations

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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090873

Identifier Type: -

Identifier Source: org_study_id

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