Drug Resistant EpilepsyNCT03443388
Novel Helmet Design in Patients With Seizures
A study testing Hövding inflatable helmet in people with Drug Resistant Epilepsy and Drop Seizures, run by Michael A. Gelfand, MD, PhD at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Resistant Epilepsy, Drop Seizures, Generalized Tonic Clonic Seizure
- What is being tested?
- Hövding inflatable helmet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 20 Mar 2020
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Pilot Study of the Safety of a Novel Helmet Design in Patients With Seizures
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.
Read the 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.
- Conditions
- Drug Resistant Epilepsy, Drop Seizures, Generalized Tonic Clonic Seizure, Complex Partial Seizure, Fall Due to Seizure
- Being tested
- Hövding inflatable helmet
- Keywords
- head injury from seizures, seizures resulting in fall, helmet for seizures, novel helmet design, inflatable helmet, Hovding Inc, helmet, device
- Medical subject headings
- Drug Resistant Epilepsy, Syncope, Epilepsy, Tonic-Clonic, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hövding inflatable helmetDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Part 2: Helmet | Active comparator | 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. Receives: Device: Hövding inflatable helmet |
| Part 2: No Helmet | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Successful Deployments
3 out of 4 successful deployments was set as a criteria to allow advancement to part 2.
Measured: 1 day
Part 2: Helmet Deployment Questionnaire
Differences in Helmet Deployment Questionnaire responses will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure.
Measured: 6 months
Secondary outcomes (4)
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. The scale for each item of this survey: 0 = not experienced at all 1 = no more of a problem 2 = a mild problem 3 = a moderate problem 4 = a severe problem. Each item was assessed as "compared with before the accident, do you now (i.e., over the last 24 hours) suffer from:" or "Are you experiencing any other difficulties?" with a write in option with the same scale. A lower score on each item is better, indicating lesser symptom severity compared to prior to falling with or without the helmet. The score for each item is summed to obtain each patient's total, indicative of total symptom severity. Total range from 0 - 72.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start14 Aug 2017
- Primary completion15 Dec 2019
- Study completion20 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Drug Resistant EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael A. Gelfand, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Epilepsy Foundation
- Responsible party
- Sponsor-investigator, Michael A. Gelfand, MD, PhD, University of Pennsylvania
- Investigators
- Michael Gelfand, MD, PhD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443388
- Sponsor's protocol ID
- 824620
- Status last verified
- Jan 2025
- First submitted
- 7 Feb 2018
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: Hövding Inc. may receive the used helmets and the information about how they were deployed. All information shared will be deidentified.
Publications
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.
PubMed 8551320