CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Frequency change to 60 Hz +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00993291
NCT00993291Phase 2Completed
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Effect of Frequency Change in Bilateral Subthalamic Nucleus (STN)-DBS on Gait Function in PD

Vanderbilt University·interventional·Posted Oct 12, 2009·Updated Jan 27, 2012

In Brief

A Phase 2 clinical trial evaluating Frequency change to 60 Hz and Frequency change to 130 Hz for Parkinson Disease. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2009
Enrollment StartNov 1, 2009
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.7 years ago

Interventions

Frequency change to 60 Hzprocedure

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

Frequency change to 130 Hzprocedure

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