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Sponsor: Fortis Medical Devices Limited
Conditions: Parkinson's Disease With Freezing of Gait
Interventions: CueStim
Countries: United States
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
Sex: ALL
Age: 60 Years to 90 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Boca Raton, Florida, United States
- Daytona Beach, Florida, United States
- Atlanta, Georgia, United States
- Kansas City, Kansas, United States
- Portland, Oregon, United States
- Kirkland, Washington, United States