Affective Posner fMRI frustration induction task for Hyperkinesis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MD
Hyperkinesis+5 More
Affective Posner fMRI frustration induction task - Behavioral
Eligibility
< 18
All Sexes
What conditions do you have?
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Study Summary

Background: Irritability is an elevated proneness to anger. Children with irritability have difficulty tolerating frustration. They get angry and have temper outbursts more easily than their others their age. Irritability is a symptom of DMDD and ADHD. (DMDD is disruptive mood dysregulation disorder. ADHD is attention deficit/hyperactivity disorder.) Yet the reasons why some children get irritated easily are not well understood. Objective: To use brain imaging methods to study responses to frustration in youth. Eligibility: Youth aged 8 to 17 years with severe irritability (including those diagnosed with DMDD) and/or ADHD. Healthy volunteers are also needed. All participants are already enrolled in studies 02-M-0021 or 01-M-0192. Design: Participants will visit the clinic 3 times. The second and third visits will be 3 to 4 weeks apart. The first visit will be an enrollment visit. They will receive training on the tasks they will do during the study. Participants and their parents will take surveys. They will answer questions about their moods and feelings. Participants will train for an MRI scan. They will lie in a mock scanner tube and hear the noises an MRI makes. On the second and third visits, participants will have real MRI scans. They will play a computer game or watch a movie during each scan. The scans will last about 1 hour. The week after each scan, participants will wear a device on their wrist to measure their heart rate and activity level. Participants and their parent will use a smartphone to answer questions about how they are feeling and acting. Participants who do not have smartphones will be given one to use during the study.

Eligible Conditions

  • Hyperkinesis
  • Mood (psychological function)
  • Normal Physiology
  • Attention Deficit Hyperactivity Disorder (ADHD)

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: during first scanning session

Week 5
Variance of information (VIn) measures
during first scanning session
Diffusion tensor imaging (DTI) metrics
for one week after each of the two scanning sessions
ecological momentary assessment (EMA) measures
Week 5
prediction of irritability ratings by global efficiency

Trial Safety

Trial Design

1 Treatment Group

frustration and control fMRI tasks
1 of 1
Experimental Treatment

250 Total Participants · 1 Treatment Group

Primary Treatment: Affective Posner fMRI frustration induction task · No Placebo Group · N/A

frustration and control fMRI tasks
Behavioral
Experimental Group · 1 Intervention: Affective Posner fMRI frustration induction task · Intervention Types: Behavioral

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during first scanning session
Closest Location: National Institutes of Health Clinical Center · Bethesda, MD
Photo of maryland 1Photo of maryland 2Photo of maryland 3
2016First Recorded Clinical Trial
4 TrialsResearching Hyperkinesis
276 CompletedClinical Trials

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,490 Previous Clinical Trials
1,765,821 Total Patients Enrolled
46 Trials studying Hyperkinesis
11,235 Patients Enrolled for Hyperkinesis
Ellen Leibenluft, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
2 Previous Clinical Trials
1,492 Total Patients Enrolled
1 Trials studying Hyperkinesis
189 Patients Enrolled for Hyperkinesis

Eligibility Criteria

Age < 18 · All Participants · 5 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are a healthy adult male or female, aged 18 years or older.
Subjects will be recruited from a cohort of individuals with ADHD and/or DMDD.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.