STEM-PD Open Label Extension (OLE)

NCT04799418 | Terminated Results FDA Device

• 1 other identifier: SNS-PD-003
• Study Type: interventional
• Target: 148
• Locations: 1 country
• Sites: 15

Brief Summary

This study seeks to establish the safety and efficacy of extended twice daily time-varying caloric vestibular stimulation treatments for treating symptoms associated with Parkinson's disease. Only participants who completed the STEM-PD randomized controlled trial portion (NCT04797611) are eligible to participate in the open label extension portion.

Conditions

Parkinson Disease; Parkinson's Disease and Parkinsonism

Keywords

Open Label Extension Study; Medical Devices; Non-Motor Symptoms (NMS); Non-Invasive Brain Stimulation; Parkinson Disease

Outcome Measures

Primary Outcomes (1)

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

  The primary endpoint is the change in MDS-NMS total score during the first treatment period during the open label extension (OLE) relative to the score at the end of the NCT04797611 randomized controlled trial (RCT) treatment period (day 113) for the passive-active treatment group compared to the change in MDS-NMS total score during the RCT treatment period relative to the pretreatment baseline. The MDS-NMS is 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. 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.

  3 months (NCT04797611 RCT: Day 29 - Day 113; This OLE: Day 113 to Day 197)

Secondary Outcomes (5)

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

  3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197)

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

  RCT: from Baseline (Day 29) up to 3 months (Day 113); OLE: from Baseline (Day 29) up to 11 months (Day 365)

• Change From Baseline in the International Parkinson and Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination (MDS-UPDRS Part III)

  3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197)

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

  3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197

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

  3 months (NCT04797611 RCT: Day 29 - Day 113; this OLE: Day 113 to Day 197

Other Outcomes (19)

• Change From Baseline in the Mini-Balance Evaluation Systems Test

  8 months

• Change From Baseline in the Montreal Cognitive Assessment

  8 months

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

  8 months

Study Arms (2)

passive-active

EXPERIMENTAL

This group received passive treatment with the study device in a randomized controlled trial (RCT) that immediately preceded this open label extension (OLE ) trial during which participants received active (i.e., time-varying caloric vestibular stimulation ) treatment.

Device: Open Label Extension Study

active-active

EXPERIMENTAL

This group received active (i.e., time-varying caloric vestibular stimulation) treatment with the study device in a randomized controlled trial (RCT) that immediately preceded this open label extension (OLE) trial during which participants received active treatment. Data from participants in this arm was only used for exploratory outcomes.

Device: Open Label Extension Study

Interventions

Open Label Extension Study DEVICE

This study will investigate the safety and efficacy of extended treatments for the management of symptoms related to PD.

active-active; passive-active

Eligibility Criteria

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

You may qualify if:

• Completion of the study activities in the STEM-PD RCT trial (see STEM-PD RCT eligibility criteria noted below).
• Participants must be willing and able to give consent to participate in the study trial.
• 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 first three months of the OLE (Day197).

You may not qualify if:

• Participant anticipates being unable to attend all visits and complete all study activities.
• Has a planned surgery scheduled to occur during the first 90 days of the OLE that would typically be followed with a prescription for pain management
• STEM-PD RCT Eligibility criteria:
• Adult participants (aged 18 - 85 years inclusive).
• Participants must have demonstrated a sustained positive response to 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 reports limitation 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.).
• Participants must be able and willing to consent to participate in the study for the RCT and OLE.
• Participants must be willing and able to comply with study requirements.
• Participants must have at minimum a moderate burden of NMS (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.
• Must have a study partner (defined as someone who sees the participant for more than one hour a day, 3x per week) that is willing to consent and participate in the trial.
• Participants must have capabilities to use and access smartphones 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.
• Women of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
• Women of child-bearing potential (i.e., are not yet either 3 years removed from their first menopausal symptom or 12 months removed from last menses), who are not abstinent or exclusively in same sex relationships must:

Sponsors & Collaborators

• Scion NeuroStim: lead

Study Sites (15)

Movement Disorder Center of Arizona

Scottsdale, Arizona, 85258, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Parkinson's Disease and Movement Disorder of Boca Raton

Boca Raton, Florida, 33486, United States

Location

Headlands Research Orlando

Orlando, Florida, 32819, United States

Location

University of South Florida

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

Meridian Clinical Research

Raleigh, North Carolina, 27607, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Veracity Neuroscience

Memphis, Tennessee, 38157, United States

Location

Houston Methodist Neurological Institute

Houston, Texas, 77030, United States

Location

Riverside Neurology Specialists

Newport News, Virginia, 23601, United States

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

This study was terminated early due to lack of device effectiveness demonstrated in STEM-PD RCT (NCT04797611) prior to final outcome measures being collected for all participants enrolled in this OLE.

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: NON RANDOMIZED
• Masking: NONE
• Masking Details: Participant, care provider, investigator and outcomes assessors were all blinded to treatment allocation during the randomized controlled trial at the time of data collection in this open label extension
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All participants in this open label extension portion of the study receive active time-varying caloric vestibular stimulation treatment, however, participants were previously randomized to receive the active treatment or passive treatment in a previous randomized controlled trial.

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 16, 2021
• Study Start: September 15, 2022
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: July 3, 2025
• Results First Posted: July 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (15)