Clinical trial NCT03443388: Novel Helmet Design in Patients With Seizures
Official title: A Pilot Study of the Safety of a Novel Helmet Design in Patients With Seizures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Resistant Epilepsy
Drop Seizures
Generalized Tonic Clonic Seizure
Complex Partial Seizure
Fall Due to Seizure
Keywords: head injury from seizures
seizures resulting in fall
helmet for seizures
novel helmet design
inflatable helmet
Hovding Inc
helmet
device
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Epilepsy Foundation
First posted: 2018-02-23
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: PREVENTION

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Part 1: Number of Successful Deployments
timeFrame: 1 day
measure: Part 2: Helmet Deployment Questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Rivermead Post Concussive Scale
timeFrame: 6 months
measure: Seizure Questionnaire
timeFrame: 6 months
measure: Injury-related Medical Record Review
timeFrame: 6 months
measure: Helmet Deployment Questionnaire (Seizure/Not Seizure)
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michael Gelfand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811.