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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00646464
First received: March 25, 2008
Last updated: August 10, 2009
Last verified: August 2009
  Purpose

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
Attention Deficit Hyperactivity Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Computerized Continuous Performance Test (CPT) for Diagnosing Pediatric Attention Deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • accurate diagnosis of ADHD [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • validation [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 500
Study Start Date: February 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
2
Children 6-12 years old diagnosed as not suffering from ADHD
1
children 6-12 diagnosed as ADHD

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.

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00646464

Contacts
Contact: Itai Berger, MD +972-2-5844751 itberg@hadassah.org.il
Contact: Liora Shiloni +972-2-5845034 sliora@hadassah.org.il

Locations
Israel
Neuro-Pediatric Unit, Hadassah-Hebrew University Medical Center Recruiting
Jerusalem, Israel, 91240
Contact: Itai Berger, MD    +972-2-5844751    itberg@hadassah.org.il   
Contact: Liora Shiloni    +972-2-5845034    sliora@hadassah.org.il   
Principal Investigator: Itai Berger, MD         
Sub-Investigator: Nir Yachin         
Neuro-Pediatric Unit, Hadassah-Hebrew University Medical Center Mount Scopus Recruiting
Jerusalem, Israel, 91240
Contact: Itai Berger, MD    +972-2-5844751    itberg@hadassa.org.il   
Contact: Liora Shiloni    +972-2-5845034    sliora@hadassah.org.il   
Principal Investigator: Itai Berger, MD         
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Itai Berger, MD Hadassah Medical Organization
  More Information

Publications:
Responsible Party: Itai Berger MD, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00646464     History of Changes
Other Study ID Numbers: 0052-08-HMO-CTIL
Study First Received: March 25, 2008
Last Updated: August 10, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
CPT
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014