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| Name | Class |
|---|---|
| Epilepsy Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hövding inflatable helmet | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Successful Deployments | 3 out of 4 successful deployments was set as a criteria to allow advancement to part 2. | 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Part 1:
Part 2:
Exclusion Criteria:
Part 1:
1. Subject is currently pregnant
Part 2:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gelfand, MD, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8551320 | Background | 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. |
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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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4 subjects for part 1. 5 subjects for part 2
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Staged Fall | Four healthy volunteers were enrolled in Phase 1 of the study to assess the reliability of helmet deployment during staged falls |
| FG001 | Part 2: Helmet First, Then no Helmet | This was a randomized crossover study; subjects were initially randomized to either 'helmet' or 'no helmet' groups; after the first evaluable fall they crossed into the other group. |
| FG002 | Part 2: No Helmet First, Then Helmet | This was a randomized crossover study; subjects were initially randomized to either 'helmet' or 'no helmet' groups; after the first evaluable fall they crossed into the other group. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 2 (Crossover) | All participants who agreed to participate in Phase 2 of the study |
| BG001 | Phase 1 (Staged Fall) | All participants who agreed to participate in Phase 1 of the study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Part 1: Number of Successful Deployments | 3 out of 4 successful deployments was set as a criteria to allow advancement to part 2. | Posted | Number | number of successful deployments | 1 day | Helmet Deployments | Helmet Deployments |
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1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1 | All participants in phase 1 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor abrasions/head lacerations | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Gelfand, MD, PhD | University of Pennsylvania | 215 662 3606 | epilepsytrials@pennmedicine.upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2018 | Oct 18, 2024 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D000069279 | Drug Resistant Epilepsy |
| D013575 | Syncope |
| D004830 | Epilepsy, Tonic-Clonic |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| 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. | 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. | 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. | 6 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type of Epilepsy | Count of Participants | Participants |
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| Helmet Deployments |
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| Primary | 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. | 3 participants had evaluable falls with the helmet; 2 participants had evaluable falls without a helmet. Only 1 patient had an evaluable fall in both helmet and no-helmet conditions. | Posted | Number | participants | 6 months |
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| 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. 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. | Rivermead scales were not collected consistently enough to be analyzed as intended. However, data presented include average Rivermead score of those for whom data was obtained. No individual participant completed the scale at each time point. Data was obtained for one participant with a fall with helmet (0, helmet did not deploy), and two participants with a fall without a helmet (0 and 43). | Posted | Mean | Full Range | Average Rivermead Score | 6 months |
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| 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. | Participants who were or did not wear the helmet for whom data is available (e.g., were not lost to follow up). | Posted | Count of Participants | Participants | 6 months |
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|
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| 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. | No individual subject had falls from seizures during both the helmet and no-helmet periods. | Posted | Count of Participants | Participants | 6 months |
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| 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. | Posted | Count of Participants | Participants | 6 months |
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| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Phase 2: Subjects Wearing a Helmet | All participants in phase 2 who wore a helmet | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Phase 2: Subjects Not Wearing a Helmet | All participants randomized in phase 2 who did not wear a helmet | 0 | 4 | 0 | 4 | 2 | 4 |
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| D014474 |
| Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004829 | Epilepsy, Generalized |
| Lennox-Gastaut Syndrome |
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| No epilepsy diagnosis (control) |
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| Participants without evaluable fall |
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| Participants lost to follow up before evaluation of fall completed |
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| Helmet did not deploy with evaluable fall |
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| helmet deployed after evaluable fall |
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| Patients with Minor Abrasions/Lacerations to head after a fall |
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| Patients with ER visit due to fall |
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| No evaluable fall |
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| Participants who had an evaluable fall caused by a seizure |
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| Participants whose helmet deployed during a non-seizure evaluable fall |
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| Participants whose helmet did not deploy during an evaluable fall |
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| Participants injured after evaluable fall |
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| Helmet deployed for a non-seizure related fall |
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| Helmet deployed while sitting rapidly from standing |
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