Overview
This is a double-blinded, controlled, randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Parkinson's disease.
Description
Up to 218 participants will enter the double-blinded, controlled, randomized clinical trial (RCT) and will self-administer treatments twice daily in the home setting over a period of 12 weeks following a 4 week baseline period. The RCT will have 6 study visits: 3 visits at the study center and 3 visits completed in the participant's home by video call.
Eligibility
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 one year 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.
- 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 , who are not
abstinent or exclusively in same sex relationships must:
- Test negative for pregnancy as indicated by a negative urine pregnancy test
- 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, or a transient ischemic attack within the past 6 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.