NCT03443388

Novel Helmet Design in Patients With Seizures

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Michael A. Gelfand, MD, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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 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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Hövding inflatable helmet	The Hövding inflatable helmet is designed for cyclists as a collar with a deployable airbag that inflates when a sensor detects rapid changes in acceleration. The inflated helmet wraps the back and sides of the user's head in inflated nylon fabric which then slowly deflates after deploying.

Timeline

• Start date: 2017-08-14
• Primary completion: 2019-12-15
• Completion: 2020-03-20
• First posted: 2018-02-23
• Last updated: 2025-01-09
• Results posted: 2025-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study