STEM-Parkinson's Disease

This is an interventional treatment trial for Parkinson Disease focused on measuring Randomized Controlled Trial (RCT), Medical Devices, Non-Motor Symptoms (NMS), Non-Invasive Brain Stimulation Read More

Inclusion Criteria:

• Adult participants (aged 18 - 85 years inclusive)
• Diagnosed with Parkinson's disease according to the UK Brain Bank Criteria
• Demonstrates a positive response to oral anti-Parkinsonian medications (i.e. dopamine replacement therapies) and treated with these medications for minimum of three years prior to the screening visit
• Report limitation to activities of daily living (e.g., writing, walking, bathing, dressing, eating, toileting, etc.)
• Able and willing to consent to participate in the study.
• Willing and able to comply with study requirements.
• Anticipate being able to remain on a stable regimen of medications used for the management of PD motor and non-motor symptoms and not to introduce new medications used to treat symptoms associated with PD during the trial.
• Fully vaccinated from COVID-19 (at least 2 weeks from their final dose) with one of the current World Health Organization evaluated vaccines, prior to Screen.
• Have at minimum a moderate burden of non-motor symptoms associated with Parkinson's disease
• Have a study partner (defined as someone who sees the participant for more than one hour a day, 3 times per week) that is willing to consent and participate in the trial.
• Have capabilities to use and access smartphones and or tablets for the collection of some study data.
• Must be willing to answer questions related to sexual interest, arousal, and performance in an interview with study staff.

Exclusion Criteria:

• Participant anticipates being unable to attend all visits and complete all study activities.

• Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the study trial. Women of child-bearing potential (i.e., are not yet 3 years removed from their first menopausal symptom), who are not abstinent or exclusively in same sex relationships must:

  1. Test negative for pregnancy as indicated by a negative urine pregnancy test
  2. Agree to use an approved contraception method for the entirety of the trial
• Have a history or prior diagnosis of dementia or evidence of dementia at study screen.
• Have experienced a myocardial infarction, angina, or stroke within the past 12 months.
• Are receiving deep brain stimulation therapy.
• Are treated with a pump for continuous delivery of dopamine replacement medication.
• Use apomorphine rescue.
• Have received MRI guided high intensity focused ultrasound within the past 12 months.
• Experience frequent falls.
• Work night shifts
• Use a hearing aid that is implanted or that cannot be easily removed and replaced.
• Have a cochlear implant.
• Have chronic (>3 months) tinnitus.
• Have previously been diagnosed with traumatic brain injury with ongoing sequalae.
• Have been diagnosed with a co-morbid neurological disorder that may present with symptoms overlapping with PD (e.g., stroke, brain tumor, epilepsy, Alzheimer's disease, multiple sclerosis, amyotrophic lateral sclerosis, atypical Parkinsonism or aneurysm)
• Have unresolved complications from a previous surgical procedure at the baseline visits, such as swelling or persistent pain, that requires medical intervention.
• Have active ear infections, or other significant ear problems.
• Have a recent history of frequent ear infections (≥ 1 per year over the past two years)
• Are currently enrolled or have participated in another interventional clinical trial within the last 30 days.
• Have had eye surgery within the previous three months or ear surgery within the previous six months.
• Have planned surgery scheduled to occur during the study that requires sedation and/or would typically be followed with a prescription for pain management.