CueStim for Freezing of Gait in Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
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
Are You a Good Fit for This Trial?
This trial is for people with Parkinson's disease who experience freezing of gait (sudden inability to move while walking). Participants should be able to use a wearable device and complete daily diaries. Specific inclusion or exclusion details are not provided.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- CueStim
Trial Overview
The study tests two different modes of the cueStim wearable device, which aims to help reduce episodes where movement suddenly stops in Parkinson’s patients. Participants will be randomly assigned a mode and use the device during daily life for 4 weeks.
How Is the Trial Designed?
2
Treatment groups
Active Control
The first, unidentified mode delivers electrical stimulation to the legs to improve gait (i.e., reduce Freezing of Gait \[FoG\]) of patients with Parkinson's disease (PD). There are also 2 electrodes which connect the stimulators to the subject. Stimulators are attached to the thigh of each leg. The stimulators deliver sensory electrical stimulation (sES), a non-adaptive rhythmic cueing strategy consisting of a continuous series of biphasic electrical stimulation bursts, in an alternating rhythmic manner scaled to the patient's stride rate. Stimulation is customized to each patient prior to first-time use via a Clinician Tablet Controller. The Tablet Controller is used to program and to adjust device stimulation settings over time. The Stimulators' on-board electronics sense when the patient is sitting, has stopped walking or is attempting to walk and delivers stimulation only when the patient is actively walking or attempting to walk.
The second, unidentified mode is a modified version of the cueStim stimulator which uses a different mode of stimulation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fortis Medical Devices Limited
Lead Sponsor
Avania
Industry Sponsor
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