Novel Helmet Design in Patients With Seizures

Drug Resistant Epilepsy Clinical Trial

Official title: A Pilot Study of the Safety of a Novel Helmet Design in Patients With Seizures

Status Completed

Clinical Trial 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 qualitative patient reporting.

Clinical Trial 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 resistant epilepsy who do not use existing head-protective devices will be enrolled and assigned to first enter "helmet" or "no helmet" groups. When assigned to the "helmet" group, patients will wear the helmet until deployment during a seizure or up to 3 months. Subjects will complete questionnaires about their seizures including any injuries sustained, post concussive symptom questionnaire, and the circumstances of inflation. Patients will return to site after helmet deployment. While assigned to the "no helmet" group, patients will complete the same questionnaires, except those relating to helmet inflation. We will compare circumstances, injuries, and post concussive scales in seizures resulting in falls occurring while the helmet was worn versus seizures resulting in falls occurring while the helmet was not being worn. ;

Related Conditions & MeSH terms

• Complex Partial Seizure
• Drop Seizures
• Drug Resistant Epilepsy
• Fall Due to Seizure
• Generalized Tonic Clonic Seizure
• Seizures

• NCT number: NCT03443388
• Study type: Interventional
• Source: University of Pennsylvania
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Completion date: March 20, 2020