Clinical trial to assess rehabilitation treatment for infants and toddlers after stroke
In the first of its kind for the tiniest stroke survivors, researchers at UTHealth will lead a stroke rehabilitation clinical trial in the state of Texas through a multi-institutional NIH StrokeNet initiative.
Children who have suffered a perinatal arterial ischemic stroke (PAIS) that has left them with weakness on one side of their body may be eligible for enrollment in Phase III of the clinical trial, I-ACQUIRE, by researchers from the UTHealth Institute for Stroke and Cerebrovascular Disease.
NIH StrokeNet was created by the National Institutes of Health (NIH) as a network of centers that conduct multi-site clinical trials to advance acute stroke treatment, stroke prevention, treatment, and recovery. UTHealth is overseeing the largest of the 27 coordinating centers established throughout the country. McGovern Medical School Department of Pediatrics, UTHealth Neurosciences, Children’s Memorial Hermann Hospital, Memorial Hermann TIRR and Texas Children’s Hospital, are part of the collaborative StrokeNet team for the study.
“Pediatric ischemic stroke is understudied, so we are excited to work with all of our partners to examine an intense therapy for infants and toddlers with stroke,” said Sean I. Savitz, principal investigator for the UTHealth Regional Coordinating Center in StrokeNet. Savitz is the Frank M. Yatsu, M.D. Chair in Neurology at McGovern Medical School at UTHealth, director of the Institute for Stroke and Cerebrovascular Disease, and director of the Stroke Program for UTHealth Neurosciences and Memorial Hermann Health System.
Pediatric arterial (PAS) is a condition in which infants experience a stroke in utero or in the first 28 days after birth. According to the NIH, it occurs in about 1 of 1,150 live births in the U.S. It is often caused by a blockage in a blood vessel in the brain, and can lead to lifelong impairments, especially if left untreated. For newborns, common signs of a stroke include seizures, brain damage that is assessed via imaging, and/or a decrease in muscle movement.
I-ACQUIRE will use constraint-induced movement therapy on a child’s “good” arm encourage them to use their weaker arm. Treatment will occur in the home with trained therapists using techniques to shape upper extremity skills through fun games, and self-help activities.
I-ACQUIRE will be used to treat children in two levels of therapy: three hours/day (moderate dose), six hours/day (high dose) compared to the usual and customary treatment.
“Because the brain is still developing, this type of therapy can help patients to regain better control and strength on the weaker side,” said Nivedita Thakur, MD, principle investigator of the study and assistant professor in the Department of Pediatrics at McGovern Medical School at UTHealth and a member of the stroke institute. “There is evidence of altered brain structure and function due to neuroplasticity of the developing brain.”
Sharon Landesman Ramey, PhD, a professor and distinguished research scholar at Fralin Biomedical Research Institute at Virginia Tech; and Warren Lo, MD, a pediatric neurologist at Nationwide Children’s Hospital and a clinical professor of pediatrics and neurology at The Ohio State University College of Medicine, are principal investigators for the five-year study, funded with a $13.5 million grant from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health – 1U01NS106655-01A1.
For more information on enrollment for I-ACQUIRE, call Dory Parker, research coordinator, at 713-500-7085 or email Dorothea.M.Parker@uth.tmc.edu.
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