A Pilot Study of a Novel Helmet Design in Patients with Seizures
Abstract number :
2.506
Submission category :
8. Non-ASM/Non-Surgical Treatments (Hormonal, alternative, etc.)
Year :
2023
Submission ID :
1396
Source :
www.aesnet.org
Presentation date :
12/3/2023 12:00:00 AM
Published date :
Authors :
Presenting Author: Bilal Morsi, BA – University of Pennsylvania
Sabrina Herzberg, BS – University of Pennsylvania; Emily Killian, BA – University of Pennsylvania; Melissa Johnston Esparza, MS – University of Pennsylvania; Ashlie Jefferson, MA – University of Pennsylvania; Meryl Lozano, MBE – University of Pennsylvania; David Coughlin, MD – University of Pennsylvania; John Pollard, MD – University of Pennsylvania; Taneeta Ganguly, MD – University of Pennsylvania; Michael Gelfand, MD/PhD – University of Pennsylvania
Rationale: Patients with epilepsy may sustain head injuries from falls caused by seizures. A subset of patients with difficult-to-control seizures wear helmets to limit the risk of injury. However, helmets are worn infrequently due in part to social stigma and impracticality. A less obtrusive helmet designed by Hövding rapidly inflates in response to the acceleration from a fall. We speculated that this alternative helmet design may lower barriers to helmet use in people with epilepsy. The primary objective of this study was to gather preliminary data on the usability and safety of the Hövding helmet in preventing head injuries in patients with epilepsy.
Methods: During Phase 1, four healthy volunteers staged a fall from a standing position while wearing the helmet. Phase 2 was a randomized unblinded crossover study. In Phase 2, subjects with drug-resistant epilepsy and a history of seizures leading to falls were recruited; subjects already wearing helmets for seizure safety were excluded. Subjects were initially randomized to either the ‘helmet’ or ‘no helmet’ groups; after the first evaluable fall, they crossed into the other group. Subjects completed a daily seizure calendar and questionnaires regarding the circumstances of the seizure/fall and helmet deployment.
Results: During Phase 1, the helmet successfully deployed during volitional fall from standing in all four subjects. Subjects reported adverse events of mild headache, mild head/neck pain, and dizziness. In Phase 2, five subjects were recruited. The helmet deployed for two subjects and did not deploy in one subject who experienced a fall during a seizure. ’ group and another subject was lost to follow-up after receiving the helmet device. In the deployment cases, the helmet did not inflate in response to a reported seizure. One subject’s helmet deployed inappropriately while sitting rapidly from standing. The other subject’s helmet deployed appropriately with a mechanical fall. While not a seizure, the subject felt that the deployment had been helpful in protection during the fall, and no injuries were sustained.
Conclusions: The helmet, if deployed, provided benefits during falls from a standing position by preventing possible injuries. Subjects could not reuse the helmet after its initial deployment, which presents a potential obstacle to long-term use in patients with repeated seizures. Additionally, the current helmet design lacks specificity in its detection of movements experienced during a fall, suggesting that modifications to improve this function are critical prior to future wider use. While the Hövding inflatable helmet was more tolerable than a typical seizure protective helmet, our findings suggest that a smaller and lighter reusable device would be more easily tolerated. Future studies may benefit from including patients with syncope or gait dysfunction who may have more frequent falls than patients with epilepsy may. The idea of an inflatable, less obtrusive protective helmet for individuals at risk for falls is appealing and should continue to be pursued with efficacy and chronic usability in mind.
Funding: N/A
Non-ASM