NCT06484088 Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
| NCT ID | NCT06484088 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | National Institute of Mental Health (NIMH) |
| Condition | Irritability |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2025-02-21 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 90 participants in total. It began in 2025-02-21 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
-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.
Contact & Investigator
Zheng Li, Ph.D.
PRINCIPAL INVESTIGATOR
National Institute of Mental Health (NIMH)
Frequently Asked Questions
Who can join the NCT06484088 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Irritability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06484088 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06484088 currently recruiting?
Yes, NCT06484088 is actively recruiting participants. Contact the research team at lizheng2@mail.nih.gov for enrollment information.
Where is the NCT06484088 trial being conducted?
This trial is being conducted at Bethesda, United States, College Station, United States.
Who is sponsoring the NCT06484088 clinical trial?
NCT06484088 is sponsored by National Institute of Mental Health (NIMH). The principal investigator is Zheng Li, Ph.D. at National Institute of Mental Health (NIMH). The trial plans to enroll 90 participants.