STEM-Parkinson's Disease

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Scion NeuroStim
Study ID
NCT04797611
Status
Completed

Conditions

Eligibility Criteria

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

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.

Study Details

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.

Key Dates

Start date
May 19, 2022
Status verified
May 2025
Primary completion
Dec 6, 2024
Completion
Dec 6, 2024

Study Design

Enrollment
188 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active: Investigational Treatment 1
    Investigational treatment mode (stimulation pattern) 1 - twice daily, 19 minute, active waveform treatments
  • Sham Comparator: Passive: Investigational Treatment 2
    Investigational treatment mode (stimulation pattern) 2 - twice daily, 19 minute, passive waveform treatments

Primary Outcome Measure

Change in The International Parkinson and Movement Disorder Society Non-Motor Rating Scale (MDS-NMS) Total Score [ Time Frame: 3 months ]

Locations (22)

FacilityCityStateZIPSite coordinators
Movement Disorder Center of ArizonaScottsdaleArizona85258-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
CenExel Rocky Mountain Clinical ResearchEnglewoodColorado80113-
Parkinson's Disease and Movement Disorders Center of Boca RatonBoca RatonFlorida33486-
Headlands Research OrlandoOrlandoFlorida32819-
USF Parkinson's Disease and Movement Disorders CenterTampaFlorida33613-
University of Kansas Medical Center - Parkinson's Disease CenterKansas CityKansas66160-
Quest ResearchFarmington HillsMichigan48334-
Mercy Health Saint Mary'sGrand RapidsMichigan49503-
University of New MexicoAlbuquerqueNew Mexico87131-
Mount Sinai HospitalNew YorkNew York10029-
Meridian Clinical ResearchRaleighNorth Carolina27607-
Cleveland ClinicClevelandOhio44195-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19107-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Veracity NeuroscienceMemphisTennessee38157-
Texas Movement Disorder SpecialistGeorgetownTexas78628-
Houston Methodist Neurological InstituteHoustonTexas77030-
Georgetown UniversityMcLeanVirginia22101-
Riverside Neurology SpecialistsNewport NewsVirginia23601-
Inland Northwest ResearchSpokaneWashington99202-

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, CACenExel Rocky Mountain Clinical Research· Englewood, COParkinson's Disease and Movement Disorders Center of Boca Raton· Boca Raton, FLHeadlands Research Orlando· Orlando, FLUSF Parkinson's Disease and Movement Disorders Center· Tampa, FL

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