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.
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
Eligibility
Sex
ALL
Min age
60 Years
Max age
90 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Demonstrate Superiority — 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.
Trial sites (6)
Facility
City
Region
Status
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton
Florida
Arrow Clinical Trials
Daytona Beach
Florida
Emory University
Atlanta
Georgia
University of Kansas
Kansas City
Kansas
Oregon Health and Science University
Portland
Oregon
Evergreen Health Research Program
Kirkland
Washington
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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