Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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: 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, 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.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Other
Investigational Treatment 1
Investigational treatment mode (stimulation pattern) 1
  • Device: Non-invasive brainstem stimulation
    Study participants will self-administer ~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive brainstem modulation device. The device has been deemed to be a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.
Other
Investigational Treatment 2
Investigational treatment mode (stimulation pattern) 2
  • Device: Non-invasive brainstem stimulation
    Study participants will self-administer ~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive brainstem modulation device. The device has been deemed to be a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.

Recruiting Locations

University of Kansas Medical Center - Parkinson's Disease Center
Kansas City, Kansas 66160
Contact:
Alicia Alejandre
913-588-6924
aalejandre@kumc.edu

More Details

Status
Recruiting
Sponsor
Scion NeuroStim

Study Contact

Kara Richardson
(984) 884-1020
krichardson@scionneurostim.com

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.