Novel Helmet Design in Patients With Seizures

M

Michael A. Gelfand, MD, PhD

Status

Completed

Conditions

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

Treatments

Device: Hövding inflatable helmet

Study type

Interventional

Funder types

Other

Identifiers

NCT03443388
824620

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

5 participants in 2 patient groups

Part 2: Helmet
Active Comparator group
Description:
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.
Treatment:
Device: Hövding inflatable helmet
Part 2: No Helmet
No Intervention group
Description:
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.

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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