The onset of stroke often takes people by surprise. However, those who have already suffered from ischemic stroke have the opportunity to utilize stroke recovery and prevention strategies to avoid another stroke, which could prove to be fatal. Thanks to a new study led by University of Texas Health Science Center at Houston (UTHealth) researchers, a newly-developed, hands-free ultrasound device, when used in tandem with a clot-busting drug, may offer safe, improved preventative treatment for ischemic stroke patients.
The results of the recent phase II pilot study, which were published in the American Heart Association’s journal Stroke, outline how this new device, a technology developed at UTHealth and licensed to Cerevast Therapeutics, Inc., employs a novel treatment method wherein the CLOTBUST ER device ” . . .is placed on the stroke patient’s head and delivers ultrasound to enhance the effectiveness of the clot-busting drug tissue plasminogen activator (tPA), according to a recent press release. While other hand-held ultrasound probes for stroke recovery therapy are designed to target a speficic region in the brain with a blood clot, the hands-free design of the CLOTBUST ER instead uses 18 separate probes, which re used to penetrate deeply into the brain so that it can break up the blood clots that often lead to the most severe strokes.
The UTHealth study, which is the first study of its kind, enrolled 20 moderately severe ischemic stroke patients (12 men and eight women, average age 63 years), all of which received intravenous tPA (a clot-busting drug) up to 4.5 hours after symptoms occurred and two hours exposure to 2-MHz pulsed wave transcranial ultrasound. From the data collected from the study, researchers found that that 13 (or 65 percent) patients either returned home or to stroke recovery rehabilitation 90 days after the combination treatment of the tPA along with the CLOTBUST ER. After three months, the study found that five of the 20 patients had no disability from the stroke and one had slight disability.
Principal investigator of the study is James C. Grotta, M.D., professor and chair of the Department of Neurology at the UTHealth Medical School, the Roy M. & Phyllis Gough Huffington Distinguished Chair and co-director of the Mischer Neuroscience Institute at Memorial Hermann-Texas Medical Center. In addition, lead author of the study, Andrew D. Barreto, M.D., assistant professor of neurology in the Stroke Program at the UTHealth Medical School, stated: “Our goal is to open up more arteries in the brain and help stroke patients recover,”adding that, “This technology would have a significant impact on patients, families and society if we could improve outcomes by another 10 percent or more by adding ultrasound to patients who’ve already received tPA.”
Cerevast Therapeutics’ study for the CLOTBUST ER extends beyond UTHealth, however. The company has recently launched an 830-patient international, randomized efficacy study of the ultrasound approach combined with the clot buster in ischemic stroke. UTHealth’s Dr. Barreto is serving as the North American principal investigator for that Phase III study, which is entitled, “Combined Lysis of Thrombus with Ultrasound and Systemic Tissue Plasminogen Activator (tPA) for Emergent Revascularization in Acute Ischemic Stroke (CLOTBUST-ER).” In Texas, patients are being recruited from Memorial Hermann-Texas Medical Center, Memorial Hermann Southwest Hospital and Baptist Beaumont Hospital.
Looking for more information about the CLOTBUST ER clinical study? Click on the banner ad below to go to the CLOTBUST ER clinical trials information page at clinicaltrials.gov:
The study was conducted at UTHealth and the University of Alabama-Birmingham with funding from the National Institutes of Health (NIH) including the National Institute of Neurological Disorders and Stroke (P50NS044227, 1K23NS02229-01, 1P50NS044277), an NIH training grant (T32NS07412) and the National Center for Research Resources (UL1RR024148).
UTHealth co-authors are Nicole Gonzales, M.D.; Sean I. Savitz, M.D.; Andrew Bursaw, M.D.; Preeti Sahota, M.D.; Renganayaki Pandurengan, Ph.D.; Mohammad Rahbar, Ph.D.; Loren Shen, B.S.N.; Manouchehr Ardjomand- Hessabi, M.D.; Hari Indupuru, M.B.B.S.; and Hui Peng, Ph.D. Other co-authors are Andrei Alexandrov, M.D.; April Sisson, R.N.; and Kristian Barlinn, M.D.
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