Validation of cueStim for Reduction of Freezing of Gait in Parkinson's Disease
Fortis Medical Devices Limited
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
Description
This is a prospective, randomized, double-blind, parallel group, multicenter, pivotal clinical trial to validate the use of cueStim for reduction of duration of FoG in Parkinson's patients. Enrolled subjects will be randomized 1:1 to two different modes of treatment. All subjects will be blinded to the study hypothesis. The clinician will not be blinded; however, specialists who will evaluate the outcome will be blinded. Enrolled subjects will be provided with training on the device during a clinic visit, and phone support is available throughout the home treatment duration. Study procedures…
Eligibility
- Age range
- 60–90 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 60-90 years, inclusive * Diagnosis of idiopathic PD, confirmed by a neurologist/Medical Doctor (MD), medical records, and verified during a post consent in-clinic evaluation by a trained MD * Patients can walk 12 meters without a walking aid (cane permitted during daily life) * The patient is using levodopa treatment. PD medications are stable, with no changes in PD-related medications for at least four weeks prior to screening visit, and stable dosing expected for duration of the study * Score greater or equal to 22 on the Montreal Cognitive Assessment (MoCA) * Sati…
Interventions
- DeviceCueStim
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.
Locations (6)
- Parkinson's Disease and Movement Disorders Center of Boca RatonBoca Raton, Florida
- Arrow Clinical TrialsDaytona Beach, Florida
- Emory UniversityAtlanta, Georgia
- University of KansasKansas City, Kansas
- Oregon Health and Science UniversityPortland, Oregon
- Evergreen Health Research ProgramKirkland, Washington