Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers

NCT06484088 | Recruiting Early Phase 1

• 2 other identifiers: 10002073002073-M
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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

Keywords

Healthy volunteers, Frustration, Magnetoencephalography

Outcome Measures

Primary Outcomes (1)

• (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.

  MEG recording is acquired during the frustration task. 3-6 minutes of resting-state recording is acquired before, between, and after each block of the frustration task. Feelings of frustration and unhappiness were assessed after each run using 9-point Likert scales. Frustration assessment takes place before and after the task and between each block within the task. The strength and duration of gripping the press device during the task is recorded for all trials.

  The measurements will be taken during the MEG/frustration task session.

Study Arms (1)

Frustration task

EXPERIMENTAL

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.

Other: Frustration task

Interventions

Frustration task OTHER

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.

Frustration task

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): lead

Study Sites (2)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Texas A&M University

College Station, Texas, 77843, United States

NOT YET RECRUITING

Related Publications (38)

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Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• Zheng Li, Ph.D.

  National Institute of Mental Health (NIMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Li, Ph.D.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2024
• First Posted: July 3, 2024
• Study Start: February 21, 2025
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04-16

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: IPD that under results in a publication may be requested by other researchers when the publication is online or in print or by the end of the project/protocol, whichever comes first.
• Access Criteria: IPD that under results in a publication will be made public through NIH-supported scientific data repositories. Access criteria are defined by the repositories and not limited by analysis type.

Locations

US (2)