Clinical trial NCT01506232: Brain Activity Flow Patterns Analysis Using Evoked Response Potentials in Youth With ADHD, Bipolar Disorder, or Autism Spectrum Disorders: A Preliminary Study
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Attention Deficit Hyperactivity Disorder
Autism Spectrum Disorder
Bipolar Disorder
Keywords: ADHD
Pediatric Bipolar Disorder
Autism
Autism Spectrum Disorders
EEG
Brain Flow Analyses
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: ElMindA Ltd
First posted: 2012-01-09
Enrollment: 1
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youths ages 6-17 diagnosed with ADHD, ASD or BPD, or heathy controls.

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.


Eligibility 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.

Primary outcomes:
measure: Agreement between clinical diagnoses and the results of brain activity flow pattern analysis (BAFPA).
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Gagan Joshi, MD
role: PRINCIPAL_INVESTIGATOR
References: