Attention Deficit Hyperactivity Disorder (ADHD)NAT-INCT02407496
Neurophysiological Attention Test (NAT) for Objective Assessment of Attention Deficit Hyperactivity Disorder (ADHD)
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by Think Now Incorporated at 1 site in United States.
Trial summary
The purpose of this study is develop a new assessment tool for Attention Deficit-Hyperactivity Disorder (ADHD) and to then 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 (ADHD)
- What is being tested?
- Behavioral assessment and NAT EEG tests
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Sep 2015
- 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 greater Los Angeles area.
Who may be able to join
- Specific inclusion criteria for ADHD are:
- meet established DSM-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 wit the 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 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
1 site in 1 country.
About this study
The purpose of this study is develop a new assessment tool for Attention Deficit-Hyperactivity Disorder (ADHD) and to then 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 develop a novel approach and software for analyzing electroencephalography (EEG) data to identify biomarkers of ADHD. Then to test the ability of this 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.
- Being tested
- Behavioral assessment and NAT EEG tests
- 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.
Behavioral assessment and NAT EEG testsOther
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 Attention Deficit Hyperactivity Disorder (ADHD) Receives: Other: Behavioral assessment and NAT EEG tests | |
| Control | Healthy individuals without ADHD Receives: Other: Behavioral assessment and NAT EEG tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
NAT Slow Fluctuation 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 Controls.
Measured: A single measurement is made for each individual at DAY 1 - the time of the brain wave test.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJun 2014
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Think Now Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Gregory Simpson, Ph.D., Think Now Incorporated
- Investigators
- Gregory V Simpson, Ph.D., Principal investigator, Think Now, Inc.Mark S Cohen, Ph.D., Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407496
- Sponsor's protocol ID
- TNI-NAT-1
- Other IDs
- R43MH099709
- Acronym
- NAT-I
- Status last verified
- Dec 2020
- First submitted
- 27 Mar 2015
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Attention Test (NAT) for Objective Assessment of Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02407496
- Acronym / sponsor ID
- NAT-I / TNI-NAT-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Think Now IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- University of California, Los Angeles, National Institute of Mental Health (NIMH)
- Study start
- Jun 2014
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Apr 2015 (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 develop a new assessment tool for Attention Deficit-Hyperactivity Disorder (ADHD) and to then test its validity (i.e. ability to discriminate between individuals with ADHD and healthy controls).
Detailed description
The purpose of this study is to develop a novel approach and software for analyzing electroencephalography (EEG) data to identify biomarkers of ADHD. Then to test the ability of this 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 | – | Other: Behavioral assessment and NAT EEG testsAdults with Attention Deficit Hyperactivity Disorder (ADHD) |
| Control | – | Other: Behavioral assessment and NAT EEG testsHealthy individuals without ADHD |
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 greater Los Angeles area.
Key inclusion criteria (5 listed)
- Specific inclusion criteria for ADHD are:
Key exclusion criteria (7 listed)
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 |
|---|---|---|
| Behavioral assessment and NAT EEG testsIndividuals in both groups are asked to perform standard behavioral tests and an electroencephalography (EEG) test. | Other | ADHD, Control |
Primary outcome
NAT Slow Fluctuation Measure
Time frame: A single measurement is made for each individual at DAY 1 - the time of the brain wave test.
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 Controls.
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 10 Dec 2020.
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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.
Mark S Cohen, Ph.D. study director
University of California, Los Angeles
1 site 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 (ADHD), run by Think Now Incorporated at 1 site 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 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Measure (time frame: A single measurement is made for each individual at DAY 1 - the time of the brain wave test.). 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 10 Dec 2020.