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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00646464
Other study ID # 0052-08-HMO-CTIL
Secondary ID
Status Completed
Phase N/A
First received March 25, 2008
Last updated February 28, 2018
Start date February 2008
Est. completion date December 2010

Study information

Verified date August 2009
Source Hadassah Medical Organization
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date December 2010
Est. primary completion date May 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 12 Years
Eligibility Inclusion Criteria:

- diagnosis of ADHD by the "gold standard" method

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms

  • Attention Deficit Disorder with Hyperactivity
  • Attention Deficit Hyperactivity Disorder
  • Disease
  • Hyperkinesis

Locations

Country Name City State
Israel Neuro-Pediatric Unit, Hadassah-Hebrew University Medical Center Jerusalem
Israel Neuro-Pediatric Unit, Hadassah-Hebrew University Medical Center Mount Scopus Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Lee 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. — View Citation

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. Epub 2005 Sep 28. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary accurate diagnosis of ADHD one year
Secondary validation one year
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