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 40 patients with drug resistant epilepsy who do not use existing head-protective devices will be enrolled and assigned to “helmet” or “no helmet” groups. Patients will be assigned to wear the helmet until deployment during a seizure, up to 6 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. We will compare circumstances, injuries, and post concussive scales in seizures where the helmet deploys to seizures, if present where the helmet did not deploy.
Recruitment status: recruiting
First posted: February 23, 2018
Actual start date: August 14, 2017
Estimated study completion date: August 2018
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.
- Not have a practice of wearing a static helmet for protection during seizures prior to the study
- 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:
- Subject currently has an intracranial device or vagus nerve stimulator.
- 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.