STEM-Parkinson's Disease

NCT04797611 | Completed Results DMC FDA Device

• 1 other identifier: SNS-PD-002
• Study Type: interventional
• Target: 188
• Locations: 2 countries
• Sites: 23

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.

Conditions

Parkinson Disease; Parkinson's Disease and Parkinsonism

Keywords

Randomized Controlled Trial (RCT); Medical Devices; Non-Motor Symptoms (NMS); Non-Invasive Brain Stimulation; tvCVS

Outcome Measures

Primary Outcomes (1)

• Change in The International Parkinson and Movement Disorder Society Non-Motor Rating Scale (MDS-NMS) Total Score

  The MDS-NMS is a 52-item rater-administered scale used to assess a wide range of non-motor symptoms in Parkinson's disease. It measures both frequency (0/never to 4/ \>51% of the time) and severity (0/not present to 4/major distress or disturbance) of 13 domains (depression, anxiety, apathy, psychosis, impulse control/related disorders, cognition, orthostatic hypotension, urinary, sexual, gastrointestinal, sleep/wakefulness, pain, and other). Each question is scored by multiplying frequency x severity. All question scores for each domain are summed, and the scores for each domain are summed to provide the Total Score (range = 0-832) with the higher score indicating greater non-motor symptom burden. The higher the total score, the more progressed (i.e., worse) is the disease state. The change/difference in scores between the baseline (average of Days 1 and 29) and end of study treatment (Day 113) are reported. A positive change in scores indicates worsening.

  3 months

Secondary Outcomes (5)

• Change in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS): Parts I, II, and III Combined Score

  3 months

• Change in The International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II

  3 months

• Change From Baseline in the Clinical Global Impression-Improvement (CGI-I)

  3 months

• Change in the International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale MDS-UPDRS Part III

  3 months

• Change From in the Parkinson's Disease Quality of Life Questionnaire Summary Index (PDQ-39 SI)

  3 months

Other Outcomes (19)

• Change in the Mini-Balance Evaluation Systems Test (Mini BESTest)

  3 months

• Change in the Montreal Cognitive Assessment (MoCA)

  3 months

• Change in the Oral Symbol Digit Modality Test (Oral SDMT)

  3 months

Study Arms (2)

Active: Investigational Treatment 1

ACTIVE COMPARATOR

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

Device: TNM Device

Passive: Investigational Treatment 2

SHAM COMPARATOR

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

Device: TNM Device

Interventions

TNM Device 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.

Also known as: tvCVS

Active: Investigational Treatment 1; Passive: Investigational Treatment 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult participants (aged 18 - 85 years inclusive)
• 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

Sponsors & Collaborators

• Scion NeuroStim: lead

Study Sites (23)

Movement Disorder Center of Arizona

Scottsdale, Arizona, 85258, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

CenExel Rocky Mountain Clinical Research

Englewood, Colorado, 80113, United States

Location

Parkinson's Disease and Movement Disorders Center of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Headlands Research Orlando

Orlando, Florida, 32819, United States

Location

USF Parkinson's Disease and Movement Disorders Center

Tampa, Florida, 33613, United States

Location

University of Kansas Medical Center - Parkinson's Disease Center

Kansas City, Kansas, 66160, United States

Location

Quest Research

Farmington Hills, Michigan, 48334, United States

Location

Mercy Health Saint Mary's

Grand Rapids, Michigan, 49503, United States

Location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Meridian Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19107, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Veracity Neuroscience

Memphis, Tennessee, 38157, United States

Location

Texas Movement Disorder Specialist

Georgetown, Texas, 78628, United States

Location

Houston Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

Georgetown University

McLean, Virginia, 22101, United States

Location

Riverside Neurology Specialists

Newport News, Virginia, 23601, United States

Location

Inland Northwest Research

Spokane, Washington, 99202, United States

Location

King's College Hospital NHS Foundation Trust

London, SW9 8RR, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Limitations and Caveats

None to report

Results Point of Contact

• Title: Robert Black
• Organization: Scion NeuroStim, Inc

bacllc@earthlink.net

919-260-5528

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: May 19, 2022
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-05

Locations

US (22); GB (1)