Recruiting

Early Phase 1

Observational StudyStudy Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers

Sponsor:

National Institute of Mental Health (NIMH)

Code:

NCT06484088

Conditions

Irritability

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Frustration task

Study Details

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 symptom of many mental health disorders. Little is known about how the brain responds to frustration, and few treatments are available for this problem. Researchers want to know more about how the brain responds to frustration.

Objective:

To learn how the brain responds to frustration.

Eligibility:

Healthy adults aged 18 to 55 years. They must have been screened through studies 01-M-0254 or 17-M-0181.

Design:

Participants will have up to 3 study visits in 2 months. Each visit will last up to 4 hours.

Visit 1: Participants will be screened. They will have a physical exam. They will complete questionnaires about how often and how easily they get angry or grumpy. They will be trained to use a device that measures hand grip.

Visit 2: Participants will have a magnetic resonance imaging (MRI) scan. They will lie on a table that slides into a tube. Padding will hold their head still.

Visit 3: Participants will undergo magnetoencephalography (MEG). A cone with detectors will be lowered over their head while they are seated. The MEG will measure the magnetic fields in the participant s brain both while they are resting and while they are doing the frustration task. For the task, they will hold a grip device in each hand. They will use the devices to pick 1 of 2 doors on a computer screen. The task has 3 parts. The participant s face will be filmed during this task.

Conditions

Irritability

Study ID

NCT06484088

Start date

Feb 21, 2025

Status verified date

Sep 2, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

-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.

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Frustration task

The experimental manipulation for this study is the frustration task. The frustration task is designed to elicit the emotional state of frustrative non-reward (FNR). During the task, participants are asked to use button press (left or right) to alternately press one of the two doors displayed on the monitor. The task has two non-frustration blocks (Block 1 and 2) and one frustration block (Block 3). During the non-frustration blocks, participants earn money for correct press on a fixed schedule. During the frustrative block, participants will not always receive reward for correct press.

Interventions

Frustration task

Primary outcome measure

(1) The power of neural oscillations in the cortical-basal ganglia-thalamic circuit; (2) Coherence of neural oscillations in this circuit; (3) Frustration rating by self-report, facial expression, and the duration and strength of gripping. [ Time Frame: The measurements will be taken during the MEG/frustration task session. ]

Central Contacts and Locations

Central contacts

Zheng Li, Ph.D.

(301) 594-2269 lizheng2@mail.nih.gov

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Office of Patient Recruitment (OPR)

800-411-1222 ccopr@nih.gov

Zheng Li, Ph.D.

(301) 594-2269 lizheng2@mail.nih.gov

More Information

Sponsor

National Institute of Mental Health (NIMH)

Last update posted

Sep 4, 2026

Last verified

Sep 2, 2026

Keywords

Healthy volunteers, Frustration, Magnetoencephalography

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Institute of Mental Health (NIMH) on 2026-09-04.