Accepted into the PANDAS/AUTISM study!
One of my friends from my local PANDAS moms group mentioned at our last meeting that there was a new study that investigates the relationship between Autism and auto-immune disorders such as PANDAS. She forwarded me the contact information a couple of weeks ago, and I submitted the following letter:
Dear Sean,
I know you are in the process of compiling candidates for the Anti-Neuronal Autoantibodies in PANDAS and Autism Spectrum Disorders study. My son, Hunter, fits your criteria perfectly. Here is a brief history of the journey we have been on for the past 3 1/2 years.
In November 2009, at the age of 17 months, Hunter contracted an infection (assuming was strep), with a 104 fever, while out of state and was taken to urgent care where he was prescribed azithromycin and had a full body reaction to the medication (or it has been hypothesized possible scarlet fever rash). After given a five day treatment of steroids to combat the reaction, Hunter started an eye blinking tic. Two weeks later, he started walking on his toes, and other issues began to develop (detesting loud noises, arm flapping, decreased fine motor skills). His language never regressed. An EEG was completed to rule out seizures, which yielded normal results. Following the eye tic, he also started to flap his arms- we are not sure if it started as a large motor tic that morphed into a stim, but the repetitive behavior has remained. Over the next year, he became socially withdrawn and his tantrums and irritability increased. In December of 2011, he was diagnosed with Pervasive Developmental Disorder. We knew that even though he had behaviors to support this diagnosis, there was an underlying medical reason for the shift in our child; PDD-NOS is a behavioral diagnosis, not a medical diagnosis. If a patient exhibits traits and characteristics of behaviors consistent with the diagnostic criteria for Autism, then a diagnosis can be made. However, several of the characteristics that my son exhibited would cross-over to the symptoms significant in an autoimmune response like he had, especially since it occurred at a critical period of development (17 months).
An MRI (completed 10/12/12) and an EEG (completed 10/18/12) both indicated normal results. Blood work has shown highly elevated strep titers (Anti-D Nase B Strep Antibodies), CoxsackieA IgG, Mycoplasma, and HHV6, even without recent exposure. Hunter was also diagnosed with Vitiligo by Dr. G, a Pediatric Dermatologist in XXXX. This autoimmune disorder developed post-initial infection, with a patch on his hip. The Vitiligo now has spread to several areas on his face and body. He has also been unable to tolerate gluten and wheat, another autoimmune reaction that has started since the initial illness.
Hunter started in-home ABA therapy in the fall of 2012, with up to 20 hours per week. In addition, he began the Intensive Outpatient Program at XXXX for six hours per week. He contracted strep in February and an immense regression occurred, where symptoms resurfaced that had previously been extinguished. Behavioral data supports this regression and their inability to stabilize his behavior, even three months post infection.
Dr. G, Pediatric Neuroimmunologist, after attempting to find a specific antibody that was "confused" (he had hypothesized NMDA encephalitis, which was negative), recommended a steroid burst in June of 2013 to determine if a temporary cessation of the production of antibodies would decrease inflammation and accompanying behaviors. Administration of Solu-Medral (500mg) for five subsequent days yielded positive results. Aggression, irritability, oppositional defiant-type behaviors, acute separation anxiety, sensory sensitivity to noises and touch, anxiety, OCD, behavioral regression, and deterioration in handwriting all decreased, with blind data to support these changes. Our ABA therapists were in the dark to the timing and nature of the steroids; when data was presented after two months post-steroid, it was clear and indicative of an immunodeficiency. The steroids reduced inflammation and temporarily stopped the production of antibodies.
I am a speech-language pathologist, who has worked with children with Autism for over eleven years. We have looked back at videos, my own language assessments, and pictures; this bright, social child had 11 true words and 11 signs at one year of age. My colleagues were baffled at the change that occurred, and consistently reassured me in the beginning that my son didn't have Autism. As the autoimmune reactions continued to spiral, so did his traits and behaviors; we now have a five-year-old child, who was completely neurotypical, with an Autism Spectrum Disorder. I have actually talked with Dr. Cunningham in the past...when I learned of PANDAS, I reached out to as many professionals as I could find to assist in my son's medical needs. We had a lengthy conversation and she informed me of the Cunningham Panel, which is on our list of tests to be completed. Please consider my son, Hunter, for your study. I have kept meticulous notes and data over the past few years and would be so appreciative of Dr. Cunningham and her staff's expertise.
I received an email today that informed us we were accepted and were invited to join the study (after signing consent and HIPPA). We would submit bloodwork, and they would attempt to find the characterizing antibodies (a protein in the blood which fights infection and or may cause inflammation). Dr. Madeleine Cunningham is the original creator of the "Cunningham Panel"- she found specific antibodies to test to determine if your child was "not likely," or "likely," PANS. I am actually in awe that we were one of 40 patients selected for the study...and it also reaffirms in my mind that we are on the right track. The researcher who developed the test for PANDAS chose us to participate in her PANDAS/AU study.
Here is the official consent:
UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER and OU MEDICAL CENTER
Individual's Consent for Participation in Research Project
Title: “Anti-Neuronal Antibodies in PANDAS and Autism Spectrum Disorders”
Sponsor: Autism Speaks Trailblazer Award
Principal Investigator: Madeleine W. Cunningham Co-investigator: Bonnie J. McBride
This is a research study. Research studies involve only individuals who choose to participate. Please take your time to make your decision. Discuss this with your family and friends.
Why Have I Been Asked to Participate In This Study? You and/ or your child are being asked to participate in this study because your child has a diagnosis of autism spectrum disorder (ASD) or a related diagnosis. Your child may display behaviors associated with an obsessive compulsive disorder and/or tics (i.e., uncontrolled movements of the body). Also, your child may be related to someone with these behaviors or your child is a typically developing volunteer and has had uncomplicated streptococcal pharyngitis (e.g. strep throat). Other disorders that may affect the brain are also included in the study such as pediatric autoimmune disorder associated with streptococci (PANDAS), Pediatric Acute Neurologic Syndrome(PANS), Tourette’s Syndrome, other similar related disorders with tic or behavioral OCD symptoms and/or autistic behaviors. This research project is sponsored by Autism Speaks and will be carried out by Madeleine Cunningham, PhD and Bonnie McBride, PhD.
Why is this study being done? This study involves research for the purpose of identifying and characterizing antibodies (a protein in the blood which fights infection or may cause inflammation). We are trying to find out if these antibodies could affect the brain and cause neurological problems, behavioral, emotional or movement problems. This research also involves genetic research.
What procedures are involved in the study? If you volunteer for this study, your child will have blood drawn using a syringe and needle or appropriate blood collection tube equipped with a needle. This procedure is just like giving blood at a doctor’s office or when someone donates blood. No more than 20 ml or 2 teaspoons of blood will be drawn from a child and no more than 500 ml or (equal to a unit of blood as given when donating blood) will be drawn from an adult. The blood will be used to produce antibodies and B cell lines. The gene (part of your DNA) that is producing antibody or the B cell receptor will be identified. Dr. Cunningham may inject a portion of your DNA into a mouse to produce
IRB NUMBER: 3115 IRB APPROVAL DATE: 06/26/2013 IRB EXPIRATION DATE: 05/31/2014
mice which produce your antibody or B cell receptor (transgenic mice). Dr. Cunningham may try to keep your B cells alive indefinitely. This is called a B cell line. If a cell line or transgenic mice are created using your child’s blood, it may be shared with other investigators; however, your identity will not be revealed to them. There is no intent to use your blood or any cell line derived from your blood for commercial purposes or financial gain.
We will keep some of your child’s blood that is left over for future research. This blood will be placed in a tissue bank (a special freezer) together with blood from other individuals who have donated blood for this study. This tissue bank is located at OUHSC. Your blood will be stored indefinitely.
In addition, we would like to ask you some questions about your child and how he or she behaves and how he/she is progressing. You will be asked to complete a questionnaire that will take approximately 20 minutes.
Labeling of Yours or Your Child’s Specimens You and/or child’s blood will not be labeled with your child’s name or other information that would identify them directly. Instead, it will have a unique code that allows for it to be linked to some of your records information at our office. This link means that your specimen can be identified but only indirectly. This helps protect your personal information.
What Sort of Research Will Be Done On My Child’s Tissue? Your child’s blood/tissue may be used by various researchers, including the Principal Investigator, Madeleine W. Cunningham, Bonnie J. McBride, and other researchers here at the University of Oklahoma Health Sciences Center. Your child’s tissue may be used by researchers to learn more about neurological and possibly other diseases. Your child’s blood/tissue may be used for genetic research (to learn about diseases that are passed along in families). Future use of your blood/tissue may involve as yet undiscovered technologies.
How many people will take part in the study? No more than 40 individuals will participate in this study.
What are the benefits of this study? There is no direct benefit to you or your child. Results of the study will help us understand if autism or autistic behaviors can be associated with antibodies against parts of the brain and also if autism and PANDAS/PANS can be present together in the same individual. The results may lead to better ways of diagnosis and treatment of autism spectrum disorders, autistic-like behaviors, movement and tic disorders, obsessive compulsive disorder (OCD), as well as other autoimmune-related neurological and neuropsychiatric diseases.
*********************************************************************************
So here we are....had a great two days at school, followed by an extremely rough day today that included an hour and a half of tantrums, hitting, yelling, pinching, eloping, pulling hair, knocking glasses off of the teacher...
It honestly baffles me how he can be a complete angel one day- chasing his brother up the stairs, yelling "Race ya!",asking to play with Paige, looking me directly in the eyes to ask real questions... and then a raging child the next day. However, that is enough to remind me that inflammation is real-
it may be cruel, but it is real.
And it is a good reminder for me to keep fighting, keep advocating, keep praying, and raise awareness for this cruel, real disorder.
"I Belong"
http://www.youtube.com/watch?v=fU0pK85Xp9g
Dear Sean,
I know you are in the process of compiling candidates for the Anti-Neuronal Autoantibodies in PANDAS and Autism Spectrum Disorders study. My son, Hunter, fits your criteria perfectly. Here is a brief history of the journey we have been on for the past 3 1/2 years.
In November 2009, at the age of 17 months, Hunter contracted an infection (assuming was strep), with a 104 fever, while out of state and was taken to urgent care where he was prescribed azithromycin and had a full body reaction to the medication (or it has been hypothesized possible scarlet fever rash). After given a five day treatment of steroids to combat the reaction, Hunter started an eye blinking tic. Two weeks later, he started walking on his toes, and other issues began to develop (detesting loud noises, arm flapping, decreased fine motor skills). His language never regressed. An EEG was completed to rule out seizures, which yielded normal results. Following the eye tic, he also started to flap his arms- we are not sure if it started as a large motor tic that morphed into a stim, but the repetitive behavior has remained. Over the next year, he became socially withdrawn and his tantrums and irritability increased. In December of 2011, he was diagnosed with Pervasive Developmental Disorder. We knew that even though he had behaviors to support this diagnosis, there was an underlying medical reason for the shift in our child; PDD-NOS is a behavioral diagnosis, not a medical diagnosis. If a patient exhibits traits and characteristics of behaviors consistent with the diagnostic criteria for Autism, then a diagnosis can be made. However, several of the characteristics that my son exhibited would cross-over to the symptoms significant in an autoimmune response like he had, especially since it occurred at a critical period of development (17 months).
An MRI (completed 10/12/12) and an EEG (completed 10/18/12) both indicated normal results. Blood work has shown highly elevated strep titers (Anti-D Nase B Strep Antibodies), CoxsackieA IgG, Mycoplasma, and HHV6, even without recent exposure. Hunter was also diagnosed with Vitiligo by Dr. G, a Pediatric Dermatologist in XXXX. This autoimmune disorder developed post-initial infection, with a patch on his hip. The Vitiligo now has spread to several areas on his face and body. He has also been unable to tolerate gluten and wheat, another autoimmune reaction that has started since the initial illness.
Hunter started in-home ABA therapy in the fall of 2012, with up to 20 hours per week. In addition, he began the Intensive Outpatient Program at XXXX for six hours per week. He contracted strep in February and an immense regression occurred, where symptoms resurfaced that had previously been extinguished. Behavioral data supports this regression and their inability to stabilize his behavior, even three months post infection.
Dr. G, Pediatric Neuroimmunologist, after attempting to find a specific antibody that was "confused" (he had hypothesized NMDA encephalitis, which was negative), recommended a steroid burst in June of 2013 to determine if a temporary cessation of the production of antibodies would decrease inflammation and accompanying behaviors. Administration of Solu-Medral (500mg) for five subsequent days yielded positive results. Aggression, irritability, oppositional defiant-type behaviors, acute separation anxiety, sensory sensitivity to noises and touch, anxiety, OCD, behavioral regression, and deterioration in handwriting all decreased, with blind data to support these changes. Our ABA therapists were in the dark to the timing and nature of the steroids; when data was presented after two months post-steroid, it was clear and indicative of an immunodeficiency. The steroids reduced inflammation and temporarily stopped the production of antibodies.
I am a speech-language pathologist, who has worked with children with Autism for over eleven years. We have looked back at videos, my own language assessments, and pictures; this bright, social child had 11 true words and 11 signs at one year of age. My colleagues were baffled at the change that occurred, and consistently reassured me in the beginning that my son didn't have Autism. As the autoimmune reactions continued to spiral, so did his traits and behaviors; we now have a five-year-old child, who was completely neurotypical, with an Autism Spectrum Disorder. I have actually talked with Dr. Cunningham in the past...when I learned of PANDAS, I reached out to as many professionals as I could find to assist in my son's medical needs. We had a lengthy conversation and she informed me of the Cunningham Panel, which is on our list of tests to be completed. Please consider my son, Hunter, for your study. I have kept meticulous notes and data over the past few years and would be so appreciative of Dr. Cunningham and her staff's expertise.
I received an email today that informed us we were accepted and were invited to join the study (after signing consent and HIPPA). We would submit bloodwork, and they would attempt to find the characterizing antibodies (a protein in the blood which fights infection and or may cause inflammation). Dr. Madeleine Cunningham is the original creator of the "Cunningham Panel"- she found specific antibodies to test to determine if your child was "not likely," or "likely," PANS. I am actually in awe that we were one of 40 patients selected for the study...and it also reaffirms in my mind that we are on the right track. The researcher who developed the test for PANDAS chose us to participate in her PANDAS/AU study.
Here is the official consent:
UNIVERSITY OF OKLAHOMA HEALTH SCIENCES CENTER and OU MEDICAL CENTER
Individual's Consent for Participation in Research Project
Title: “Anti-Neuronal Antibodies in PANDAS and Autism Spectrum Disorders”
Sponsor: Autism Speaks Trailblazer Award
Principal Investigator: Madeleine W. Cunningham Co-investigator: Bonnie J. McBride
This is a research study. Research studies involve only individuals who choose to participate. Please take your time to make your decision. Discuss this with your family and friends.
Why Have I Been Asked to Participate In This Study? You and/ or your child are being asked to participate in this study because your child has a diagnosis of autism spectrum disorder (ASD) or a related diagnosis. Your child may display behaviors associated with an obsessive compulsive disorder and/or tics (i.e., uncontrolled movements of the body). Also, your child may be related to someone with these behaviors or your child is a typically developing volunteer and has had uncomplicated streptococcal pharyngitis (e.g. strep throat). Other disorders that may affect the brain are also included in the study such as pediatric autoimmune disorder associated with streptococci (PANDAS), Pediatric Acute Neurologic Syndrome(PANS), Tourette’s Syndrome, other similar related disorders with tic or behavioral OCD symptoms and/or autistic behaviors. This research project is sponsored by Autism Speaks and will be carried out by Madeleine Cunningham, PhD and Bonnie McBride, PhD.
Why is this study being done? This study involves research for the purpose of identifying and characterizing antibodies (a protein in the blood which fights infection or may cause inflammation). We are trying to find out if these antibodies could affect the brain and cause neurological problems, behavioral, emotional or movement problems. This research also involves genetic research.
What procedures are involved in the study? If you volunteer for this study, your child will have blood drawn using a syringe and needle or appropriate blood collection tube equipped with a needle. This procedure is just like giving blood at a doctor’s office or when someone donates blood. No more than 20 ml or 2 teaspoons of blood will be drawn from a child and no more than 500 ml or (equal to a unit of blood as given when donating blood) will be drawn from an adult. The blood will be used to produce antibodies and B cell lines. The gene (part of your DNA) that is producing antibody or the B cell receptor will be identified. Dr. Cunningham may inject a portion of your DNA into a mouse to produce
IRB NUMBER: 3115 IRB APPROVAL DATE: 06/26/2013 IRB EXPIRATION DATE: 05/31/2014
mice which produce your antibody or B cell receptor (transgenic mice). Dr. Cunningham may try to keep your B cells alive indefinitely. This is called a B cell line. If a cell line or transgenic mice are created using your child’s blood, it may be shared with other investigators; however, your identity will not be revealed to them. There is no intent to use your blood or any cell line derived from your blood for commercial purposes or financial gain.
We will keep some of your child’s blood that is left over for future research. This blood will be placed in a tissue bank (a special freezer) together with blood from other individuals who have donated blood for this study. This tissue bank is located at OUHSC. Your blood will be stored indefinitely.
In addition, we would like to ask you some questions about your child and how he or she behaves and how he/she is progressing. You will be asked to complete a questionnaire that will take approximately 20 minutes.
Labeling of Yours or Your Child’s Specimens You and/or child’s blood will not be labeled with your child’s name or other information that would identify them directly. Instead, it will have a unique code that allows for it to be linked to some of your records information at our office. This link means that your specimen can be identified but only indirectly. This helps protect your personal information.
What Sort of Research Will Be Done On My Child’s Tissue? Your child’s blood/tissue may be used by various researchers, including the Principal Investigator, Madeleine W. Cunningham, Bonnie J. McBride, and other researchers here at the University of Oklahoma Health Sciences Center. Your child’s tissue may be used by researchers to learn more about neurological and possibly other diseases. Your child’s blood/tissue may be used for genetic research (to learn about diseases that are passed along in families). Future use of your blood/tissue may involve as yet undiscovered technologies.
How many people will take part in the study? No more than 40 individuals will participate in this study.
What are the benefits of this study? There is no direct benefit to you or your child. Results of the study will help us understand if autism or autistic behaviors can be associated with antibodies against parts of the brain and also if autism and PANDAS/PANS can be present together in the same individual. The results may lead to better ways of diagnosis and treatment of autism spectrum disorders, autistic-like behaviors, movement and tic disorders, obsessive compulsive disorder (OCD), as well as other autoimmune-related neurological and neuropsychiatric diseases.
*********************************************************************************
So here we are....had a great two days at school, followed by an extremely rough day today that included an hour and a half of tantrums, hitting, yelling, pinching, eloping, pulling hair, knocking glasses off of the teacher...
It honestly baffles me how he can be a complete angel one day- chasing his brother up the stairs, yelling "Race ya!",asking to play with Paige, looking me directly in the eyes to ask real questions... and then a raging child the next day. However, that is enough to remind me that inflammation is real-
it may be cruel, but it is real.
And it is a good reminder for me to keep fighting, keep advocating, keep praying, and raise awareness for this cruel, real disorder.
"I Belong"
http://www.youtube.com/watch?v=fU0pK85Xp9g
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