Novel Helmet Design in Patients With Seizures

Study Overview
=================
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 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.

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

Conditions
-----------------
Drug Resistant Epilepsy, Drop Seizures, Generalized Tonic Clonic Seizure, Complex Partial Seizure, Fall Due to Seizure

Intervention / Treatment
-----------------
* Device: Hövding inflatable helmet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: This is an open-label, randomized, 2-way crossover pilot safety study of the Hövding helmet device in patients with drug resistant epilepsy. Reference therapy is no head-protective device. Part 1 will test helmets on 4 normal controls falling from standing. If the helmet deploys in at least 3 out of 4 falls, we will proceed to Part 2. Part 2 will enroll up to 20 patients with Drug Resistant Epilepsy. Patients will be block randomized to first wear the helmet in their daily lives until helmet deployment or for up to 3 months, or to first not wear a helmet for up to 3 months. Patients in each group will complete self-administered questionnaires. 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 using daily seizure calendar, medical records review, the Rivermead Post Concussive Scale and other qualitative questionnaires.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part 2: Helmet<br>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<br>* 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.<br>|
| No Intervention: Part 2: No Helmet<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
helmet, device, head injury from seizures, seizures resulting in fall, helmet for seizures, novel helmet design, inflatable helmet, Hovding Inc