A major step towards a new approach in clinical trials was recently taken at The University of Texas Health Science Center at Houston (UTHealth), as a group of researchers enrolled patients with acute stroke in a new study being conducted at different hospitals. Participants at Baptist Beaumont Hospital and Memorial Hermann Southwest Hospital will help researchers overcome limitations in the scientific process of testing therapies.
UTHealth researchers used telemedicine, or remote enrollment, to evaluate the compatibility of the candidates who entered one of the two hospitals with acute stroke to participate in the trial. The results of the study entitled “Telemedicine-guided remote enrollment of patients into an acute stroke trial” were recently published in the journal of the American Neurological Association, Annals of Clinical and Translational Neurology.
“One of the main drawbacks of conducting clinical trials for stroke is that we traditionally are limited to patients who arrive at large stroke centers that have the expertise to treat stroke quickly to minimize damage to the brain,” explained the first author of the study and director of the Telemedicine Program, Tzu-Ching Wu, MD, in a press release from UTHealth.
The research team identified 10 candidates at Baptist Beaumont Hospital and Memorial Hermann Southwest Hospital, and enrolled six of them in a randomized, phase III study. During the trials, scientists analyzed both a transcranial Doppler ultrasound and a tissue plasminogen activator (tPA), which are currently the only treatments available for ischemic stroke.
The trial was led by the associate professor of neurology at UTHealth and senior author of the study, Andew Barreto, MD. Patients were identified, screened, enrolled and randomized to either ultrasound or a sham device. “Instead of the patients having to be taken to the mother ship, we brought the study to the patient. The implications are enormous,” Dr. Wu said.
“This opens the doors to clinical trials for everyone and helps move science along. Because of the amount of stroke trials that are conducted, it’s hard to find enough participants. This allows us to widen the pool,” added Dr.Wu, who is also an assistant professor at UTHealth Medical School and at the Memorial Hermann Mischer Neuroscience Institute.
In addition to Tzu-Ching Wu, additional study authors included Amrou Sarraj, MD, Amber Jacobs, Loren Shen, BSN, Hari Indupuru, MBBS, Christy Ankrom and Sean I. Savitz, MD, as well as Donna Biscamp, RN, and Victor Ho of the Beaumont Baptist Hospital and James C. Grotta, MD, from the Memorial Hermann-Texas Medical Center.
Telemedicine is a growing field and includes numerous applications. Last year, the Texas Tech University Health Science Center (TTUHSC) also launched a new telemedicine program to respond to high patient volume, who were waiting for a psychiatrist. The Tele-Psychiatry program uses video chat and is expected to reduce the long waiting lists of the facility.