Status:
COMPLETED
Novel Helmet Design in Patients With Seizures
Lead Sponsor:
Michael A. Gelfand, MD, PhD
Collaborating Sponsors:
Epilepsy Foundation
Conditions:
Drug Resistant Epilepsy
Drop Seizures
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
This is a two-part study that aims to determine the reliability and safety of the use of the Hövding inflatable helmet in seizures, as evidenced by the deployment of the helmet during seizures, and qu...
Detailed Description
Part 1: 4 healthy volunteers will fall from a standing position onto a padded surface to evaluate for consistent helmet deployment from a standing position. Part 2: up to 20 patients with drug resista...
Eligibility Criteria
Inclusion
- Part 1:
- Age 18-60 at the time of enrollment.
- Have neck circumference between 34 and 42 cm.
- Can understand and provide written informed consent.
- Must be competent to follow all study procedures.
- Able to read, speak, and understand English.
- Part 2:
- Have at least one seizure every 6 months that might result in a fall (Generalized Tonic Clonic Seizure, Atonic Seizure, and/or Complex Partial Seizure resulting in a fall).
- Has a seizure frequency of at least once per 2 months.
- Be between ages 18-65 at the time of enrollment.
- Have neck circumference between 34 and 42 cm
- Must live in a home with electrical power supply.
- If female and of childbearing potential, has negative pregnancy test at the beginning of the study and willing to use appropriate birth control for the duration of the study.
- Can understand and sign written informed consent.
- Must be competent to follow all study procedures.
- Able to read, speak, and understand English.
Exclusion
- Part 1:
- 1\. Subject is currently pregnant
- Part 2:
- Patient already wears a helmet for seizure safety.
- Subject is pregnant, planning to become pregnant during the study, or is unwilling to use an appropriate form of birth control during the study.
Key Trial Info
Start Date :
August 14 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2020
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT03443388
Start Date
August 14 2017
End Date
March 20 2020
Last Update
January 9 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104