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Low-intensity Focused Ultrasound and Autonomic Response

StatusEnrolling by Invitation
PhaseNot applicable
Started
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Record History

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  1. Primary completion date: Apr 30, 2026 to Dec 30, 2026
    • Study completion date: Dec 30, 2026 to Dec 30, 2027
    v9
  2. Primary completion date: Apr 30, 2025 to Apr 30, 2026
    • Study completion date: Apr 30, 2025 to Dec 30, 2026
    v8
  3. Trial status: Not Yet Recruiting to Enrolling by Invitationv7 Show 6 more changesShow less
    • Start date changed from estimate of Jun 1, 2024 to Feb 22, 2024
    • Interventions: Low-intensity focused ultrasound neuromodulation (Device) to Low-intensity focused ultrasound neuromodulation (Device), Sham Low-intensity focused ultrasound (Device)
    • Eligibility criteria expanded, about 27 words
    • Study description shortened, about 17 words
    • Site contact updated
    • Study arms: 1 to 3
  4. Start date: Feb 1, 2024 to Jun 1, 2024v6
  5. Start date: Jan 1, 2024 to Feb 1, 2024v5
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Oct 1, 2023 to Jan 1, 2024v4
  2. Start date: Jul 1, 2023 to Oct 1, 2023v3
  3. Start date: Apr 30, 2023 to Jul 1, 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Studying the effects of Low Intensity Focused Ultrasound (LIFU) to the dorsal posterior insula (dPI) and dorsal anterior cingulate cortex (dACC) on autonomic control using a test to probe the autonomic system. A cold pressor task will be performed pre and post LIFU application. Physiologic recordings will be recorded throughout.
Trial Details
NCT Number NCT05834829
Lead Sponsor Virginia Polytechnic Institute and State University
Conditions
(from sponsor)		 Autonomic Dysfunction
Related terms Primary Dysautonomias
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov