Novel Helmet Design in Patients With Seizures

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

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 Overview

• Status: Completed
• Conditions: Generalized Tonic Clonic Seizure; Drug Resistant Epilepsy; Drop Seizures; Complex Partial Seizure; Fall Due to Seizure
• Intervention / Treatment: Device: Hövding inflatable helmet

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Part 1:

1. Age 18-60 at the time of enrollment.
2. Have neck circumference between 34 and 42 cm.
3. Can understand and provide written informed consent.
4. Must be competent to follow all study procedures.
5. Able to read, speak, and understand English.

Part 2:

1. 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).
2. Has a seizure frequency of at least once per 2 months.
3. Be between ages 18-65 at the time of enrollment.
4. Have neck circumference between 34 and 42 cm
5. Must live in a home with electrical power supply.
6. 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.
7. Can understand and sign written informed consent.
8. Must be competent to follow all study procedures.
9. Able to read, speak, and understand English.

Exclusion Criteria:

Part 1:

1. Subject is currently pregnant

Part 2:

1. Patient already wears a helmet for seizure safety.
2. Subject is pregnant, planning to become pregnant during the study, or is unwilling to use an appropriate form of birth control during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Part 2: Helmet; After a screening period, 10 patients with drug resistant epilepsy will first be assigned to wear one Hövding inflatable helmet in their daily lives. Subjects will fill out questionnaires about their seizures, injuries, and the circumstances of inflation when it occurs. After experiencing a seizure resulting in a fall or any helmet deployment, patients will crossover to the "no helmet" group. If no seizure resulting in fall occurs in 3 months, participation will end.	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.
No Intervention: Part 2: No Helmet; After a screening period, 10 subjects with drug resistant epilepsy will first be assigned to not wear an inflatable helmet. Subjects will fill out questionnaires about their seizures and injuries. After approximately 3 months, patients will crossover to the "helmet" group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Number of times the helmet deploys during staged fall	Will proceed to Part 2 if helmet deployment in at least 3 out of 4 falls	1 day
Part 2: Helmet Deployment Questionnaire (helmet/no helmet)	Differences in Helmet Deployment Questionnaire responses will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rivermead Post Concussive Scale	Differences in head injury symptoms as reported using the Rivermead Post Concussive Scale will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure, and also between subjects following a seizure in which the helmet deployed, and seizures in which the helmet was either not being worn or did not deploy.	6 months
Seizure Questionnaire	Differences in Seizure Questionnaire responses detailing circumstances of seizure and any injuries sustained will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure, and also between subjects following a seizure in which the helmet deployed, and seizures in which the helmet was either not being worn or did not deploy.	6 months
Injury-related Medical Record Review	Differences in injuries resulting from a seizure per injury-related medical record review will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure, and also between subjects following a seizure in which the helmet deployed, and seizures in which the helmet was either not being worn or did not deploy.	6 months
Helmet Deployment Questionnaire (seizure/not seizure)	Differences in helmet deployment questionnaire responses describing events of helmet deployment during seizures resulting in falls will be compared with responses describing helmet deployment (per day of use) not associated with seizure.	6 months

Collaborators and Investigators

• Sponsor: Michael A. Gelfand, MD, PhD
• Collaborators: Epilepsy Foundation
• Investigators: Principal Investigator: Michael Gelfand, MD, PhD, University of Pennsylvania

Publications and helpful links

General Publications

• King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811.

Helpful Links

• Hovding - Airbag for Cyclists

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2017
• Primary Completion (Actual): December 15, 2019
• Study Completion (Actual): March 20, 2020

Study Registration Dates

• First Submitted: February 7, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (Actual): February 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2020
• Last Update Submitted That Met QC Criteria: April 17, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: device; head injury from seizures; seizures resulting in fall; helmet for seizures; novel helmet design; inflatable helmet; Hovding Inc; helmet
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Drug Resistant Epilepsy
• Other Study ID Numbers: 824620

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Hövding Inc. may receive the used helmets and the information about how they were deployed. All information shared will be deidentified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No