CRCNJ Takes Part in New Enzyme Treatment for Autism

Courtesy of NJ.COM…
njarticleauthor

Could a dose of an enzyme, administered through food by the use of “sprinkles,” help reduce the symptoms of autism?

That possibility is being investigated in a clinical trial at two New Jersey locations. Both are looking for children ages 3 to 8 to be study participants.

The drug, called blüm, is based on research that showed children with autism often have a shortage of certain enzymes that result in the inability to digest protein.

That in turn affects the availability of amino acids, which are essential for brain function.

“There’s a growing body of research on the links between the gut and the brain, so there seems to be some connections there,” said Mark Mintz, the pediatrician running the study site at the Clinical Research Center of New Jersey, in Voorhees.

A second study site is in Toms River, at Children’s Specialized Hospital research center.

The goal of the treatment is to reduce irritability, agitation, and hyperactivity among the children who participate. A secondary effect might be to produce some improvement in social interaction, Mintz said.

The substance under study is a biologic, an enzyme instead of a drug. That means it’s comparable to Lactaid, the commercial product containing the lactase enzyme that people with lactose intolerance are lacking.

The study is a Phase III Food and Drug Administration clinical trial, which means the medicine has already proved to be safe.

This newest round of research is one in which some of the children will receive the medicine, while others will receive a placebo, or inert substance. Neither the researchers nor the parents will know which children got the drug until the study is concluded.

The biologic will be administered in the form of “sprinkles” that are put atop food. Parents will have to keep logs of a child’s behavior, and bring in a stool sample once a month.

The study lasts for 14 weeks and participation is free. Participants can also get reimbursed for travel costs as well.

Children will have an initial behavioral assessment to determine if they qualify. Mintz said in general the study is looking for children who have moderate-to-severe autism who are either non-verbal or minimally verbal, or who are already receiving services for their diagnosis.

The study, now beginning at 25 sites nationally, is being run by the biologic’s developer, Curemark, a drug research and development company.

At this time, it is limited to children ages 3 through 8.

“If you’re going to make a change in autism, it’s better to start earlier,” Mintz said.

Kathleen O’Brien may be reached at kobrien@njadvancemedia.com. Follow her on Twitter @OBrienLedger. Find NJ.com on Facebook.

CNNH Presents at ASET Neurotech Conference

Laura Szklarski, BS, R-EEG.T and Kimberly Catterall, R-EEG.T, Neurotechnologists at CNNH, presented a poster entitled “High Density Electroencephalography (HD-EEG) and Desensitization Techniques Improve Compliance Without Sedation or Restraint For Children and Adults with Behavioral Challenges,” at the American Society of Electroneurodiagnostic Technologists (ASET) 2016 Conference in Pittsburgh, PA last Thursday.

The poster educated the technologist community on High Density EEG and strategies to improve compliance for EEG with behaviorally challenged individuals without the need for sedation or restraint. The poster was extremely well-received and commended by the community, and it was evident that technologists are eager for strategies and assistance in avoiding the use of sedation and restraint for their patients. CNNH is a leader in providing quality neurodiagnostic testing for individuals who would otherwise be challenging and non-compliant in a typical hospital setting.

VIEW THE POSTER >>>

“I Love My Family” Music Therapy Song Performance

“My Family” was written and performed by Michael Smith, accompanied by Music Therapist Ai Nakatsuka, MT-BC, at our annual Music-Dance-Art Therapy recital showcase in 2016.

This song builds and builds to a wild emotional finish, stay to the end!

Michael has an interesting and touching story that makes his performance in this video all the more touching:

“Michael was placed into our home at the age of 2 months old and by 2 years old was diagnosed with Pervasive Developmental Disorder. At 8 years old medications he began medications and at 13 he was diagnosed with Bipolar Disorder. That year was horrific for all of us, but for Michael it was heartbreaking. We went through many doctor appointments, interventions, meds, programs, and spending many, many days and nights in the crisis unit at the hospital, battling insurance coverage to get him real help and literally begging anyone and everyone to help him. Then he had a complete psychotic break and was in the hospital for a month. There are not words to describe the hell he lived in at that time… Finally, we found some medications that helped him, but it was not enough for him to remain living in our home. He entered Bancroft and lives in a group home.

Michael started taking piano lessons when he was young but when the bipolar episodes began he had to stop. At Bancroft he began taking music therapy piano lessons. When the music therapist joined CNNH, Michael continued his lessons there and then began working with a new music therapist who had him write and sing some of his own works.

Through music he was able to calm himself when agitated and to come to terms with all that he has been through. Michael’s challenges in life will never be over but CNNH through their wonderful staff will always give him hope and peace in his world.”

-Barbara S.

US Dept Education Now Classifies ADHD as a Specific Disability

A recent letter sent to education professionals from the United States Department of Education clarifies new definitions for ADHD as a specific disability under the Americans With Disabilities Amendments Act, affording more protection from discrimination and more support for funding under Section 504 of the Rehabilitation Act of 1973.

View the original letter and accompanying ADHD resource guide >>>

Click the link above to view the original letter plus the accompanying ADHD resource guide, read below for the text of the letter without its references and footnotes:

Because the Americans with Disabilities Act Amendments Act (Amendments Act) clarified the broad scope and definition of the term “disability,” more students with ADHD are now clearly entitled to the protections under Section 504.

Over the past five fiscal years (2011-2015), the Department’s Office for Civil Rights (OCR) has received more than 16,000 complaints alleging discrimination on the basis of disability in elementary and secondary education programs. Approximately 2,000, or one in nine, of these complaints involved allegations of discrimination against a student with ADHD. In resolving such complaints, OCR has found that many teachers and administrators often take appropriate action to ensure that students with ADHD receive the protections to which they are entitled under Federal law, but many others are not familiar with this disorder, or how it could impact a student’s equal access to a school district’s program.

Through our enforcement efforts, we have learned that many students with ADHD are still experiencing academic and behavioral challenges in the educational setting, and that policy guidance is needed to ensure that those students are receiving a free appropriate public education (FAPE) as defined in the Department’s regulations implementing Section 504. OCR investigations have revealed that students with ADHD could be denied FAPE because of problems that school districts have in identifying and evaluating students who need special education or related services because of ADHD. Some of these problems are as follows:

 students never being referred for, or identified by the school district as needing, an evaluation to determine whether the student has a disability and needs special education or related services;
 students not being evaluated in a timely manner once identified as needing an evaluation; or
 school districts conducting inadequate evaluations of students.

In addition, even if properly identified, a student with ADHD who is determined to have a disability may not always receive required services. OCR, through its enforcement efforts, has observed that school districts fail to meet their Section 504 obligations when they:
 make inappropriate decisions about the regular or special education, related aids and services, or supplementary aids and services the student needs, and the appropriate setting in which to receive those services based on a misunderstanding of ADHD and the requirements of Section 504;
 fail to distribute relevant documentation to appropriate staff; or
 consider inappropriate administrative and financial burdens in selecting and providing appropriate related aids and services.

The failure to provide needed services to students with disabilities can result in serious social, emotional, and educational harm to the students involved. It can also unnecessarily drain school district and family resources if the school is ineffectually attempting to meet the needs of students with disabilities through failed interventions or disciplinary consequences.

As outlined in the Department’s regulations implementing Section 504, school districts must conduct individualized evaluations of students who, because of disability, including ADHD, need or are believed to need special education or related services, and must ensure that qualified students with disabilities receive appropriate services that are based on specific needs, not cost, and not based on stereotypes or generalized misunderstanding of a disability.4 These and other Section 504 obligations apply to all students with disabilities and are discussed in this guidance as they specifically pertain to students with ADHD.

Through this letter and the accompanying Resource Guide, OCR seeks to help educators, families, students, and other stakeholders better understand these laws as they pertain to students with ADHD in elementary and secondary schools in order to ensure that these students receive the regular or special education, related aids and services, or supplementary aids and services the student needs to be successful. I encourage you to use this information to ensure that your school district is properly evaluating and providing timely and appropriate services to students with ADHD.
Sincerely,
/s/
Catherine E. Lhamon
Assistant Secretary for Civil Rights