STEM-PD Open Label Extension (OLE)

Stopped early · Not applicable

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

In brief

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.

Key facts

Study ID

NCT04799418

Run by

Scion NeuroStim

People needed

148

Starts

2022-09-15

Expected to finish

2025-02-24

Last updated by the study team

2025-07-03

Who can join

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

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:
• Inclusion:
• Adult participants (aged 18 - 85 years inclusive).
• 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").
• 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.
• Exclusion:
• 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:
• test negative for pregnancy as indicated by a negative urine pregnancy test;
• agree to use an approved contraception method listed in section 5.3.3 for the entirety of the RCT and OLE;
• Have a history or prior diagnosis of dementia 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 (TIA) within 6 months.
• Are receiving deep brain stimulation therapy.
• Are treated with a pump for continuous delivery of dopamine replacement therapy.
• Have received MRI guided high intensity focused ultrasound within the past 12 months.

Where it is running

• 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
• Cleveland Clinic — Cleveland, Ohio, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Veracity Neuroscience — Memphis, Tennessee, United States
• Houston Methodist Neurological Institute — Houston, Texas, United States
• Riverside Neurology Specialists — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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