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

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.

Study Overview

• Status: Terminated
• Conditions: Bipolar Disorder; Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Cambridge, Massachusetts, United States, 02138
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: ElMindA Ltd
• Investigators: Principal Investigator: Gagan Joshi, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 5, 2012
• First Submitted That Met QC Criteria: January 5, 2012
• First Posted (Estimated): January 9, 2012

Study Record Updates

• Last Update Posted (Actual): June 28, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: ADHD; Autism; EEG; Pediatric Bipolar Disorder; Autism Spectrum Disorders; Brain Flow Analyses
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Bipolar Disorder; Attention Deficit Disorder with Hyperactivity; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
• Other Study ID Numbers: 2010P000547