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

Prior treatment

• Previous use of cueing devices within the last 3 months

Other illness

• 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
• 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.

Other

• Atypical or secondary parkinsonism, including vascular parkinsonism
• 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
• Pregnant or breastfeeding women

• 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.