STEM-Parkinson's Disease

Last updated: July 28, 2023
Sponsor: Scion NeuroStim
Overall Status: Active - Recruiting




Parkinson's Disease


Non-invasive brainstem stimulation

Clinical Study ID

  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria


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.

Study Design

Total Participants: 218
Treatment Group(s): 1
Primary Treatment: Non-invasive brainstem stimulation
Study Start date:
May 19, 2022
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • Movement Disorder Center of Arizona

    Scottsdale, Arizona 85258
    United States

    Active - Recruiting

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Active - Recruiting

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida 33486
    United States

    Active - Recruiting

  • Headlands Research Orlando

    Orlando, Florida 32819
    United States

    Active - Recruiting

  • USF Parkinson's Disease and Movement Disorders Center

    Tampa, Florida 33613
    United States

    Active - Recruiting

  • University of Kansas Medical Center - Parkinson's Disease Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Quest Research

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

  • Meridian Clinical Research

    Raleigh, North Carolina 27607
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Veracity Neuroscience

    Memphis, Tennessee 38157
    United States

    Active - Recruiting

  • Houston Methodist Neurological Institute

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Riverside Neurology Specialists

    Newport News, Virginia 23601
    United States

    Active - Recruiting

  • Inland Northwest Research

    Spokane, Washington 99202
    United States

    Active - Recruiting

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