Deep Brain Stimulation (DBS) Frequency Effects on Gait in Parkinson's Disease(PD)
Effect of Frequency Change in Bilateral Subthalamic Nucleus (STN)-DBS on Gait Function in PD
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 parkinson-disease
Started Nov 2009
Typical duration for phase_1 parkinson-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 8, 2009
CompletedFirst Posted
Study publicly available on registry
October 12, 2009
CompletedStudy Start
First participant enrolled
November 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
January 27, 2012
CompletedJanuary 27, 2012
December 1, 2011
1.7 years
October 8, 2009
August 22, 2011
December 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
1 hour
Secondary Outcomes (2)
Gait Velocity
5 hours
Time to Walk 14 Meters
5 hours
Study Arms (1)
Baseline frequency
NO INTERVENTIONBaseline DBS frequency
Interventions
60 Hz stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.
130 Hz Stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vanderbilt University
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Fenna Phibbs M.D.
- Organization
- Vanderbilt University
Study Officials
- PRINCIPAL INVESTIGATOR
Fenna T Phibbs, MD
Vanderbilt Univeristy
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
October 8, 2009
First Posted
October 12, 2009
Study Start
November 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
January 27, 2012
Results First Posted
January 27, 2012
Record last verified: 2011-12