by
Gus Iversen, Editor in Chief | May 03, 2024
Photo courtesy of National Children's Hospital
Researchers at Children’s National Hospital in Washington, D.C., have launched a pioneering clinical trial to assess the safety and potential therapeutic effects of high-intensity focused ultrasound (HIFU) for treating cerebral palsy symptoms.
The trial is using Insightec’s Exablate Neuro device to noninvasively create lesions in the globus pallidus region of the brain. This area is targeted to manage treatment-resistant secondary dystonia in patients with dyskinetic cerebral palsy. The participant group includes 10 pediatric and young adult individuals, ranging from 8 to 22 years old.
The initial patient treated in January 2024, a 22-year-old who has been under CNH's care since he was four, represents a critical milestone in the study. His treatment follows a history of ineffective muscle hypertonia management through conventional oral medications, highlighting his suitability for the trial.
Over the next two years, researchers will closely monitor various outcomes including changes in the patient's motor skills, pain levels, speech, memory, attention, and overall cognition. According to Dr. Chima Oluigbo, the lead researcher and a pediatric neurosurgeon at CNH, this study aims to develop treatments that alleviate the rigidity and stiffness associated with cerebral palsy, thereby potentially offering new therapeutic avenues for patients without effective treatment options.
“The primary objective of the study is to evaluate the safety of ExAblate Transcranial MRgFUS as a tool for creating bilateral or unilateral lesions in the globus pallidus (GPi) in patients with treatment-refractory secondary dystonia due to dyskinetic cerebral palsy,” Dr. Oluigbo explained. “The secondary purpose is to assess the impact of HIFU pallidotomy on dyskinetic cerebral palsy movement disorder in pediatric and young adult patients.”
The study, sponsored by the Focused Ultrasound Foundation, marks the first global attempt to use this technology for cerebral palsy.
Children's National Hospital, recognized for its commitment to pediatric healthcare innovation, was designated as the Foundation’s first Center of Excellence focused on pediatrics in September 2020. The hospital's focused ultrasound program has evolved since its U.S. debut in treating pediatric osteoid osteoma in 2015, expanding its clinical trials to encompass solid and brain tumors in the pediatric population.
In 2022, Children’s National Hospital successfully performed the first-ever focused ultrasound procedure on a pediatric patient with neurofibromatosis.
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