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

This study has been terminated.
(Due to slow enrollment and lack of funding the study was terminated prior to completion.)
Sponsor:
Collaborator:
ElMindA Ltd
Information provided by (Responsible Party):
Gagan Joshi, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01506232
First received: January 5, 2012
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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
Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorder
Bipolar Disorder

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Agreement between clinical diagnoses and the results of brain activity flow pattern analysis (BAFPA). [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 1
Study Start Date: March 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506232

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

No publications provided

Responsible Party: Gagan Joshi, MD, Scientific Director, Pervasive Developmental Disorders Program, Clinical and Research Programs in Pediatric Psychopharmacology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01506232     History of Changes
Other Study ID Numbers: 2010P000547
Study First Received: January 5, 2012
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
ADHD
Pediatric Bipolar Disorder
Autism
Autism Spectrum Disorders
EEG
Brain Flow Analyses

Additional relevant MeSH terms:
Autistic Disorder
Bipolar Disorder
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Affective Disorders, Psychotic
Mood Disorders
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 19, 2014