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Validation of cueStim for Reduction of Freezing of Gait in Parkinson's Disease

NCT07675408 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-30

No results posted yet for this 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

Conditions

  • Parkinson's Disease With Freezing of Gait

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Avania

    collaborator INDUSTRY

  • Fortis Medical Devices Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-02-28
Completion
2027-02-28

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 NCT07675408 on ClinicalTrials.gov