Phase 2
Completed N=20
Deep Brain Stimulation (DBS) Frequency Effects on Gait in Parkinson's Disease(PD)
Source: ClinicalTrials.gov NCT00993291 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jan 2012
Primary outcomePrimary: Change in Stride Length From Baseline — 1.19 CM
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Stride Length From Baseline |
1.19 | — |
| SECONDARY Gait Velocity |
— | — |
| SECONDARY Time to Walk 14 Meters |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT00993291). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.