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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01506232
Recruitment Status : Terminated (Due to slow enrollment and lack of funding the study was terminated prior to completion.)
First Posted : January 9, 2012
Last Update Posted : October 25, 2013
ElMindA Ltd
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital

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.

Condition or disease
Attention Deficit Hyperactivity Disorder Autism Spectrum Disorder Bipolar Disorder

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Brain Activity Flow Patterns Analysis Using Evoked Response Potentials in Youth With ADHD, Bipolar Disorder, or Autism Spectrum Disorders: A Preliminary Study
Study Start Date : March 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

Youth diagnosed with ADHD.
Youth diagnosed with an Autism Spectrum Disorder (ASD).
Youth diagnosed with Bipolar Disorder.
Healthy Controls
Youth not diagnosed with any psychiatric/psychological disorder.

Primary Outcome Measures :
  1. Agreement between clinical diagnoses and the results of brain activity flow pattern analysis (BAFPA). [ Time Frame: Baseline ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Youths ages 6-17 diagnosed with ADHD, ASD or BPD, or heathy controls.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01506232

United States, Massachusetts
Massachusetts General Hospital
Cambridge, Massachusetts, United States, 02138
Sponsors and Collaborators
Massachusetts General Hospital
ElMindA Ltd
Principal Investigator: Gagan Joshi, MD Massachusetts General Hospital

Responsible Party: Gagan Joshi, MD, Scientific Director, Pervasive Developmental Disorders Program, Clinical and Research Programs in Pediatric Psychopharmacology, Massachusetts General Hospital Identifier: NCT01506232     History of Changes
Other Study ID Numbers: 2010P000547
First Posted: January 9, 2012    Key Record Dates
Last Update Posted: October 25, 2013
Last Verified: October 2013

Keywords provided by Gagan Joshi, MD, Massachusetts General Hospital:
Pediatric Bipolar Disorder
Autism Spectrum Disorders
Brain Flow Analyses

Additional relevant MeSH terms:
Autistic Disorder
Bipolar Disorder
Attention Deficit Disorder with Hyperactivity
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Bipolar and Related Disorders
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes