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fMRI in Postural Tachycardia Syndrome

Study acronym: POTS
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 1, 2026 → Dec 1, 2027
See other at-risk trials from Milton S. Hershey Medical Center

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion pushed from Dec 1, 2026 to Dec 1, 2027
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Notable Primary and study completion dates: Dec 1, 2025 to Dec 1, 2026v22
  3. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 55 to confirmed 21
    • Site details revised
    v21
  4. Minor Re-verified, no change to tracked fieldsv20
  5. Notable Primary and study completion dates: Dec 1, 2024 to Dec 1, 2025
    • Eligibility criteria expanded, about 65 words
    • Site contact updated
    v19
Show 17 earlier versionsHide 17 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv18
  2. Notable Primary and study completion dates: Feb 1, 2024 to Dec 1, 2024v17
  3. Minor 3 versions Re-verified since Jun 2, 2022, no change to tracked fieldsv14-v16
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Feb 1, 2022 to Feb 18, 2022
    v13
  5. Minor Eligibility criteria expanded, about 11 words
    • Secondary endpoints: 5 to 4
    • Study description expanded, about 1 word
    v12
  6. Notable Start date: Aug 1, 2021 to Feb 1, 2022v11
  7. Minor Re-verified, no change to tracked fieldsv10
  8. Notable Start date: Feb 1, 2021 to Aug 1, 2021v9
  9. Notable Start date: Dec 1, 2020 to Feb 1, 2021
    • Primary and study completion dates: Dec 1, 2023 to Feb 1, 2024
    v8
  10. Notable Primary and study completion dates: Dec 1, 2022 to Dec 1, 2023
    • Start date: Jul 1, 2020 to Dec 1, 2020
    v7
  11. Minor Re-verified, no change to tracked fieldsv6
  12. Notable Start date: Apr 1, 2020 to Jul 1, 2020v5
  13. Notable Start date: Mar 1, 2020 to Apr 1, 2020
    • Interventions: Lower Body Negative Pressure (Device), Sham Pressure (Device) to Lower Body Negative Pressure (Other), Sham Pressure (Other)
    • Eligibility criteria expanded, about 24 words
    • Study description expanded, about 185 words
    v4
  14. Notable Start date: Dec 1, 2019 to Mar 1, 2020v3
  15. Minor Secondary endpoints: details revised at 2 of 5 entriesv2
  1. Minor 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.
Postural tachycardia syndrome (POTS) is one of the most common forms of chronic orthostatic intolerance in the United States. This is a disabling disorder characterized by an excessive increase in heart rate upon standing that is accompanied by symptoms such as dizziness and fatigue. One of the most under appreciated and bothersome symptoms of POTS is impaired cognition or "brain fog," which occurs to a level that interferes with daily activities such as work and education. Despite this high impact, the reasons why POTS patients have problems with cognition are not well understood. This project will test the overall hypothesis that "brain fog" in POTS is related to increased activation of cognitive brain regions during mental tasks when compared with healthy subjects, and that this activation is exacerbated by in the presence of orthostatic stress.
Trial Details
NCT Number NCT04137757
Lead Sponsor Milton S. Hershey Medical Center
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Conditions
(from sponsor)
Postural Tachycardia Syndrome
Related terms Postural Orthostatic Tachycardia Syndrome
Enrollment 21 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov