Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care (NCT06346262)
🩺 Plain-English Summary (8th-Grade Level)
This study will be done in two phases. Using stakeholder input (community advisory board (CAB)), the study team will adapt the SMART program to incorporate education and self-management support for use of Rescue Medication (RM) to manage seizure occurrence among Persons With Epilepsy (PWE) who have repetitive seizures. Additional content/support materials, pending input stakeholder might include posters/hand-outs that present information on the use of RM in a way that is engaging and salient to PWE. It is expected that participants will be in Phase 1 for about 3 months and participate in the CAB 2 or 3 times via zoom for 60-90 minutes/meeting. The advisory board will provide input on needed refinement of an adapted version of SMART based on their individual experiences. It is anticipate the total time commitment to be no more than 6 hours over 3 months, spread out over 2-3 meetings with review of materials possible in between meetings. Phase 2: The investigators will use a 6-month prospective trial design to test engagement with and effects of SMART-RM among approximately 35 adult (≥ 18 years) PWE who have repetitive seizures.
Who can join: Review the eligibility criteria below.
Location: Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital — New York, New York
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (2 Sites)
- Icahn School of Medicine at Mount Sinai, Mount Sinai Hospital — New York, New York
- University Hospitals Medical Center — Cleveland, Ohio
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Epilepsy
- Neural Circulatory Control and SUDEP Risk. — Rochester, Minnesota
- BHV-7000 Responsive Neurostimulation System (RNS) Study — New Haven, Connecticut
- RESEARCH EVALUATING VAGAL EXCITATION AND ANATOMICAL LINKS — Stanford, California
- Acute Recording of Stereotyped High-Frequency Oscillations — Rochester, Minnesota
- Neurophysiologically Based Brain State Tracking and Modulation in Focal Epilepsy — Rochester, Minnesota
- Acoustic Stimulation for Seizure Suppression — New York, New York
Explore by condition: All Epilepsy clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.