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Novel Helmet Design in Patients With Seizures

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ClinicalTrials.gov Identifier: NCT03443388
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : October 29, 2018
Sponsor:
Collaborator:
Epilepsy Foundation
Information provided by (Responsible Party):
Michael A. Gelfand, MD, PhD, University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Drug Resistant Epilepsy Drop Seizures Generalized Tonic Clonic Seizure Complex Partial Seizure Fall Due to Seizure Device: Hövding inflatable helmet Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Pilot Study of the Safety of a Novel Helmet Design in Patients With Seizures
Actual Study Start Date : August 14, 2017
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arm Intervention/treatment
Active Comparator: Part 2: Helmet
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
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.

No Intervention: Part 2: No Helmet
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.



Primary Outcome Measures :
  1. Part 1: Number of times the helmet deploys during staged fall [ Time Frame: 1 day ]
    Will proceed to Part 2 if helmet deployment in at least 3 out of 4 falls

  2. Part 2: Helmet Deployment Questionnaire (helmet/no helmet) [ Time Frame: 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 Outcome Measures :
  1. Rivermead Post Concussive Scale [ Time Frame: 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.

  2. Seizure Questionnaire [ Time Frame: 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.

  3. Injury-related Medical Record Review [ Time Frame: 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.

  4. Helmet Deployment Questionnaire (seizure/not seizure) [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443388


Contacts
Contact: Meryl Lozano, MBE 215-662-7227 meryl.lozano@uphs.upenn.edu
Contact: Ashlie Jefferson, MA 215-662-7227 ashlie.jefferson@uphs.upenn.edu

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Meryl Lozano, MBE    215-662-7227    meryl.lozano@uphs.upenn.edu   
Contact: Ashlie Jefferson, MA    2156627227    ashlie.jefferson@uphs.upenn.edu   
Principal Investigator: Michael Gelfand, MD, PhD         
Sub-Investigator: David Coughlin, MD         
Sponsors and Collaborators
Michael A. Gelfand, MD, PhD
Epilepsy Foundation
Investigators
Principal Investigator: Michael Gelfand, MD, PhD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by Michael A. Gelfand, MD, PhD, University of Pennsylvania:
Study Protocol  [PDF] January 30, 2018


Additional Information:
Publications:
Responsible Party: Michael A. Gelfand, MD, PhD, Assistant Professor of Clinical Neurology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03443388     History of Changes
Other Study ID Numbers: 824620
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Hövding Inc. may receive the used helmets and the information about how they were deployed. All information shared will be deidentified.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michael A. Gelfand, MD, PhD, University of Pennsylvania:
head injury from seizures
seizures resulting in fall
helmet for seizures
novel helmet design
inflatable helmet
Hovding Inc
helmet
device

Additional relevant MeSH terms:
Seizures
Drug Resistant Epilepsy
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms