Novel Helmet Design in Patients With Seizures
Condition: Drug Resistant Epilepsy; Drop Seizures; Generalized Tonic Clonic Seizure; Complex Partial Seizure; Fall Due to Seizure
MeSH terms: Seizures; Drug Resistant Epilepsy
Study type: Interventional

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.
    

Intervention name(s): Hövding inflatable helmet
Intervention type(s): Device
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention 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)
Primary purpose: Prevention
Keywords: head injury from seizures; seizures resulting in fall; helmet for seizures; novel helmet design; inflatable helmet; Hovding Inc; helmet; device