Novel Helmet Design in Patients With Seizures

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.

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.