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STEM-PD Open Label Extension (OLE)

NCT04799418 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2025-07-03

Study results available
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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

Interventions

DEVICE

Open Label Extension Study

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

Sponsors & Collaborators

  • Scion NeuroStim

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2025-02-24
Completion
2025-02-24
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04799418 on ClinicalTrials.gov