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NCT06484088 · ClinicalTrials.gov registry record · Early Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
A Early Phase 1 study of Irritability, sponsored by National Institute of Mental Health (NIMH).
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT06484088: Recruiting Early Phase 1 study of Irritability, sponsored by National Institute of Mental Health (NIMH).
NCT06484088 is a Early Phase 1 study of Irritability that is actively recruiting participants, run by National Institute of Mental Health (NIMH). The registered enrollment target is 80 participants, below the 134-participant average among 3 other Irritability trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06484088, a Early Phase 1 study of Irritability, is actively recruiting participants, sponsored by National Institute of Mental Health (NIMH).
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Frustration task
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Texas
- Texas A&M University - College Station
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-02-21 |
| Est. Completion | 2027-08-31 |
| Phase | Early Phase 1 |
What NCT06484088 shows while recruiting
NCT06484088 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 134-participant average among 3 other Irritability trials with a reported enrollment target (40% lower).
The record links to 1 condition, with Irritability appearing as the primary indexed condition, and to 1 intervention - of which Frustration task is the first listed.
NCT06484088 reports a single indexed study location in Maryland, Texas.
Frequently Asked Questions
What is clinical trial NCT06484088 about?
NCT06484088 is a clinical study titled "Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers". 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 ...
What is the current status of trial NCT06484088?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 80 participants. The study started on 2025-02-21. Estimated completion is 2027-08-31.
What conditions does trial NCT06484088 study?
This clinical trial studies the following conditions: Irritability.
What interventions are being tested in trial NCT06484088?
The interventions under investigation include: Frustration task (OTHER).
Who is sponsoring clinical trial NCT06484088?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06484088 being conducted?
This trial has 2 study locations across Maryland, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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