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 range6 Years – 17 Years

SexALL

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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…

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