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

NCT ID: NCT01506232

Last Updated: 2024-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder Autism Spectrum Disorder Bipolar Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ADHD

Youth diagnosed with ADHD.

No interventions assigned to this group

ASD

Youth diagnosed with an Autism Spectrum Disorder (ASD).

No interventions assigned to this group

BPD

Youth diagnosed with Bipolar Disorder.

No interventions assigned to this group

Healthy Controls

Youth not diagnosed with any psychiatric/psychological disorder.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ElMindA Ltd

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gagan Joshi

Scientific Director, Pervasive Developmental Disorders Program, Clinical and Research Programs in Pediatric Psychopharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gagan Joshi, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Cambridge, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2010P000547

Identifier Type: -

Identifier Source: org_study_id

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