Novel Helmet Design in Patients With Seizures

NCT03443388 | Completed Results FDA Device

• 1 other identifier: 824620
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Resistant Epilepsy; Drop Seizures; Generalized Tonic Clonic Seizure; Complex Partial Seizure; Fall Due to Seizure

Keywords

head injury from seizures; seizures resulting in fall; helmet for seizures; novel helmet design; inflatable helmet; Hovding Inc; helmet; device

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Rivermead Post Concussive Scale

  6 months

• Seizure Questionnaire

  6 months

• Injury-related Medical Record Review

  6 months

• Helmet Deployment Questionnaire (Seizure/Not Seizure)

  6 months

Study Arms (2)

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.

Device: Hövding inflatable helmet

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.

Interventions

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.

Part 2: Helmet

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Part 1:
• Age 18-60 at the time of enrollment.
• Have neck circumference between 34 and 42 cm.
• Can understand and provide written informed consent.
• Must be competent to follow all study procedures.
• Able to read, speak, and understand English.
• Part 2:
• 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).
• Has a seizure frequency of at least once per 2 months.
• Be between ages 18-65 at the time of enrollment.
• Have neck circumference between 34 and 42 cm
• Must live in a home with electrical power supply.
• 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.
• Can understand and sign written informed consent.
• Must be competent to follow all study procedures.

You may not qualify if:

• Part 1:
• \. Subject is currently pregnant
• Part 2:
• Patient already wears a helmet for seizure safety.
• Subject is pregnant, planning to become pregnant during the study, or is unwilling to use an appropriate form of birth control during the study.

Sponsors & Collaborators

• Michael A. Gelfand, MD, PhD: lead
• Epilepsy Foundation: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 8551320 BACKGROUND

MeSH Terms

Conditions

Drug Resistant Epilepsy; Syncope; Epilepsy, Tonic-Clonic; Seizures

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Epilepsy, Generalized

Results Point of Contact

• Title: Michael Gelfand, MD, PhD
• Organization: University of Pennsylvania

epilepsytrials@pennmedicine.upenn.edu

215 662 3606

Study Officials

• Michael Gelfand, MD, PhD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Clinical Neurology

Model Details: 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.

Study Record Dates

• First Submitted: February 7, 2018
• First Posted: February 23, 2018
• Study Start: August 14, 2017
• Primary Completion: December 15, 2019
• Study Completion: March 20, 2020
• Last Updated: January 9, 2025
• Results First Posted: January 9, 2025

Record last verified: 2025-01

Locations

US (1)