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

Starting soon · Not applicable

Conditions studied: Parkinson's Disease With Freezing of Gait

In brief

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

Key facts

Study ID

NCT07675408

Run by

Fortis Medical Devices Limited

People needed

60

Starts

2026-10-01

Expected to finish

2027-02-01

Last updated by the study team

2026-06-30

Who can join

Age: 60 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Arrow Clinical Trials — Daytona Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Kansas — Kansas City, Kansas, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Evergreen Health Research Program — Kirkland, Washington, United States

Full record on ClinicalTrials.gov

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