Complex Partial Seizure, Drop Seizures, Drug Resistant Epilepsy, Fall Due to Seizure, Generalized Tonic Clonic Seizure
Conditions
Keywords
head injury from seizures, seizures resulting in fall, helmet for seizures, novel helmet design, inflatable helmet, Hovding Inc, helmet, device
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.
Interventions
DEVICEHövding 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.
Sponsors
Epilepsy Foundation
Michael A. Gelfand, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Successful Deployments | 1 day | 3 out of 4 successful deployments was set as a criteria to allow advancement to part 2. |
| Part 2: Helmet Deployment Questionnaire | 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Rivermead Post Concussive Scale | 6 months | 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. |
| Seizure Questionnaire | 6 months | 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 | 6 months | 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) | 6 months | 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. |
Countries
United States
Participant flow
Recruitment details
4 subjects for part 1. 5 subjects for part 2
Participants by arm
| Arm | Count |
|---|---|
| Phase 2 (Crossover) All participants who agreed to participate in Phase 2 of the study | 5 |
| Phase 1 (Staged Fall) All participants who agreed to participate in Phase 1 of the study | 4 |
| Total | 9 |
Baseline characteristics
| Characteristic | Phase 1 (Staged Fall) | Phase 2 (Crossover) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 5 Participants | 9 Participants |
| Age, Continuous | 36.5 years | 39 years | 39 years |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 4 participants | 5 participants | 9 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
| Type of Epilepsy Focal Epilepsy | 0 Participants | 3 Participants | 3 Participants |
| Type of Epilepsy Generalized Epilepsy | 0 Participants | 1 Participants | 1 Participants |
| Type of Epilepsy Lennox-Gastaut Syndrome | 0 Participants | 1 Participants | 1 Participants |
| Type of Epilepsy No epilepsy diagnosis (control) | 4 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 5 | 2 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 5 | 0 / 4 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: Staged Fall | Part 1: Number of Successful Deployments | Successful Helmet Deployments | 4 number of successful deployments |
| Phase 1: Staged Fall | Part 1: Number of Successful Deployments | Unsuccessful Helmet Deployments | 0 number of successful deployments |
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.
Time frame: 6 months
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1: Staged Fall | Part 2: Helmet Deployment Questionnaire | helmet deployed after evaluable fall | 2 participants |
| Phase 1: Staged Fall | Part 2: Helmet Deployment Questionnaire | Patients with Minor Abrasions/Lacerations to head after a fall | 0 participants |
| Phase 1: Staged Fall | Part 2: Helmet Deployment Questionnaire | Participants without evaluable fall | 2 participants |
| Phase 1: Staged Fall | Part 2: Helmet Deployment Questionnaire | Patients with ER visit due to fall | 0 participants |
| Phase 1: Staged Fall | Part 2: Helmet Deployment Questionnaire | Participants with evaluable falls | 3 participants |
| Phase 1: Staged Fall | Part 2: Helmet Deployment Questionnaire | Participants lost to follow up before evaluation of fall completed | 0 participants |
| Phase 1: Staged Fall | Part 2: Helmet Deployment Questionnaire | Helmet did not deploy with evaluable fall | 1 participants |
| No Helmet | Part 2: Helmet Deployment Questionnaire | Patients with ER visit due to fall | 1 participants |
| No Helmet | Part 2: Helmet Deployment Questionnaire | Participants with evaluable falls | 2 participants |
| No Helmet | Part 2: Helmet Deployment Questionnaire | Participants without evaluable fall | 2 participants |
| No Helmet | Part 2: Helmet Deployment Questionnaire | Patients with Minor Abrasions/Lacerations to head after a fall | 2 participants |
| No Helmet | Part 2: Helmet Deployment Questionnaire | Participants lost to follow up before evaluation of fall completed | 1 participants |
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: Staged Fall | Helmet Deployment Questionnaire (Seizure/Not Seizure) | Helmet deployed during fall from seizure | 0 Participants |
| Phase 1: Staged Fall | Helmet Deployment Questionnaire (Seizure/Not Seizure) | Helmet did not deploy | 0 Participants |
| Phase 1: Staged Fall | Helmet Deployment Questionnaire (Seizure/Not Seizure) | Helmet deployed when standing while having a seizure | 1 Participants |
| Phase 1: Staged Fall | Helmet Deployment Questionnaire (Seizure/Not Seizure) | Helmet deployed for a non-seizure related fall | 1 Participants |
| Phase 1: Staged Fall | Helmet Deployment Questionnaire (Seizure/Not Seizure) | Helmet deployed while sitting rapidly from standing | 1 Participants |
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.
Time frame: 6 months
Population: No individual subject had falls from seizures during both the helmet and no-helmet periods.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: Staged Fall | Injury-related Medical Record Review | Participants who had an evaluable fall | 3 Participants |
| Phase 1: Staged Fall | Injury-related Medical Record Review | Participants whose helmet deployed during a non-seizure evaluable fall | 2 Participants |
| Phase 1: Staged Fall | Injury-related Medical Record Review | Participants whose helmet did not deploy during an evaluable fall | 1 Participants |
| Phase 1: Staged Fall | Injury-related Medical Record Review | Participants injured after evaluable fall | 0 Participants |
| Phase 1: Staged Fall | Injury-related Medical Record Review | Participants who had an evaluable fall caused by a seizure | 1 Participants |
| No Helmet | Injury-related Medical Record Review | Participants who had an evaluable fall | 2 Participants |
| No Helmet | Injury-related Medical Record Review | Participants injured after evaluable fall | 2 Participants |
| No Helmet | Injury-related Medical Record Review | Participants who had an evaluable fall caused by a seizure | 2 Participants |
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.
Time frame: 6 months
Population: 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).
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Phase 1: Staged Fall | Rivermead Post Concussive Scale | 0 Average Rivermead Score |
| No Helmet | Rivermead Post Concussive Scale | 21.5 Average Rivermead Score |
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.
Time frame: 6 months
Population: Participants who were or did not wear the helmet for whom data is available (e.g., were not lost to follow up).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1: Staged Fall | Seizure Questionnaire | Injury resulting from evaluable fall | 0 Participants |
| Phase 1: Staged Fall | Seizure Questionnaire | No injury resulting from fall | 3 Participants |
| Phase 1: Staged Fall | Seizure Questionnaire | No evaluable fall | 2 Participants |
| No Helmet | Seizure Questionnaire | Injury resulting from evaluable fall | 2 Participants |
| No Helmet | Seizure Questionnaire | No injury resulting from fall | 0 Participants |
| No Helmet | Seizure Questionnaire | No evaluable fall | 2 Participants |