Attention Deficit Disorder With HyperactivityNEBANCT00595751
NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study
An observational study of Attention Deficit Disorder With Hyperactivity, run by Lexicor Medical Technology, LLC at 10 sites in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- How many people
- 300 participants
- Where
- 10 sitesUnited States
- Study dates
- Dec 2007to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Medical College of Georgia
Augusta, Georgia, 30912
Rakesh Ranjan, MD & Associates
Beachwood, Ohio, 44122
Harmonex
Dothan, Alabama, 36303
Mercer University School of Medicine
Macon, Georgia, 31207-0001
LSU, HSC
New Orleans, Louisiana, 70118
Eminence Research, LLC
Oklahoma City, Oklahoma, 73139
Oklahoma University Child Study Center
Oklahoma City, Oklahoma, 73177
SUNY Upstate Medical University
Syracuse, New York, 13210
Children's Specialized Hospital
Toms River, New Jersey, 08755
Indian Crest Pediatrics
Westminster, Colorado, 80021
About this study
Official title: Best Estimate Diagnosis Used to Evaluate EEG in Association With ADHD in a Multi-Site, Clinical Sample of Children and Adolescents
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.
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What is being measured
The primary outcome is the main question the study is designed to answer.
'Best Estimate Diagnosis' of ADHD applied in the intended population in settings with the intended users
Measured: At prensentation to clinic with attention or behavior problems
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lexicor Medical Technology, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Humberto Quintana, MD, Study director, LSU, HSCSteve Snyder, Ph.D., Study chair, Lexicor Medical Technology, LLCHumberto Quintana, MD, Principal investigator, LSU, HSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00595751
- Sponsor's protocol ID
- 004-1.6
- Acronym
- NEBA
- Status last verified
- Jul 2008
- First submitted
- 7 Jan 2008
- Last updated
- 30 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Best Estimate Diagnosis Used to Evaluate EEG in Association With ADHD in a Multi-Site, Clinical Sample of Children and Adolescents
- ClinicalTrials.gov ID
- NCT00595751
- Acronym / sponsor ID
- NEBA / 004-1.6
- Keywords
- ADHD, Attention Deficit Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Lexicor Medical Technology, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 16 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
'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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Humberto Quintana, MD study director
LSU, HSC
Steve Snyder, Ph.D. study chair
Lexicor Medical Technology, LLC
Humberto Quintana, MD principal investigator
LSU, HSC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity, run by Lexicor Medical Technology, LLC at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
'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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2008.