STEM-PD Randomized Controlled Trial
STEM-PD Randomized Controlled Trial
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
 PD.
Up to 220 participants will first 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 (84 days). The RCT will have 6 study visits completed at both the study center
 and the participant's home by video call.
Inclusion Criteria:

 -  Adult participants (aged 18 - 85 years inclusive)

 -  Have been diagnosed with PD according to the UK Brain Bank Criteria

 -  Participants must have demonstrated a positive response to medications to treat the
 motor symptoms of PD and have been treated with these medications for minimum of three
 years prior to the screening visit.

 -  Report limitation to activities of daily living

 -  Participants must be able and willing to consent to participate in the study.

 -  Participants must be willing and able to comply with study requirements.

 -  Participants and investigators must expect that the participant will be able to remain
 on a stable regimen of concomitant therapies used for the management of PD motor and
 non-motor symptoms and not to introduce new medications used to treat motor or
 non-motor symptoms associated with PD during the trial.

 -  Participants must have at minimum a moderate burden of NMS.

 -  Participants must have a study partner (defined as someone who sees the participant
 for more than one hour a day, 3x per week) that is willing to consent and participate
 in the trial.

 -  Participants must 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.

 -  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 been previously diagnosed with vestibular dysfunction.

 -  Have active ear infections, perforated tympanic membrane or labyrinthitis, as
 identified by a general ear examination performed by medically qualified
 Investigators.

 -  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.