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

June 26, 2026 updated by: Fortis Medical Devices Limited

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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 / visits consists of:

  • In-clinic Screening visit to ensure eligibility
  • Baseline visit for device setup and training (may be combined with screening visit)
  • "Home" (unsupervised at and out of the home) use of the device for four (4) weeks) as the patient goes about their daily life
  • End-of-treatment Follow-up visit

The primary objective of this clinical investigation is to determine if one mode of treatment demonstrates superiority after four weeks of device use, in reducing the duration of FoG, while the device is being worn by patients with PD receiving medication.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Parkinson's Disease and Movement Disorders Center of Boca Raton
        • Principal Investigator:
          • Stuart Isaacson, MD
        • Contact:
      • Daytona Beach, Florida, United States, 32117
        • Arrow Clinical Trials
        • Principal Investigator:
          • David Billmeier, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University
        • Contact:
        • Principal Investigator:
          • Lucas McKay, PhD MSCR
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas
        • Contact:
        • Principal Investigator:
          • Kelvin Au, MD, FRCPC
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
        • Principal Investigator:
          • Martina Mancini, PhD
        • Contact:
    • Washington
      • Kirkland, Washington, United States, 98034

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)
  • Satisfactory standard neurological examination, including completion of MDS- UPDRS I, II, III and IV by study clinician
  • PTF ≥20% during the baseline in-clinic FoG Provocation Test (conducted without the device) as determined by the centralized blinded video analysis using the FoG Switch tool by trained personnel independent of site investigators.

Exclusion Criteria

  • Atypical or secondary parkinsonism, including vascular parkinsonism
  • History of dementia, severe depression, psychosis, or active hallucinations
  • History of migraines, tinnitus, seizures or sensory issues
  • Other neurological or orthopedic impairment significantly affecting gait
  • Previous use of cueing devices within the last 3 months
  • Use of implanted electronic devices, including deep brain stimulation (DBS)
  • Use of assistive devices incompatible with the device (DBS users will be excluded
  • Is participating in another clinical trial during the study period
  • Any condition that, in the investigator's opinion, makes the participant unsuitable
  • As per medical records, any of the following identified within 3 months: myocardial infarction, hospitalization for unstable angina, stroke, coronary artery bypass graft, percutaneous coronary intervention, implantation or use of a cardiac resynchronization therapy device, active treatment for cancer or other malignant disease, uncontrolled congestive heart disease (NYHA class >3), acute psychosis or major psychiatric disorders or continued substance abuse.
  • Pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: First mode of cueStim

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.
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.
Active Comparator: Second mode of cueStim
The second, unidentified mode is a modified version of the cueStim stimulator which uses a different mode of stimulation.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demonstrate Superiority
Time Frame: 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.
From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fortis Medical Devices Limited

Collaborators

Avania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

June 26, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

June 30, 2026

Last Update Submitted That Met QC Criteria

June 26, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cueStim-PD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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