Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs

Launched by BRAIN SENTINEL · Nov 12, 2018

Keywords

ClinConnect Summary

This clinical trial is exploring how a special device called the SPEAC® System can help doctors make better treatment decisions for veterans who have seizures that are difficult to control with medications. The study focuses on veterans who have motor seizures involving their arms or hands and who have not found relief after trying at least three different anti-epileptic drugs. The goal is to see if this new monitoring system, which tracks and alerts caregivers about seizures, can improve care for these patients.

To be eligible for the trial, participants must be veterans aged 22 to 99 who experience seizures at least once a month and are willing to use the monitoring system for several months. They must also be able to understand and agree to the study requirements. Participants can expect to wear the device for about 30 hours each week, and they'll be helping researchers understand how this technology might improve their treatment options. It's important to note that certain individuals, such as those who are pregnant or have specific allergies, may not be able to participate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject is a veteran with a reported history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization.
• • 2. Subjects suspected of experiencing one or more spells per month.
• • 3. Subjects has failed at least 3 anti-epileptic drugs (single or combination).
• • 4. Male or Female between the ages 22 to 99.
• • 5. If female and of childbearing potential, subject must agree to not become pregnant during the trial.
• • 6. Can understand and sign written informed consent or will have a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
• • 7. Subject or Primary Caregiver must be competent to follow all study procedures.
• • 8. Subject must be willing to use the Seizure Monitoring and Alerting System for a prolonged period (up to five months), for a minimum of 30 hours/ week.
• Exclusion Criteria:
• • 1. The subject cannot be pregnant, or nursing.
• • 2. The subject cannot be sensitive or allergic to adhesives or tapes.
• • 3. The subject may not be enrolled in another Clinical Trial.
• • 4. The subject is homeless or in a home without a power supply.