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

NCT01506232 | Terminated

• 1 other identifier: 2010P000547
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder; Autism Spectrum Disorder; Bipolar Disorder

Keywords

ADHD; Pediatric Bipolar Disorder; Autism; Autism Spectrum Disorders; EEG; Brain Flow Analyses

Outcome Measures

Primary Outcomes (1)

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

  Subjects will undergo clinical diagnostic interviews and a comprehensive neuropsychological assessment, and then complete 1 EEG scan of approximately 1 hour. The results of the BAFPA will be compared to the results of the clinical diagnostic interviews.

  Baseline

Study Arms (4)

ADHD

Youth diagnosed with ADHD.

ASD

Youth diagnosed with an Autism Spectrum Disorder (ASD).

BPD

Youth diagnosed with Bipolar Disorder.

Healthy Controls

Youth not diagnosed with any psychiatric/psychological disorder.

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Youths ages 6-17 diagnosed with ADHD, ASD or BPD, or heathy controls.

You may qualify if:

• 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.

You may not qualify if:

• 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 psychiatric conditions or judged to be at serious suicidal risk
• Current diagnosis of schizophrenia
• History of substance use (except nicotine or caffeine) within past 3 months or urine drug screen positive for substances of abuse
• Significant sensory deficits such as deafness or blindness.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• ElMindA Ltd: collaborator

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Autism Spectrum Disorder; Bipolar Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Child Development Disorders, Pervasive; Bipolar and Related Disorders; Mood Disorders

Study Officials

• Gagan Joshi, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director, Pervasive Developmental Disorders Program, Clinical and Research Programs in Pediatric Psychopharmacology

Study Record Dates

• First Submitted: January 5, 2012
• First Posted: January 9, 2012
• Study Start: March 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 28, 2024

Record last verified: 2024-06

Locations

US (1)