Novel Helmet Design in Patients With Seizures

Michael A. Gelfand, MD, PhD9 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

Part 1: Number of Successful Deployments

3 out of 4 successful deployments was set as a criteria to allow advancement to part 2.

Time frame: 1 day

Part 2: Helmet Deployment Questionnaire

Differences in Helmet Deployment Questionnaire responses will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure.

Time frame: 6 months

Secondary Outcomes

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. The scale for each item of this survey: 0 = not experienced at all 1 = no more of a problem 2 = a mild problem 3 = a moderate problem 4 = a severe problem. Each item was assessed as "compared with before the accident, do you now (i.e., over the last 24 hours) suffer from:" or "Are you experiencing any other difficulties?" with a write in option with the same scale. A lower score on each item is better, indicating lesser symptom severity compared to prior to falling with or without the helmet. The score for each item is summed to obtain each patient's total, indicative of total symptom severity. Total range from 0 - 72.

Time frame: 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.

Time frame: 6 months

Data from ClinicalTrials.gov

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