Novel Helmet Design in Patients With Seizures

Drug Resistant Epilepsy Clinical Trial

Official title:

A Pilot Study of the Safety of a Novel Helmet Design in Patients With Seizures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443388
• Other study ID #: 824620
• Status: Completed
• Phase: N/A
• Start date: August 14, 2017
• Est. completion date: March 20, 2020

Study information

• Verified date: April 2020
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: March 20, 2020
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Hövding inflatable helmet
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.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Michael A. Gelfand, MD, PhD	Epilepsy Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1: Number of times the helmet deploys during staged fall	Will proceed to Part 2 if helmet deployment in at least 3 out of 4 falls	1 day
Primary	Part 2: Helmet Deployment Questionnaire (helmet/no helmet)	Differences in Helmet Deployment Questionnaire responses will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure.	6 months
Secondary	Rivermead Post Concussive Scale	Differences in head injury symptoms as reported using the Rivermead Post Concussive Scale will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure, and also between subjects following a seizure in which the helmet deployed, and seizures in which the helmet was either not being worn or did not deploy.	6 months
Secondary	Seizure Questionnaire	Differences in Seizure Questionnaire responses detailing circumstances of seizure and any injuries sustained will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure, and also between subjects following a seizure in which the helmet deployed, and seizures in which the helmet was either not being worn or did not deploy.	6 months
Secondary	Injury-related Medical Record Review	Differences in injuries resulting from a seizure per injury-related medical record review will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure, and also between subjects following a seizure in which the helmet deployed, and seizures in which the helmet was either not being worn or did not deploy.	6 months
Secondary	Helmet Deployment Questionnaire (seizure/not seizure)	Differences in helmet deployment questionnaire responses describing events of helmet deployment during seizures resulting in falls will be compared with responses describing helmet deployment (per day of use) not associated with seizure.	6 months

External Links

•   Hovding - Airbag for Cyclists