CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
Hövding inflatable helmetdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03443388
NCT03443388N/ACompleted
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A Pilot Study of the Safety of a Novel Helmet Design in Patients With Seizures

Michael A. Gelfand, MD, PhD·interventional·Posted Feb 23, 2018·Updated Jan 9, 2025

In Brief

A clinical study evaluating Hövding inflatable helmet for Drug Resistant Epilepsy and 4 related conditions. Completed, enrolled 9 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDrug Resistant Epilepsy, Drop Seizures, Generalized Tonic Clonic Seizure, Complex Partial Seizure, Fall Due to Seizure
CountriesUnited States
CollaboratorsEpilepsy Foundation

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedFeb 23, 2018
Enrollment StartAug 14, 2017
Primary CompletionDec 15, 2019
Study CompletionMar 20, 2020
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.4 years ago

Interventions

Hövding inflatable helmetdevice

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.