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A System to Help With Freezing of Gait in Parkinson's Patients

NCT07542743 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-21

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if the ParkinSense system, a customizable, multimodal, and adaptable cueing system, can assist with freezing of gait (FOG) in patients with Parkinson's disease. The main question it aims to answer is: is the percent of time spent frozen reduced when using the system compared to not using the system? Participants will be asked to take part in a single-visit laboratory study where they will wear the system in a controlled environment, followed by a two weeks of home use.

Conditions

  • Freezing of Gait Symptoms in Parkinson Disease

Interventions

DEVICE

ParkinSense System

The noninvasive, body-worn ParkinSense system is intended help patients with Parkinson's prevent freezing of gait (FOG) and resume ambulation when FOG occurs. The system provides multiple modes of cueing, offers extensive cue personalization, and automatically detects FOG and issues one or more cues that have been tailored to an individual when FOG is detected.

Sponsors & Collaborators

  • National Institute on Aging (NIA)

    collaborator NIH

  • University of Virginia

    collaborator OTHER

  • Barron Associates, Inc.

    lead INDUSTRY

Principal Investigators

  • Brian Clark · Barron Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542743 on ClinicalTrials.gov