Deep Brain Stimulation (DBS) Frequency Effects on Gait in Parkinson's Disease(PD)
|ClinicalTrials.gov Identifier: NCT00993291|
Recruitment Status : Completed
First Posted : October 12, 2009
Results First Posted : January 27, 2012
Last Update Posted : January 27, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Parkinson Disease||Procedure: Frequency change to 60 Hz Procedure: Frequency change to 130 Hz||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Effect of Frequency Change in Bilateral Subthalamic Nucleus (STN)-DBS on Gait Function in PD|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
No Intervention: Baseline frequency
Baseline DBS frequency
Procedure: Frequency change to 60 Hz
60 Hz stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.
Other Name: 60 HertzProcedure: Frequency change to 130 Hz
130 Hz Stimulation for one hour, done twice over the 5 hour study period in a randomized blinded fashion.
Other Name: 130 Hz
- 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
- Gait Velocity [ Time Frame: 5 hours ]gait velocity measured as change from baseline in in CM/second
- Time to Walk 14 Meters [ Time Frame: 5 hours ]Change in the time to walk 14 meters compared to baseline measured in seconds
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00993291
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Fenna T Phibbs, MD||Vanderbilt Univeristy|