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Completed

NCT Number: NCT03443388

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.

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Key information

Conditions

Drug Resistant Epilepsy Brain Diseases Central Nervous System Diseases Complex Partial Seizure Consciousness Disorders Drop Seizures Epilepsy Epilepsy, Generalized Epilepsy, Tonic-Clonic Fall Due to Seizure Generalized Tonic Clonic Seizure Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms Syncope Unconsciousness

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Treatment and study plan

Hövding inflatable helmet

Device

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.

Primary outcomes

  1. Part 1: Number of Successful Deployments

    Time frame: 1 day

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

  2. Part 2: Helmet Deployment Questionnaire

    Time frame: 6 months

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

Secondary outcomes

  1. Rivermead Post Concussive Scale

    Time frame: 6 months

    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.

  2. Seizure Questionnaire

    Time frame: 6 months

    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.

  3. Injury-related Medical Record Review

    Time frame: 6 months

    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.

  4. Helmet Deployment Questionnaire (Seizure/Not Seizure)

    Time frame: 6 months

    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.

Sponsors and collaborators

Lead sponsor

Michael A. Gelfand, MD, PhD

Other

Collaborators

  • Epilepsy Foundation

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Feb 23, 2018
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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