About three million people in the U.S have epilepsy with Mesial Temporal Lobe Epilepsy (MTLE) being the most common form of partial or localization related epilepsy. It is estimated that at least one-third of MTLE patients become drug resistant and continue to have seizures regardless of the number or type of anti-epileptic drugs used.
Medtronic plc www.medtronic.com headquartered in Dublin announced that the first procedure using the Visualase ™ MRI-Guided Laser Ablation System has been performed in the SLATE clinical trial at Mayo Clinic.
The Visualase system was cleared by the FDA to necrotize or coagulate soft tissue in neurosurgery and other surgical specialties. However, Visualase is not cleared or approved for the treatment of epilepsy and using Visualase to treat epilepsy is investigational for use only in the U.S.
During the clinical trial, approximately 120 adult patients with drug-resistant MTLE will be treated at selected epilepsy centers in the U.S. that includes Emory University, Mayo Clinic, Northwell Health, Thomas Jefferson University Hospital, and the University of Miami Health System.
After the Visualase procedure, subjects will be followed for 12 months and evaluated on the number of seizures, quality of life, adverse events, and neuropsychological outcomes. The clinical trial will use the data collected to enable the comprehensive evaluation of the risks and benefits of the device to ensure that treating physicians are well-informed about its use.
For information on the SLATE trial sponsored by Medtronic Navigation, Inc. go to https://clinicaltrials.gov/ct/show/NCT02844465 with the identifier (NCT0284465). The trial due to be completed October 2020. Contact is Guy Alvarez, PhD at rs.slatestudy@medtronic.com for more details.
Another project underway is helping patients with epilepsy learn how to manage their own unique symptoms. They are now able to use a new tablet computer to seek individualized information through a research project at the University of Illinois at Chicago (UIC) www.uic.edu.
UIC is working with the Epilepsy Foundation www.epilepsy.com to create a way for patients with epilepsy and their caregivers to self-manage epilepsy. To accomplish this goal, the Personalized Internet Assisted Underserved Self-management for Epilepsy (PAUSE) a tablet-based tool is customized for each patient to help them stay healthy and reduce the need for emergency services.
By using a tablet, physicians or nurses are able to design a personalized program that can run at a customizable pace with a trained educator or nurse online, it is possible to advise patients not only on medication management but also how to avoid seizure triggers and discuss issues around driving or other topics.
PAUSE is one of five UIC projects supported by the Illinois Prevention Research Center (IPRC) a part of the UIC Institute for Health Research and Policy www.ihrp.uic.edu. The IPRC is funded by a grant from CDC www.cdc.gov to conduct innovative public health prevention research.
The PAUSE study is also a part of the Managing Epilepsy Well Network https://managingepilepsywell.org which is coordinated by the Health Prevention Research Center at Dartmouth College http://tdi.dartmouth.edu/research/intervention/prevention-research.