NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study (NEBA)

This study has been completed.
Sponsor:
Information provided by:
Lexicor Medical Technology, LLC
ClinicalTrials.gov Identifier:
NCT00595751
First received: January 7, 2008
Last updated: July 29, 2008
Last verified: July 2008
  Purpose

The study will evaluate the effectiveness of a standardized EEG method with the intended clinical users in the intended clinical settings with the intended population (patients who would typically receive a clinician's evaluation for ADHD). Multiple sites will be examined to provide a sample of patients across numerous communities with different demographics. The goal is to evaluate if the predictive accuracy of EEG will not be inferior to that of a widely-used and extensively validated ADHD scale in the prediction of ADHD in the intended use population as evaluated by Best Estimate Diagnosis.


Condition
Attention Deficit Disorder With Hyperactivity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Best Estimate Diagnosis Used to Evaluate EEG in Association With ADHD in a Multi-Site, Clinical Sample of Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Lexicor Medical Technology, LLC:

Primary Outcome Measures:
  • 'Best Estimate Diagnosis' of ADHD applied in the intended population in settings with the intended users [ Time Frame: At prensentation to clinic with attention or behavior problems ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: December 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study focuses on individuals who have consecutively presented to participating clinics with suspected attention and/or behavior concerns and would receive a clinician's comprehensive evaluation for ADHD. The study population includes male and female participants aged 6-17.99 years regardless of race, ethnicity, and socioeconomic origin. Because of inclusion of patients with consecutive presentation to provide a representative clinical sample, the exact numbers for sub-groups will not be controlled. The study population will include patients with comorbid conditions. The non-ADHD subgroup will include patients with other causes of attentional concerns, which may include other common psychiatric disorders, organic causes of attention problems (such as poor hearing, vision disturbances, remote head injury, substance abuse), and/or no diagnosis.

Criteria

Inclusion Criteria:

  • Subject willing to voluntarily participate in a research study that includes EEG collection and analysis.
  • Family/patient seeking comprehensive clinical evaluation for attention and/or behavior concerns.
  • Male or female at least 6 years of age and who will not be over 17.99 years of age upon admission to study.
  • Willing to stop any and all current psychiatric medications prior to or by entry into study.
  • Subject and parent (or legal representative) of an educational level and degree of understanding sufficient to communicate suitably with the investigator, rater and study coordinator.

Exclusion Criteria:

  • Previous diagnosis of mental retardation. IQ < 70 by previous records.
  • History of seizure disorder or of EEG abnormalities. On anticonvulsants for seizure control.
  • Metal plate or metal device in the head.
  • Suicide ideation or gesture and/or homicidal ideation or gesture.
  • Concomitant medications during participation in a research study. No prescription or nonprescription medications with psychoactive properties that may affect EEG (such as over-the-counter dietary supplements, pseudoephedrine, or phenylpropanolamine). No antipsychotics, no psychostimulants, no antidepressants. Washout of at least one week or longer depending on the medication and clinician's judgment. Medication used for medical reasons must be cleared by research staff with consideration of known effects on EEG.
  • Known serious medical problems (cardiovascular, hematological, liver, seizure disorder, renal, or chronic respiratory problems).
  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: NCT00595751

Locations
United States, Alabama
Harmonex
Dothan, Alabama, United States, 36303
United States, Colorado
Indian Crest Pediatrics
Westminster, Colorado, United States, 80021
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
Mercer University School of Medicine
Macon, Georgia, United States, 31207-0001
United States, Louisiana
LSU, HSC
New Orleans, Louisiana, United States, 70118
United States, New Jersey
Children's Specialized Hospital
Toms River, New Jersey, United States, 08755
United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
United States, Ohio
Rakesh Ranjan, MD & Associates
Beachwood, Ohio, United States, 44122
United States, Oklahoma
Oklahoma University Child Study Center
Oklahoma City, Oklahoma, United States, 73177
Eminence Research, LLC
Oklahoma City, Oklahoma, United States, 73139
Sponsors and Collaborators
Lexicor Medical Technology, LLC
Investigators
Study Director: Humberto Quintana, MD LSU, HSC
Study Chair: Steve Snyder, Ph.D. Lexicor Medical Technology, LLC
Principal Investigator: Humberto Quintana, MD LSU, HSC
  More Information

No publications provided

Responsible Party: Howard Merry, President, Lexicor Medical Technology, LLC
ClinicalTrials.gov Identifier: NCT00595751     History of Changes
Other Study ID Numbers: 004-1.6
Study First Received: January 7, 2008
Last Updated: July 29, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Lexicor Medical Technology, LLC:
ADHD, Attention Deficit Hyperactivity Disorder

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 29, 2014