Back to resultsNovel Helmet Design in Patients With Seizures
Primary Purpose
Drug Resistant Epilepsy, Drop Seizures, Generalized Tonic Clonic Seizure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hövding inflatable helmet
Sponsored by
About this trial
This is an interventional prevention trial for Drug Resistant Epilepsy focused on measuring head injury from seizures, seizures resulting in fall, helmet for seizures, novel helmet design, inflatable helmet, Hovding Inc, helmet, device
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.
- 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.
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Part 2: Helmet
Part 2: No Helmet
Arm 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.
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
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.
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.
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.
Full Information
NCT ID
NCT03443388
First Posted
February 7, 2018
Last Updated
April 17, 2020
Sponsor
Michael A. Gelfand, MD, PhD
Collaborators
Epilepsy Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03443388
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
August 14, 2017 (Actual)
Primary Completion Date
December 15, 2019 (Actual)
Study Completion Date
March 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael A. Gelfand, MD, PhD
Collaborators
Epilepsy Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part 2: Helmet
Arm Type
Active Comparator
Arm 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.
Arm Title
Part 2: No Helmet
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
Hövding inflatable helmet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Part 1: Number of times the helmet deploys during staged fall
Description
Will proceed to Part 2 if helmet deployment in at least 3 out of 4 falls
Time Frame
1 day
Title
Part 2: Helmet Deployment Questionnaire (helmet/no helmet)
Description
Differences in Helmet Deployment Questionnaire responses will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rivermead Post Concussive Scale
Description
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.
Time Frame
6 months
Title
Seizure Questionnaire
Description
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.
Time Frame
6 months
Title
Injury-related Medical Record Review
Description
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.
Time Frame
6 months
Title
Helmet Deployment Questionnaire (seizure/not seizure)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Gelfand, MD, PhD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Hövding Inc. may receive the used helmets and the information about how they were deployed. All information shared will be deidentified.
Citations:
PubMed Identifier
8551320
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.
Results Reference
background
Links:
URL
https://hovding.com/
Description
Hovding - Airbag for Cyclists
Learn more about this trial
Novel Helmet Design in Patients With Seizures
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