TerminatedNot Applicable

Brain Activity Flow Patterns Analysis Using Evoked Response Potentials in Youth With ADHD, Bipolar Disorder, or Autism Spectrum Disorders: A Preliminary Study

Stopped: Due to slow enrollment and lack of funding the study was terminated prior to completion.

United States1 participantsStarted 2011-03

Plain-language summary

The study aims to evaluate whether or not an EEG (a type of brain scan) is useful in diagnosing youth with either ADHD, BPD, ASD. Youth with ADHD, BPD, ASD, and healthy controls (without ADHD, BPD, and ASD) will undergo an EEG, and the results will be analyzed using brain activity flow pattern analysis (BAFPA). Twenty subjects with each disorder and twenty without any of the disorders under study (controls) will be evaluated. All subjects will be comprehensively assessed with structured diagnostic interviews and neuropsychological testing. All EEG analyses will be conducted under blind conditions. Conditional probability and receiver operating characteristic (ROC) analyses will examine the diagnostic utility of the EEG scan, using the clinical diagnosis of ASD as the gold standard.

Who can participate

Age range

6 Years – 17 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male or female participants between 6 and 17 years of age. * Right handedness. * Fulfills DSM-IV-TR diagnostic criteria for ADHD, bipolar disorder (BPD I, II, or NOS), or ASD (autistic disorder, Asperger's disorder, or PDD-NOS) as established by clinical diagnostic interview and supported by K-SADS-E module for respective diagnoses. * Subjects and their legal representative must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with all tests and examinations required by the protocol. * Subjects and their legal representative must be considered reliable. * Each subject and his/her authorized legal representative must understand the nature of the study. The subject's authorized legal representative must sign an informed consent document and the subject must sign an informed assent document. Exclusion Criteria: * Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild. * I.Q. \< 85 * History of active seizure disorder (as suggested by EEG suggestive of seizure activity and/or history of seizure in last 1 month) * Pregnant or nursing females. * Subjects with a medical condition that will either jeopardize subject safety or affect the scientific merit of the study, including: * Organic brain disorders * Uncorrected hypothyroidism or hyperthyroidism * Renal or hepatic impairment. * Clinically unstable psychiat…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Agreement between clinical diagnoses and the results of brain activity flow pattern analysis (BAFPA).

Timeframe: Baseline

Trial details

NCT IDNCT01506232

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-11

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder trials