Attention Deficit Hyperactivity DisorderNAT-IINCT02756286
Neurophysiological Attention Test (NAT) for Objective Assessment of Adult ADHD
An observational study of Attention Deficit Hyperactivity Disorder, run by Think Now Incorporated at 3 sites in United States.
Trial summary
The purpose of this study is to refine a new assessment tool for Attention Deficit/Hyperactivity Disorder (ADHD) and then to test its validity (i.e. ability to discriminate between individuals with ADHD and healthy controls. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- NAT electroencephalography (EEG) test
- How many people
- 258 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jan 2017to 5 Jul 2018
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults with Attention Deficit Hyperactivity Disorder (ADHD) from local clinics, clinicians, ADHD community resources in the area of each of the three participating Universities (UCLA, UCB, OHSU)
Who may be able to join
- Specific inclusion criteria for ADHD are:
- meet established Diagnositic and Statistical Manual-5 criteria for ADHD predominately inattentive or combined subtype with clinically significant levels of impairment, diagnosed by structured clinical interview, the Mini International Neuropsychiatric Interview, and corroborating information
- Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
- no lifetime history of DSM-5 bipolar disorder, psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse, or substance dependence (except nicotine) as assessed with the Mini International Neuropsychiatric Interview (MINI).
- able in the opinion of the investigator to complete all required study procedures.
Who cannot join
- History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
- history of any general medical condition likely to require chronic use of medication with identified central nervous system (CNS) effects suspected to alter cognitive performance
- history of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
- serious oxygen deprivation
- current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants
- current untreated psychopathology which is rated to be primary in terms of severity (greater than ADHD severity)
- current treatment with guanfacine.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of California Berkeley
Berkeley, California, 94720
UCLA Semel Institute
Los Angeles, California, 90095
Oregon Health & Science University
Portland, Oregon, 97239
About this study
The purpose of this study is to refine a new assessment tool for Attention Deficit/Hyperactivity Disorder (ADHD) and then to test its validity (i.e. ability to discriminate between individuals with ADHD and healthy controls.
Read the detailed description
The purpose of this study is to build upon the success the novel approach and software for analyzing electroencephalography (EEG) data to identify biomarkers of ADHD in adults by further refining the method. Then to test the ability of this new assessment tool to differentiate between adults with ADHD and healthy controls by comparing the classification accuracy of the metrics from the new tool to the classification accuracy of existing behavioral tests for ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- NAT electroencephalography (EEG) test
- Keywords
- Electroencephalography, Attention
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAT electroencephalography (EEG) testOther
Individuals in both groups are asked to perform standard behavioral tests and an electroencephalography (EEG) test.
| Study group | Role | What they receive |
|---|---|---|
| ADHD: Adults with ADHD | NAT electroencephalography (EEG) test Receives: Other: NAT electroencephalography (EEG) test | |
| Controls: Healthy adults without ADHD | NAT electroencephalography (EEG) test Receives: Other: NAT electroencephalography (EEG) test |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAT Slow Fluctuation Test and Retest to assess change for Test Replicability
The NAT EEG test simultaneously generates 2 EEG values and 1 behavioral value that are used together as an assessment metric for ADHD. This is a one-time measure to assess its magnitude in ADHD vs Control.
Measured: A single measurement is made for each individual at DAY 1 - the time of the brain wave (EEG) test; and a single measure is made again in each individual at least 30 days later (DAY 2) to identify any differences, to assess replicability of the measure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start1 Jan 2017
- Primary completion1 Jun 2018
- Study completion5 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Think Now Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, University of California, Berkeley, Oregon Health and Science University, National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Gregory Simpson, Ph.D., Think Now Incorporated
- Investigators
- Gregory V Simpson, Ph.D., Principal investigator, Think Now, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02756286
- Sponsor's protocol ID
- TNI-NAT-II
- Other IDs
- R44MH099709
- Acronym
- NAT-II
- Status last verified
- Sep 2018
- First submitted
- 12 Nov 2015
- Last updated
- 19 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Attention Test (NAT) for Objective Assessment of Adult ADHD
- ClinicalTrials.gov ID
- NCT02756286
- Acronym / sponsor ID
- NAT-II / TNI-NAT-II
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Electroencephalography, Attention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Think Now IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, University of California, Berkeley, Oregon Health and Science University, National Institute of Mental Health (NIMH)
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 5 Jul 2018 (actual)
- First posted
- 29 Apr 2016 (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 purpose of this study is to refine a new assessment tool for Attention Deficit/Hyperactivity Disorder (ADHD) and then to test its validity (i.e. ability to discriminate between individuals with ADHD and healthy controls.
Detailed description
The purpose of this study is to build upon the success the novel approach and software for analyzing electroencephalography (EEG) data to identify biomarkers of ADHD in adults by further refining the method. Then to test the ability of this new assessment tool to differentiate between adults with ADHD and healthy controls by comparing the classification accuracy of the metrics from the new tool to the classification accuracy of existing behavioral tests for ADHD.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD: Adults with ADHD | – | Other: NAT electroencephalography (EEG) testNAT electroencephalography (EEG) test |
| Controls: Healthy adults without ADHD | – | Other: NAT electroencephalography (EEG) testNAT electroencephalography (EEG) test |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults with Attention Deficit Hyperactivity Disorder (ADHD) from local clinics, clinicians, ADHD community resources in the area of each of the three participating Universities (UCLA, UCB, OHSU)
Key inclusion criteria (5 listed)
- meet established Diagnositic and Statistical Manual-5 criteria for ADHD predominately inattentive or combined subtype with clinically significant levels of impairment, diagnosed by structured clinical interview, the Mini International Neuropsychiatric Interview, and corroborating information
- Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
- no lifetime history of DSM-5 bipolar disorder, psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse, or substance dependence (except nicotine) as assessed with the Mini International Neuropsychiatric Interview (MINI).
- able in the opinion of the investigator to complete all required study procedures.
Key exclusion criteria (7 listed)
- History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
- history of any general medical condition likely to require chronic use of medication with identified central nervous system (CNS) effects suspected to alter cognitive performance
- history of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
- serious oxygen deprivation
- current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NAT electroencephalography (EEG) testIndividuals in both groups are asked to perform standard behavioral tests and an electroencephalography (EEG) test. | Other | ADHD: Adults with ADHD, Controls: Healthy adults without ADHD |
Primary outcome
NAT Slow Fluctuation Test and Retest to assess change for Test Replicability
Time frame: A single measurement is made for each individual at DAY 1 - the time of the brain wave (EEG) test; and a single measure is made again in each individual at least 30 days later (DAY 2) to identify any differences, to assess replicability of the measure.
The NAT EEG test simultaneously generates 2 EEG values and 1 behavioral value that are used together as an assessment metric for ADHD. This is a one-time measure to assess its magnitude in ADHD vs Control.
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 19 Sep 2018.
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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.
Gregory V Simpson, Ph.D. principal investigator
Think Now, Inc.
3 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 Hyperactivity Disorder, run by Think Now Incorporated at 3 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 7 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 19 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
NAT Slow Fluctuation Test and Retest to assess change for Test Replicability (time frame: A single measurement is made for each individual at DAY 1 - the time of the brain wave (EEG) test; and a single measure is made again in each individual at least 30 days later (DAY 2) to identify any differences, to assess replicability of the measure.). 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 19 Sep 2018.