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STEM-PD Open Label Extension (OLE) | Clinical Trials | Clareo Health

TERMINATEDNA

STEM-PD Open Label Extension (OLE)

Non-Invasive Brainstem Modulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease: An Open Label Extension (OLE) Study

NCT04799418•Scion NeuroStim

View on ClinicalTrials.gov

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.

Detailed Description

Up to 220 participants will enter an open label extension study during which all study participants will receive active (i.e., time-varying caloric vestibular stimulation) treatment for 12 weeks (84 days). Study participants will be followed for 16 weeks (112 days) post treatment-cessation and then the twice daily active treatments will be re-introduced for the final 8 weeks (56 days).

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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).

Exclusion Criteria

•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:
•Inclusion:
•1. Adult participants (aged 18 - 85 years inclusive).
•2. Have been diagnosed with PD according to the UK Brain Bank Criteria (allowing for an exclusion in Step 2 for "more than one affected relative").
•3. 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.
•4. 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.).
•5. Participants must be able and willing to consent to participate in the study for the RCT and OLE.
•6. Participants must be willing and able to comply with study requirements.
+31 more criteria

Locations (15)

Movement Disorder Center of Arizona

Scottsdale, Arizona, United States

Cedars-Sinai Medical Center

Los Angeles, California, United States

Parkinson's Disease and Movement Disorder of Boca Raton

Boca Raton, Florida, United States

Headlands Research Orlando

Orlando, Florida, United States

University of South Florida

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

Meridian Clinical Research

Raleigh, North Carolina, United States

Key Dates

Start Date

September 15, 2022

Primary Completion Date

February 24, 2025

Completion Date

February 24, 2025

Last Updated

July 3, 2025

Enrollment

148

ACTUAL participants

Conditions

Parkinson DiseaseParkinson's Disease and Parkinsonism

Interventions

Open Label Extension Study

DEVICE

[18F]F-DOPA Imaging in Patients With Autonomic Failure

NCT04246437

Autonomic FailurePure Autonomic Failure+3 more

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RECRUITINGNA

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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STEM-PD Open Label Extension (OLE)

Inclusion Criteria

Exclusion Criteria

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations