The first clinical trial of the country for the rehabilitation of victims of childhood stroke

Stroke is a devastating event often badociated with people over 65 years old. But a large number of infants also have a stroke.

Now, in the first multi-center pediatric stroke recovery trial in the United States, researchers and clinicians from 12 sites across the United States will evaluate an innovative therapeutic approach to help infants aged 8 to 24 months .

The Phase III clinical trial, called I-ACQUIRE, will examine the effectiveness of a pediatric treatment aimed at improving upper limb skills, overall motor development and cognition of 240 children in the country having suffered a stroke while they were less than four weeks old.

Sharon Landesman Ramey, professor and researcher emeritus at the VRC's Fralin Biomedical Research Institute, and Warren Lo, pediatric neurologist at the Children's Nationwide Hospital and clinical professor of pediatrics and neurology at the College of Medicine of the United States. Ohio State University, are the principal investigators of the $ 13.5 million grant over five years from the National Institute of Neurological Disorders and Stroke at the National Institutes of Health.

I-ACQUIRE therapy will be tested in children at a daily dose of three hours and six hours for four weeks to determine whether the more intensive dose produces better results or whether the three-hour daily sessions are equally effective.

The intensive rehabilitation protocol is based on more than two decades of pediatric rehabilitation research led by Landesman Ramey and Stephanie DeLuca, co-directors of the Fralin Biomedical Research Institute neuromotility research clinic.

"It's a revelation when people learn that babies, like adults, are at a very high risk of stroke," said Landesman Ramey. "About half of these infants will not suffer from permanent impairment, but for others, strokes are a serious event that can lead to serious neuromotor problems throughout life." Stroke's impact on the child and his family, it's amazing that there is little or no scientific evidence to support the rehabilitation approaches currently used. "

The results of the trial could transform the clinical rehabilitation of more than 3,000 newly diagnosed infants each year in the United States who have a stroke before birth or in their first month of life.

Perinatal stroke results from blockage of a cerebral artery of the brain in children before they are born or during the first month of their life. Damage caused by stroke in the brain usually causes muscle weakness, loss of motor control and paralysis on one side of the body. It can also affect communication skills and other areas of development.

"We are honored to bring together expertise in pediatric neurology, psychology, rehabilitation and neuroimaging for this unprecedented clinical trial," said Lo. "Perinatal stroke is a life-altering neurological disease and offers many opportunities to enhance early development and independence so that these children can reach their full potential."

DeLuca and Landesman Ramey initially developed and tested a new form of pediatric motion therapy, adapted from an adult treatment called stress-induced motion therapy, when they were working together at the University of California. Alabama in Birmingham (UAB).

Key features include a lightweight cast iron specially designed for the child's unaltered arm and hand, which requires infants to increase their efforts to use the impaired side by stroke. The casting always takes place in conjunction with an intensive rehabilitation protocol administered several hours a day, five days a week, for four consecutive weeks.

Unlike adults, children do not develop the use of their upper limbs. Thus, after a stroke, they do not "recover" lost skills. instead, they acquire new age-appropriate skills that the therapist brings through reinforcement and a process called skills training.

"Three or six hours of therapy may seem shocking, but as parents and therapists will tell you, young kids love to play and interact with people, food, objects and toys. This is what the therapy feels for the child. there are times of frustration when the therapist challenges the child, "said Landesman Ramey." For babies, effective therapy is a form of guided play. They learn to use their impaired side in all kinds of activities: eating, pulling to sit or stand, crawling or walking, shaking and hugging. "

The I-ACQUIRE trial is part of a national stroke research network, called StrokeNet, which brings together two national and 29 regional coordination centers, funded by the National Institute of Disorders. neurological and stroke.

The Fralin Biomedical Research Institute, a Virginia Tech University-level research institute, will oversee the I-ACQUIRE Phase III trial, which includes funding for the program's management work in Roanoke as well as the under-allocation of 39, a national coordination center at the university. of Cincinnati, a national evaluation center at Ohio State University, a data management and statistics center at the University of Medicine at South Carolina, and a neuroimaging center at Stanford University.

DeLuca, along with Craig Ramey, professor and researcher emeritus of the Fralin Biomedical Research Institute, and a team of I-ACQUIRE master therapists in Roanoke, Va., Will train field therapists directly in the rehabilitation technique I- Acquire and monitor the implementation of treatment in the 12 locations where clinical treatment will take place.

In addition to training field therapists, I-Acquire experts from the Fralin Biomedical Research Institute will be treating Roanoke's children during the course of a new parent-home program.

"We are very pleased to participate and play a leading role in this very important clinical trial for children," said Michael Friedlander, Executive Director of the Fralin Biomedical Research Institute and Vice President of Technology and Health Sciences at Virginia Tech. "Dr. Ramey and Dr. DeLuca are true pioneers and innovators in the development and implementation of this important therapeutic intervention that they will bring to the entire country as part of a rigorously designed and controlled study. of major biomedical research on neuroscience, brain plasticity, development and neuroimaging, we are particularly excited to see the translation and implementation of fundamental scientific principles from the laboratory to the clinic to improve the lives of children and families. "

The I-ACQUIRE trial will pay particular attention to training and standardization.

"Babies nap whenever they want, get tough when they want, get sick, and need help at unpredictable times," said Joseph Broderick, principal investigator of the StrokeNet National Coordination Center at the University. of Cincinnati. "These are all events that will affect the delivery of home treatment, however, therapists will record the amount of treatment they are given in order to measure it.This is essential for testing and for future generalization in the home. practical, if the test is positive. "

Broderick heads the Gardner Institute of Neuroscience at the University of Cincinnati, but he first learned of the particular difficulties families face when a child suffers a stroke after a cerebral infarction before his or her month and that he then received the treatment evaluated as part of the clinical trial.

"Parents desperately need some intervention to help their child and three or six hours of home therapy five days a week would be extremely welcome," Broderick said. "The presence of a therapist at home is not seen as a burden, but as a huge help and opportunity."

Therapy is not covered by health insurance, but if it turns out effective on all research sites, it could be ensured in the future. "It's a well-designed study that targets a specific age group," Broderick said. "We'll see if it works."

Landesman Ramey said that more than 90% of patients had benefited in clinical experiences with more than 30 infants who received this intensive form of ACQUIRE treatment by the age of 2 years. "In this essay, we focus on the total number of children, fascinated by the interaction of motor development with intelligence and cognition," said Landesman Ramey. "In addition to a better movement, we found that children improved a lot in terms of language and cognition and that their social and emotional development improved. waits all his life with a child suffering from stroke, these multi-faceted changes are perhaps the most profound and consistent transformation. "

In addition to the coordination centers, children will receive therapy at clinical sites in Ann Arbor, Michigan; Atlanta, Georgia; Baltimore, Maryland; Boston, Mbadachusetts; Chicago, Illinois; Cincinnati, Ohio; Columbus, Ohio; Houston, Texas; New Haven, Connecticut; Philadelphia, Pennsylvania; Roanoke, Virginia; and San Diego, California.

Registration for the study will begin in the summer of 2019. Parents and clinicians wishing to participate in the clinical study can find out more by contacting Ramey at the Fralin Biomedical Research Institute or by email. consulting the website clinicaltrials.gov later in April.

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