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cueStim for Freezing of Gait in Parkinson's Disease

This study is testing a device called cueStim to see if it can reduce "freezing of gait" (FoG) in people with Parkinson's Disease. FoG is when your feet feel stuck to the ground, making it hard to walk. The study will compare two different ways the cueStim device can work. You would wear the device for four weeks during your daily life and keep a diary of your symptoms. Researchers want to find out if one of these modes is better at reducing how long FoG episodes last. To join, you need to be between 60 and 90 years old, have Parkinson's Disease confirmed by a doctor, be able to walk 12 meters without a walking aid (a cane is okay), and be taking levodopa medication. The study aims to show that one mode of cueStim works better than the other after four weeks of use.

Study design
This is a randomized, double-blind study with 60 participants. You would be assigned to one of two cueStim device modes, and neither you nor the evaluators will know which mode you are using.
What's involved
You would wear the cueStim device for four weeks at home, complete daily diary entries, and have check-ins with clinical staff. There will be an in-clinic screening visit, a baseline visit for device setup, and a final follow-up visit.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is measured at the end of treatment after four weeks. The record does not specify follow-up beyond this point.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07675408

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

Not Yet Recruiting
NAAges 60–90InterventionalSupportive care
Fortis Medical Devices Limited
~60 participants
Updated 2026-06-30 on ClinicalTrials.gov
What's tested:CueStim

At a glance

Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demonstrate Superiority
Measured over From enrollment to the end of treatment at 4 weeks

Conditions

Parkinson's Disease With Freezing of Gait

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Parkinson Disease

NCT07675408

Where you'd take part

This study runs at 6 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Arrow Clinical Trials

    Daytona Beach, Floridastudy coordinator listed

  • Emory University

    Atlanta, Georgiastudy coordinator listed

  • Evergreen Health Research Program

    Kirkland, Washingtonstudy coordinator listed

  • Oregon Health and Science University

    Portland, Oregonstudy coordinator listed

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Floridastudy coordinator listed

  • University of Kansas

    Kansas City, Kansasstudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Research Coordinator
[email protected]
561-392-1818 · ext. 2
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Demonstrate SuperiorityFrom 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.