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

Primary Purpose

Parkinson Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Frequency change to 60 Hz

Frequency change to 130 Hz

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's Disease, DBS, Frequency, Deep brain stimulation

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Vanderbilt University

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Baseline frequency

Arm Description

Baseline DBS frequency

Outcomes

Primary Outcome Measures

Change in Stride Length From Baseline

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

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

Time to Walk 14 Meters

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

Full Information

NCT ID

NCT00993291

First Posted

October 8, 2009

Last Updated

December 21, 2011

Sponsor

Vanderbilt University

1. Study Identification

Unique Protocol Identification Number

NCT00993291

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: Stimulation at 60 Hertz (Hz) is associated with improved gait with increased stride length and faster time on the Stand walk sit test. There is no worsening of the Unified Parkinson's Disease Rating Scale (UPDRS) at 60 Hz.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

Keywords

Parkinson's Disease, DBS, Frequency, Deep brain stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

N/A

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Baseline frequency

Arm Type

No Intervention

Arm Description

Baseline DBS frequency

Intervention Type

Procedure

Intervention Name(s)

Frequency change to 60 Hz

Other Intervention Name(s)

60 Hertz

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Frequency change to 130 Hz

Other Intervention Name(s)

130 Hz

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Stride Length From Baseline

Description

Evaluation performed after DBS frequency setting changed for one hour, compared to the subject's baseline DBS frequency stride length

Time Frame

1 hour

Secondary Outcome Measure Information:

Title

Gait Velocity

Description

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

Time Frame

5 hours

Title

Time to Walk 14 Meters

Description

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

Time Frame

5 hours

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fenna T Phibbs, MD

Organizational Affiliation

Vanderbilt Univeristy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

12. IPD Sharing Statement

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

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