STEM-Parkinson's Disease

NCT ID: NCT04797611

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 188 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-19
• Study Completion Date: 2024-12-06

Brief Summary

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.

Detailed Description

The double-blinded, controlled, randomized clinical trial (RCT) will be conducted at 15 centers, at minimum, in the United States and the United Kingdom with the majority of centers in the United States. Up to 184 participants will enter and will self-administer treatments twice daily in their home setting over a period of 12 weeks following a 4 week baseline period. Each participant will complete 6 study visits: 3 visits at the study center and 3 visits completed in the participant's home by video call.

Conditions

Parkinson Disease; Parkinson's Disease and Parkinsonism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active: Investigational Treatment 1

Investigational treatment mode (stimulation pattern) 1 - twice daily, 19 minute, active waveform treatments

Group Type: ACTIVE_COMPARATOR

TNM Device

Intervention Type: DEVICE

Study participants will self-administer \~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive tvCVS 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.

Passive: Investigational Treatment 2

Investigational treatment mode (stimulation pattern) 2 - twice daily, 19 minute, passive waveform treatments

Group Type: SHAM_COMPARATOR

TNM Device

Intervention Type: DEVICE

Study participants will self-administer \~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive tvCVS 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.

Interventions

TNM Device

Study participants will self-administer \~19-minute treatments twice daily in the home setting over 12 weeks using a non-invasive tvCVS 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.

Intervention Type: DEVICE

Other Intervention Names

tvCVS

Eligibility Criteria

Inclusion Criteria

• 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.

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 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.
• 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.
• Have had eye surgery within the previous three months or ear surgery within the previous six months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Scion NeuroStim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SNS-PD-002

Identifier Type: -

Identifier Source: org_study_id