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New Continuous Performance Tests (CPT) for the Diagnosis of Pediatric Attention Deficit/Hyperactivity Disorder (ADHD) (CPT)

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ClinicalTrials.gov Identifier: NCT00646464
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : March 1, 2018
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

Brief 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. 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.


Condition or disease
Attention Deficit Hyperactivity Disorder

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 Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Computerized Continuous Performance Test (CPT) for Diagnosing Pediatric Attention Deficit/Hyperactivity Disorder (ADHD)
Actual Study Start Date : February 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
2
Children 6-12 years old diagnosed as not suffering from ADHD
1
children 6-12 diagnosed as ADHD



Primary Outcome Measures :
  1. accurate diagnosis of ADHD [ Time Frame: one year ]

Secondary Outcome Measures :
  1. validation [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
6-12 year old children suspected as ADHD otherwise healthy
Criteria

Inclusion Criteria:

  • diagnosis of ADHD by the "gold standard" method

Exclusion Criteria:

  • Chronic use of medications, Psychiatric disorder, Abnormal cognitive function

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00646464


Locations
Israel
Neuro-Pediatric Unit, Hadassah-Hebrew University Medical Center Mount Scopus
Jerusalem, Israel, 91240
Neuro-Pediatric Unit, Hadassah-Hebrew University Medical Center
Jerusalem, Israel, 91240
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Itai Berger, MD Hadassah Medical Organization

Publications:
Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00646464     History of Changes
Other Study ID Numbers: 0052-08-HMO-CTIL
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: March 1, 2018
Last Verified: August 2009

Keywords provided by Hadassah Medical Organization:
CPT
ADHD

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms