printable versionStudy of seizure treatments demands split-second decisions
BY DIANE ROGERS
James Quinn
In the Web site video, a young boy lies on the grass, shaking violently.
His seizure could be the result of epilepsy, injury, drugs, a stroke or tumor or a number of other neurological factors. But whatever the cause, the faster he is treated, the better. "You want to stop a seizure as soon as you can," said James Quinn, MD, associate professor and research director in emergency medicine at the medical school. "Paramedics now stop them with medications in the field, but there's a big variation in practice about what medications to use."
The Web site video is part of an outreach effort to inform the community about a study that Quinn and colleagues throughout the country are about to launch that aims to determine which of two seizure treatments is more effective. What's unusual about their effort is that the patients who participate in the study won't be able to give informed consent at the time; so Quinn and his team want to give the community the opportunity to learn more about the study now and, if they choose, to opt out of possible participation.
Quinn, who also treats patients in the emergency room at Stanford Hospital & Clinics, will be heading up the Stanford portion of the planned national survey to study how best to treat prolonged seizures known as status epilepticus. The three-year study, known as Rapid Anticonvulsant Medication Prior to Arrival Trial or RAMPART, is scheduled to start in early 2009.
This trial is part of the Neurological Emergencies Treatment Trial Network, which consists of 17 academic medical centers, including Stanford. The RAMPART study will determine whether anti-seizure medicine works better and more quickly when it is delivered intravenously through an I.V., or when it is given as a shot in a muscle.
"The I.V. may go faster in the bloodstream to the brain, but it can take time to start an I.V. if someone is having a grand mal seizure," Quinn said. "That delay might make the other approach, where the medicine is absorbed quickly into the muscle, actually faster in getting to the brain."
In the RAMPART clinical trial, patients will be randomly assigned to treatment groups where they would either receive lorazepam (Ativan) intravenously or be injected with midazolam (Verced) with a new fast-release syringe. Both drugs have similar effects in stopping seizures, Quinn said, but there have been no head-to-head comparisons to check for any differences between them.
What's unusual about the planned phase-3 clinical trial is that the patients will be unconscious when they are enrolled by paramedics. Unlike participants in other research studies, patients experiencing seizures cannot give their permission. Instead, they will be treated under federal rules that provide for an exception from informed consent. This exception is allowed only in studies of life-threatening emergencies.
"It's really the only way to do emergency medicine research," Quinn said.
He and co-investigators Christine Wijman, MD, associate professor of neurology and neurological sciences, and Ronald Torres, MD, clinical assistant professor of neurosurgery, are nevertheless eager to explain how the study will work to members of the public who are served by 19 community hospitals, including Stanford Hospital, in Santa Clara and San Mateo counties. Quinn said some 50 patients from the area ultimately might participate in the local portion of the trial, which is planned to involve more than 800 patients nationwide.
"We want to understand people's concerns about the study," Quinn said. "And people who don't want to participate can opt out." They can do that by wearing red bracelets that will be provided, at no cost, by the researchers. Those who opt out of the study and experience a seizure would receive whatever treatment was the standard protocol—one of the two options in the study—but their outcomes would not be tracked.
Area residents can pose questions by calling study coordinator Stephanie Casal, RN, at 721-2645. They also can go to the study Web site at https://med.stanford.edu/survey/rampart to watch a video and fill out a quick survey.
The RAMPART study is being funded by the National Institutes of Health.