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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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
2
Texas A&M University
College Station, Texas, United States, 77843