STEM-PD Open Label Extension (OLE)

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Scion NeuroStim
Study ID
NCT04799418
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

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.

Study Details

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 Dates

Start date
Sep 15, 2022
Status verified
Jul 2025
Primary completion
Feb 24, 2025
Completion
Feb 24, 2025

Study Design

Enrollment
148 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: passive-active
    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.
  • Experimental: active-active
    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.

Primary Outcome Measure

Change From Baseline in The International Parkinson and Movement Disorder Society - Non-Motor Rating Scale (MDS-NMS) Total Score [ Time Frame: 3 months (NCT04797611 RCT: Day 29 - Day 113; This OLE: Day 113 to Day 197) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Movement Disorder Center of ArizonaScottsdaleArizona85258-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Parkinson's Disease and Movement Disorder of Boca RatonBoca RatonFlorida33486-
Headlands Research OrlandoOrlandoFlorida32819-
University of South FloridaTampaFlorida33613-
University of Kansas Medical Center - Parkinson's Disease CenterKansas CityKansas66160-
Quest ResearchFarmington HillsMichigan48334-
Mercy Health Saint Mary'sGrand RapidsMichigan49503-
University of New MexicoAlbuquerqueNew Mexico87131-
Meridian Clinical ResearchRaleighNorth Carolina27607-
Cleveland ClinicClevelandOhio44195-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Veracity NeuroscienceMemphisTennessee38157-
Houston Methodist Neurological InstituteHoustonTexas77030-
Riverside Neurology SpecialistsNewport NewsVirginia23601-

Find similar trials in Scottsdale, AZ

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Movement Disorder Center of Arizona· Scottsdale, AZCedars-Sinai Medical Center· Los Angeles, CAParkinson's Disease and Movement Disorder of Boca Raton· Boca Raton, FLHeadlands Research Orlando· Orlando, FLUniversity of South Florida· Tampa, FLUniversity of Kansas Medical Center - Parkinson's Disease Center· Kansas City, KS

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