Attention Deficit Hyperactivity DisorderCPTNCT00646464
New Continuous Performance Tests (CPT) for the Diagnosis of Pediatric Attention Deficit/Hyperactivity Disorder (ADHD)
An observational study of Attention Deficit Hyperactivity Disorder, run by Hadassah Medical Organization at 2 sites in Israel.
Trial summary
Computerized continuous performance tests (CPT) considered the "gold standard" for diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD. This type of tests are based mainly on visual performance. The available tests suffer from high false negative errors. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 500 participants
- Where
- 2 sitesIsrael
- Study dates
- Feb 2008to Dec 2010
- 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 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 6-12 year old children suspected as ADHD otherwise healthy
Who may be able to join
- diagnosis of ADHD by the "gold standard" method
Who cannot join
- Chronic use of medications, Psychiatric disorder, Abnormal cognitive function
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Neuro-Pediatric Unit, Hadassah-Hebrew University Medical Center Mount Scopus
Jerusalem, 91240
Neuro-Pediatric Unit, Hadassah-Hebrew University Medical Center
Jerusalem, 91240
About this study
Official title: New Computerized Continuous Performance Test (CPT) for Diagnosing Pediatric Attention Deficit/Hyperactivity Disorder (ADHD)
Computerized continuous performance tests (CPT) considered the "gold standard" for diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD.
This type of tests are based mainly on visual performance. The available tests suffer from high false negative errors. This raises questions regarding their ability to correctly diagnose ADHD.
Read more
With the expanding knowledge regarding the neurobiological basis in ADHD we have learned that attention is not a general property of the whole brain, but involves several coordinated networks. This knowledge promoted us to the stage in which we can recognize different types of attention domains.
Our diagnosis test can separate between the different attention abilities and provide specific diagnosis. Our program is individually fits for the specific child difficulties and covers a wider range of needs. So, it can be helpful to a larger variety of children with different needs.
Read the detailed description
Computerized continuous performance tests (CPT) considered the "gold standard" for diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) and are widely used.
This type of tests measures the number of correctly detected stimuli as well as response time. The diagnosis in this tests based mainly on visual performance. The available tests in the market suffer from high false negative errors. In some subgroups of children the error can be false positive. All this raises questions regarding their ability to correctly diagnose ADHD. There are also doubts regarding the validity of these tests. From the medical literature and from our own experience it seems that with the current tests as much as third of the children who fulfill DSM criteria for ADHD can escape detection.
With the expanding knowledge regarding the neurobiological basis in ADHD we have learned that attention is not a general property of the whole brain, but involves several coordinated networks. These networks must be orchestrated in order to perform normally in three main domains of attention = alertness, orientation and executive function. This raised the need for a better, more accurate and valid computerized test.
This knowledge promoted us to the stage in which we can recognize different types of attention domains. We can separate between - visual attention, auditory attention, spatial attention, integrated attention, sustained attention, covert and overt attention, working memory, the ability to integrate and disintegrate attention, attention span, focusing, impulsivity and response time. Different people have different "subtypes" of ADHD. The individual separation and ability to focus on specific difficulties influence diagnosis process and treatment methods.
Our diagnosis test can separate between the different attention abilities and provide the parents with specific diagnosis of their child and in this way direct them to the appropriate diagnosis and treatment. Moreover, we expect its falls negative and positive errors to be negligible.
The next phase - involves training and exercise. It is proved that training can improve attention.
We have also developed a computerized training program for children. This program is based on the same platform as the diagnosis test and can recommend on training in the individual difficulties of the specific child.
Other programs are already distributed in the market for the same propose. The other programs focus on improving a general specific skill and ignore (or can not focus) on the specific need of the individual. They can try to improve working memory which is only one aspect in attention domain. Or, based on improving visual-motor skill, which is a skill that can be improved in regular computer games and again focus on a specific short range difficulty. In many children ADHD symptoms and signs are due to other sources. For them improving working memory or visual-motor skills will not change their every day performance.
Our program is better since it is individually fits for the specific child difficulties and covers a wider range of needs. So, it can be helpful to a larger variety of children with different needs.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- CPT, ADHD
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Children 6-12 years old diagnosed as not suffering from ADHD | |
| 1 | children 6-12 diagnosed as ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
accurate diagnosis of ADHD
Measured: one year
Secondary outcomes (1)
validation
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionMay 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Itai Berger, MD, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00646464
- Sponsor's protocol ID
- 0052-08-HMO-CTIL
- Acronym
- CPT
- Status last verified
- Aug 2009
- First submitted
- 25 Mar 2008
- Last updated
- 1 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Rueda MR, Rothbart MK, McCandliss BD, Saccomanno L, Posner MI. Training, maturation, and genetic influences on the development of executive attention. Proc Natl Acad Sci U S A. 2005 Oct 11;102(41):14931-6. doi: 10.1073/pnas.0506897102. Epub 2005 Sep 28.
PubMed 16192352Lee HJ, Cho S, Shin MS. Supporting diagnosis of attention-deficit hyperactive disorder with novelty detection. Artif Intell Med. 2008 Mar;42(3):199-212. doi: 10.1016/j.artmed.2007.11.001. Epub 2008 Jan 9.
PubMed 18187311
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Computerized Continuous Performance Test (CPT) for Diagnosing Pediatric Attention Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT00646464
- Acronym / sponsor ID
- CPT / 0052-08-HMO-CTIL
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- CPT, ADHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Feb 2008 (actual)
- Primary completion
- May 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 28 Mar 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.
Computerized continuous performance tests (CPT) considered the "gold standard" for diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD.
This type of tests are based mainly on visual performance. The available tests suffer from high false negative errors. This raises questions regarding their ability to correctly diagnose ADHD.
With the expanding knowledge regarding the neurobiological basis in ADHD we have learned that attention is not a general property of the whole brain, but involves several coordinated networks. This knowledge promoted us to the stage in which we can recognize different types of attention domains.
Our diagnosis test can separate between the different attention abilities and provide specific diagnosis. Our program is individually fits for the specific child difficulties and covers a wider range of needs. So, it can be helpful to a larger variety of children with different needs.
Detailed description
Computerized continuous performance tests (CPT) considered the "gold standard" for diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) and are widely used.
This type of tests measures the number of correctly detected stimuli as well as response time. The diagnosis in this tests based mainly on visual performance. The available tests in the market suffer from high false negative errors. In some subgroups of children the error can be false positive. All this raises questions regarding their ability to correctly diagnose ADHD. There are also doubts regarding the validity of these tests. From the medical literature and from our own experience it seems that with the current tests as much as third of the children who fulfill DSM criteria for ADHD can escape detection.
With the expanding knowledge regarding the neurobiological basis in ADHD we have learned that attention is not a general property of the whole brain, but involves several coordinated networks. These networks must be orchestrated in order to perform normally in three main domains of attention = alertness, orientation and executive function. This raised the need for a better, more accurate and valid computerized test.
This knowledge promoted us to the stage in which we can recognize different types of attention domains. We can separate between - visual attention, auditory attention, spatial attention, integrated attention, sustained attention, covert and overt attention, working memory, the ability to integrate and disintegrate attention, attention span, focusing, impulsivity and response time. Different people have different "subtypes" of ADHD. The individual separation and ability to focus on specific difficulties influence diagnosis process and treatment methods.
Our diagnosis test can separate between the different attention abilities and provide the parents with specific diagnosis of their child and in this way direct them to the appropriate diagnosis and treatment. Moreover, we expect its falls negative and positive errors to be negligible.
The next phase - involves training and exercise. It is proved that training can improve attention.
We have also developed a computerized training program for children. This program is based on the same platform as the diagnosis test and can recommend on training in the individual difficulties of the specific child.
Other programs are already distributed in the market for the same propose. The other programs focus on improving a general specific skill and ignore (or can not focus) on the specific need of the individual. They can try to improve working memory which is only one aspect in attention domain. Or, based on improving visual-motor skill, which is a skill that can be improved in regular computer games and again focus on a specific short range difficulty. In many children ADHD symptoms and signs are due to other sources. For them improving working memory or visual-motor skills will not change their every day performance.
Our program is better since it is individually fits for the specific child difficulties and covers a wider range of needs. So, it can be helpful to a larger variety of children with different needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | – | –Children 6-12 years old diagnosed as not suffering from ADHD |
| 1 | – | –children 6-12 diagnosed as ADHD |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 6-12 year old children suspected as ADHD otherwise healthy
Key inclusion criteria (1 listed)
- diagnosis of ADHD by the "gold standard" method
Key exclusion criteria (1 listed)
- Chronic use of medications, Psychiatric disorder, Abnormal cognitive function
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
accurate diagnosis of ADHD
Time frame: one year
1 secondary outcome
validation
Time frame: one year
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 1 Mar 2018.
- Background: PubMed 16192352Rueda MR, Rothbart MK, McCandliss BD, Saccomanno L, Posner MI. Training, maturation, and genetic influences on the development of executive attention. Proc Natl Acad Sci U S A. 2005 Oct 11;102(41):14931-6. doi: 10.1073/pnas.0506897102. Epub 2005 Sep 28.
- Background: PubMed 18187311Lee HJ, Cho S, Shin MS. Supporting diagnosis of attention-deficit hyperactive disorder with novelty detection. Artif Intell Med. 2008 Mar;42(3):199-212. doi: 10.1016/j.artmed.2007.11.001. Epub 2008 Jan 9.
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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.
Itai Berger, MD principal investigator
Hadassah Medical Organization
2 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 Hadassah Medical Organization at 2 sites in Israel.
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 1 inclusion and 1 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 1 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
accurate diagnosis of ADHD (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00646464, which also lists 2 linked publications.
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 1 Mar 2018.