STEM-Parkinson's Disease

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

  • Parkinson Disease
  • Parkinson's Disease and Parkinsonism

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.