STEM-Parkinson's Disease

Completed · Not applicable

Conditions studied: Parkinson Disease, Parkinson's Disease and Parkinsonism

In brief

This is a double-blinded, controlled, and randomized clinical trial (RCT) to establish the safety and efficacy of a non-invasive neuromodulation device for treating symptoms associated with Parkinson's disease.

Key facts

Study ID

NCT04797611

Run by

Scion NeuroStim

People needed

188

Starts

2022-05-19

Expected to finish

2024-12-06

Last updated by the study team

2025-05-13

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adult participants (aged 18 - 85 years inclusive)
• Diagnosed with Parkinson's disease according to the UK Brain Bank Criteria (allowing for an exclusion in Step 2 for "more than one affected relative").
• Demonstrates a sustained, positive response to dopamine replacement therapies (DRTs) (e.g., levodopa, dopamine agonists or monoamine oxidase inhibitors) defined as either good or excellent responses (50-100%) for at least one year or moderate responses (30-49)% for at least three years prior to screen.
• Participant-reported or clinician-investigator-determined limitation, based on knowledge of medical history, to one or more 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.
• 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 study.
• Have at minimum a moderate burden of non-motor symptoms associated with Parkinson's disease (i.e., MDS-UPDRS part Ia and part Ib summed total score ≥ 9) at study screen to avoid floor effects for the primary endpoint (MDS-NMS).
• The principal investigator or designee must have confidence in the participant's ability to reliably use the TNM™ device, understand the assessments (provided in English only) and to complete the assessment battery within a given on-state period.
• 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 and/or tablets or computers for access to telemedicine platforms.
• Must be willing to answer questions related to sexual interest, arousal, and performance in an interview with study staff.

You may not qualify if…

• 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 or adjusted score ≤ 20 on the Montreal Cognitive Assessment (MoCA) at the screening visit
• 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.
• Have received MRI guided high intensity focused ultrasound within the past 12 months.
• Experience frequent falls. (defined as 2 or more falls in the past month related to Parkinson's disease). Parkinson's falls are defined as falls associated with bradykinesia, freezing, turning, change in posture and postural dizziness and do not include accidental falls.
• Work night shifts
• Use a hearing aid that is implanted or that cannot be easily removed and replaced.
• Has any significant co-morbidity or illness which in the opinion of the investigator would prevent safe participation in the study, compliance with protocol requirements or which presents with symptoms that are also common in PD.
• Demonstrate suicidality at screening (scores ≥ 4 on the C-SSRS Baseline in section "Suicidal Ideation" (In the past Month)). Participants that respond affirmatively to question 4 or 5 (In the past Month) should receive a referral for mental health counseling according to local site regulations and standards
• Use a hearing aid that is implanted or that cannot be easily removed and replaced
• Have a cochlear implant or myringotomy tubes
• Have chronic that has been ongoing for at least 3 months and causes significant impairment of communication and/or impairment of activities of daily living.
• 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 either clinically meaningful central vestibular dysfunction (lifetime) or have experienced clinically meaningful peripheral vestibular dysfunction within the last 12 months. For this purpose, clinically meaningful is defined as vestibular dysfunction which causes at least a minimal impairment in the individual activities of daily living (e.g., dressing, bathing, preparing food, conducting household chores, work or recreational activities).
• In the Investigator's opinion, currently abuse alcohol, abuse drugs (including legal, illegal or prescribed drugs) or have a history of alcohol or drug dependency within the past 5 years or use any drugs excluded as noted in the Excluded Medications List
• 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, 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.

Where it is running

• Movement Disorder Center of Arizona — Scottsdale, Arizona, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• CenExel Rocky Mountain Clinical Research — Englewood, Colorado, United States
• Parkinson's Disease and Movement Disorders Center of Boca Raton — Boca Raton, Florida, United States
• Headlands Research Orlando — Orlando, Florida, United States
• USF Parkinson's Disease and Movement Disorders Center — Tampa, Florida, United States
• University of Kansas Medical Center - Parkinson's Disease Center — Kansas City, Kansas, United States
• Quest Research — Farmington Hills, Michigan, United States
• Mercy Health Saint Mary's — Grand Rapids, Michigan, United States
• University of New Mexico — Albuquerque, New Mexico, United States
• Mount Sinai Hospital — New York, New York, United States
• Meridian Clinical Research — Raleigh, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Veracity Neuroscience — Memphis, Tennessee, United States
• Texas Movement Disorder Specialist — Georgetown, Texas, United States
• Houston Methodist Neurological Institute — Houston, Texas, United States
• Georgetown University — McLean, Virginia, United States
• Riverside Neurology Specialists — Newport News, Virginia, United States
• Inland Northwest Research — Spokane, Washington, United States
• King's College Hospital NHS Foundation Trust — London, United Kingdom

Full record on ClinicalTrials.gov

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