PUBLISHED: 2:54 PM on Wednesday, April 12, 2006
Company says brain scan can help diagnose disorder
Codi Scott can't concentrate at school. Her grades are slipping, and her mother is concerned.

"She shouldn't have to struggle her entire academic career," said Jeri Austin, Codi's mom.

The 9-year-old could be among the millions of American children diagnosed with attention deficit hyperactivity disorder, or ADHD.

To help in that determination, her doctor recommended a brain scan analysis using a new procedure being marketed by Augusta-based Lexicor Medical Technology Inc.

Using Codi's brain scan, Lexicor says, it can analyze brain waves to help determine whether she suffers from ADHD.

Electroencephalogram, or EEG, data has been around for decades, and it is often used to detect larger brain defects, such as seizure disorder.

However, Lexicor President Howard Merry said newer, more powerful computers are allowing doctors to use the scans to check for other conditions, such as ADHD.

Lexicor's process, named the NeuroLex Indicator Report Service, works like this: A child puts on an electrode cap, which collects data on brain wave activity. Doctors who use Lexicor send the data via Internet to the company's Augusta headquarters, where waves are compared with a database of similar-age children to look for abnormalities.

Research shows that children who suffer from ADHD exhibit different brain-wave patterns from those who don't, Merry said.

Lexicor has provided the service for nearly three years and has doctors in 26 states using the technology.

Since December, Dr. Warren Umansky has used Lexicor's technology in treating 40 child patients at Children's Medical Group. Ironically, his office is the only Augusta location using this technology.

Before this test, only observational and behavioral analysis was used in diagnosing ADHD, said Umansky, a child-development specialist.

Brain scans are most helpful in cases where it can be difficult to make a diagnosis because of differing opinions on the child's behavior from teachers, parents and other caregivers, he said.

In October, Lexicor submitted an application with the Food and Drug Administration to strengthen the credibility of its product.

Currently, Lexicor can market itself only to doctors as an EEG service.

With FDA approval, Lexicor will be able to explicitly state it "aids in the assessment of ADHD," Merry said.

"With the claim, it will be much easier for us," he said.

Most of Lexicor's current customers are specialists, such as child psychologists, who are more familiar with the use of EEG technology in ADHD assessments, Merry said.

With FDA approval, Lexicor could better market the product to primary care physicians, he said.

In 2003, Lexicor received a warning letter from the FDA because the company's management team at the time claimed the technology could diagnose ADHD, Merry said.

"That's not even close to the goal of what we're doing," he said.

"People responsible for the claims are no longer in management positions at the company."

Analyzing brain scans is not meant to serve as conclusive evidence a child has ADHD, he said.

Other factors should be used in conjunction with the test, including parent and teacher testimonials and behavioral analysis.

"The group before us did things the sloppy way. We cleaned it up to do things the right way," Merry said.

The new management also started a clinical validation study through Louisiana State University and the Medical College of Georgia to research how brain scan data could aid in ADHD assessment.

The study results were included in the FDA application.

Merry said he could not yet comment on the findings but did say he was "happy about it." He said he expects an FDA ruling by July.

ADHD is not easy to diagnose, and it remains a controversial topic with concerns over diagnosis.

Merry said Lexicor provides a service that helps eliminate some of this uncertainty.

The technology remains controversial, however, with some doctors questioning its efficacy. Those days will soon be over, Merry predicts.

"The day is coming when the door is going to be blown wide open," he said.

Lexicor said it has plans to use EEG scans to help diagnose other disorders, including dementia, Alzheimer's, bipolar disorder and depression.