Validation of cueStim for Reduction of Freezing of Gait in Parkinson's Disease
Condition(s) studied
Investigational drug(s) / intervention(s)
CueStim: Enrolled patients will be assigned to one of two modes and will be blinded to their assignment. The Device will be worn for four weeks throughout the patient's daily life. The patient will complete daily diary entries, periodically check in with the clinical staff, and complete questionnaires related to the impact of freezing of gait and Parkinson's Disease on daily life and function.
Study summary
The goal of this clinical trial is to learn if the cueStim device can reduce the duration of freezing of gait (FoG) that occurs in patients with Parkinson's Disease. The study will compare two modes of operation of the cueStim device; both modes of operation use the same wearable device. The purpose of the study is to compare how the two modes affect symptoms across study participants. Because this is a research study, it is not yet known whether either mode reduces symptoms.
Participants will:
* Be randomized to one of the two modes available on the cueStim device
* Wear the device for 4 weeks as they go about their daily life
* Complete daily diary entries to document symptoms, falls and overall experience
* Check-in with the clinical site throughout participation
* Complete a final follow-up visit
Eligibility
Primary outcome measure(s)
- Demonstrate Superiority — From enrollment to the end of treatment at 4 weeks
The main goal of this study is to determine whether one mode of the cueStim device works better than another. After four weeks of use, it will be compared how well each mode reduces the duration of freezing of gait in patients with Parkinson's Disease who are taking medication, while they are wearing the device.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | |
| Arrow Clinical Trials | Daytona Beach | Florida | |
| Emory University | Atlanta | Georgia | |
| University of Kansas | Kansas City | Kansas | |
| Oregon Health and Science University | Portland | Oregon | |
| Evergreen Health Research Program | Kirkland | Washington |
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07675408 on ClinicalTrials.gov ↗ ← All trials in the USA