An interventional study of Hövding inflatable helmet in Drug Resistant Epilepsy, Drop Seizures and Generalized Tonic Clonic Seizure, sponsored by Michael A. Gelfand, MD, PhD. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-09.
Sponsored by Michael A. Gelfand, MD, PhD · Not applicable, Interventional, and Prevention
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.
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.
257 studies on the registry are indexed under Drug Resistant Epilepsy; 108 are open to participants now.
This study's enrollment of 9 is below the median of 30 across 202 interventional studies indexed under Drug Resistant Epilepsy.
Browse Drug Resistant Epilepsy studies →This is the only study on the registry with Michael A. Gelfand, MD, PhD as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Part 1:
Part 2:
Exclusion Criteria:
Part 1:
Part 2:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Hövding inflatable helmet
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.
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.
Part 1: Number of Successful Deployments
3 out of 4 successful deployments was set as a criteria to allow advancement to part 2.
Time frame: 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.
Time frame: 6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
4 subjects for part 1. 5 subjects for part 2
| Milestone | Part 1: Staged Fall | Part 2: Helmet First, Then no Helmet | Part 2: No Helmet First, Then Helmet |
|---|---|---|---|
| Started | 4 | 3 | 2 |
| Completed | 4 | 2 | 2 |
| Not completed | 0 | 1 | 0 |
3 out of 4 successful deployments was set as a criteria to allow advancement to part 2.
| number of successful deployments | Phase 1: Staged Fall |
|---|---|
| Successful Helmet Deployments | 4 |
| Unsuccessful Helmet Deployments | 0 |
Differences in Helmet Deployment Questionnaire responses will be compared between subjects wearing helmets during a seizure, and subjects not wearing helmets during a seizure.
| participants | Helmet | No Helmet |
|---|---|---|
| Participants with evaluable falls | 3 | 2 |
| Participants without evaluable fall | 2 | 2 |
| Participants lost to follow up before evaluation of fall completed | 0 | 1 |
| Helmet did not deploy with evaluable fall | 1 | — |
| helmet deployed after evaluable fall | 2 | — |
| Patients with Minor Abrasions/Lacerations to head after a fall | 0 | 2 |
| Patients with ER visit due to fall | 0 | 1 |
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.
| Average Rivermead Score | Phase 2 Participant Data | Participants Randomized to no Helmet |
|---|---|---|
| Rivermead Post Concussive Scale | 0 (0 to 0) | 21.5 (0 to 43) |
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.
| Participants | Phase 2 Participants Who Wore the Helmet | Phase 2 Participants Not Wearing Helmet |
|---|---|---|
| Injury resulting from evaluable fall | 0 | 2 |
| No injury resulting from fall | 3 | 0 |
| No evaluable fall | 2 | 2 |
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.
| Participants | Helmet | No Helmet |
|---|---|---|
| Participants who had an evaluable fall | 3 | 2 |
| Participants who had an evaluable fall caused by a seizure | 1 | 2 |
| Participants whose helmet deployed during a non-seizure evaluable fall | 2 | — |
| Participants whose helmet did not deploy during an evaluable fall | 1 | — |
| Participants injured after evaluable fall | 0 | 2 |
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.
| Participants | Helmet |
|---|---|
| Helmet deployed during fall from seizure | 0 |
| Helmet did not deploy | 0 |
| Helmet deployed when standing while having a seizure | 1 |
| Helmet deployed for a non-seizure related fall | 1 |
| Helmet deployed while sitting rapidly from standing | 1 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1 | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Phase 2: Subjects Wearing a Helmet | 0/5 (0%) | 0/5 (0%) | 0/5 (0%) |
| Phase 2: Subjects Not Wearing a Helmet | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Event | Phase 1 | Phase 2: Subjects Wearing a Helmet | Phase 2: Subjects Not Wearing a Helmet |
|---|---|---|---|
| Minor abrasions/head lacerationsMusculoskeletal and connective tissue disorders | — | — | 2/4 |
| Age, Categorical(Participants) | Phase 2 (Crossover) | Phase 1 (Staged Fall) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 4 | 9 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Phase 2 (Crossover) | Phase 1 (Staged Fall) | Total |
|---|---|---|---|
| Median | 39 (26 to 54) | 36.5 (27 to 44) | 39 (26 to 54) |
| Sex: Female, Male(Participants) | Phase 2 (Crossover) | Phase 1 (Staged Fall) | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 3 | 2 | 5 |
| Race and Ethnicity Not Collected(Participants) | Phase 2 (Crossover) | Phase 1 (Staged Fall) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Phase 2 (Crossover) | Phase 1 (Staged Fall) | Total |
|---|---|---|---|
| United States | 5 | 4 | 9 |
| Type of Epilepsy(Participants) | Phase 2 (Crossover) | Phase 1 (Staged Fall) | Total |
|---|---|---|---|
| Focal Epilepsy | 3 | 0 | 3 |
| Generalized Epilepsy | 1 | 0 | 1 |
| Lennox-Gastaut Syndrome | 1 | 0 | 1 |
| No epilepsy diagnosis (control) | 0 | 4 | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Hövding Inc. may receive the used helmets and the information about how they were deployed. All information shared will be deidentified.
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