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Status:

RECRUITING

Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers

Lead Sponsor:

National Institute of Mental Health (NIMH)

Conditions:

Irritability

Eligibility:

All Genders

18-55 years

Phase:

EARLY_PHASE1

Brief Summary

Background: Irritability can be defined as an unusually strong response to frustration; these responses may include severe temper outbursts and a constant grumpy mood. Irritability is a common sympto...

Detailed Description

STUDY DESCRIPTION: Participants in this study will be healthy adults. This protocol uses a frustration induction task, magnetoencephalography (MEG), and brain magnetic resonance imaging (MRI), couple...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA:
  • This study will include adult healthy volunteers.
  • Age: 18-55
  • Consent: can give consent
  • Speak and read English
  • -The instruments have not been validated in other languages.
  • At the NIH site, previously screened through other NIH protocols such as protocol 01-M-0254, 17-M-0181, and 93-M-0170 and determined eligible as healthy volunteers.
  • EXCLUSION CRITERIA:
  • An individual who meets any of the following criteria will be excluded from participation in this
  • study:
  • Any serious medical condition
  • History, physical exam, or laboratory testing including drug abuse screen.
  • Prescription and over-the-counter medications and dietary supplements with psychoactive properties (e.g., St. John's Wort, Melatonin, Valerian)
  • Any condition that interferes with MRI or MEG\*\*
  • History
  • Any current psychiatric diagnosis
  • SCID-V, clinical assessment, or history.
  • Pregnancy
  • Pregnancy testing will be done before all MRIs.
  • People who work on night shifts
  • History
  • Drug use
  • Subjects with drug use or positive drug screen more than two years ago are eligible for participation.
  • Need to wear eye glasses to work with computers\*
  • History
  • Need to wear contact lenses to work with computers\*\*,\*\*\*
  • History
  • Dental retainer\*\*
  • Subjects wearing removable dental retainers are eligible for participation
  • Eye glasses create artifacts in MEG and their rigid shape does not fit well in the MEG scanner. The MEG core has plastic optometry lenses that can be placed in paper frames. However, the paper frames need to be secured with tape which makes wearing them very uncomfortable, potentially promoting negative emotion and reducing the reliability of facial expression analysis.
  • Only applies to the NIH site.
  • Contact lenses create artifacts that interfere with eye-tracking.

Exclusion

    Key Trial Info

    Start Date :

    February 21 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    August 31 2027

    Estimated Enrollment :

    80 Patients enrolled

    Trial Details

    Trial ID

    NCT06484088

    Start Date

    February 21 2025

    End Date

    August 31 2027

    Last Update

    December 2 2025

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    National Institutes of Health Clinical Center

    Bethesda, Maryland, United States, 20892

    2

    Texas A&M University

    College Station, Texas, United States, 77843