You are being invited to join a research study of an investigational helmet for use in patients with seizures. We are looking for patients over 18-years-old with seizures that happen once every two months or more, and patients who have at least one seizure every 6 months that might result in a fall. We hope that this new type of helmet may be useful in preventing head injuries during seizures. The helmet is manufactured by Hövding Inc. for use by bicyclists and is commercially available in the European Union. However, the helmet has not yet been approved in the U.S. for any purpose. Hence, it has not been approved by the U.S. Food & Drug Administration (FDA) for use as a safety device in people with seizures.
The purpose of this study is to learn whether the Hövding helmet is safe to use in patients with seizures. All of the people participating in this study will receive the helmet as part of study participation. The helmet is a collar that works by sensing changes in speed. When a significant change in speed is detected, the helmet inflates and wraps an inflatable cushion around the sides and top of the head, similar to an airbag. Patients who fall from standing during their seizures also undergo large changes in speed. This helmet may prove to be safe and efficacious in for preventing injuries during seizures. The helmet has been tested extensively in Europe for use by bicyclists, and currently, is available for purchase. The company plans to obtain approval in the US for bicyclists in the future. The helmet has not been tested as a safety device in any setting other than bicycling, including in seizures.
Seizures can be dangerous. Many patients experience falls that lead to significant head injuries, including facial lacerations (cuts), contusions (bruises), concussions and skull fractures (broken bone).
Study Identifier: 824620
Contact the research team to learn more about this study.