CompletedNot Applicable

Novel Helmet Design in Patients With Seizures

United States9 participantsStarted 2017-08-14

Plain-language 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.

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Part 1: Number of Successful Deployments

Timeframe: 1 day

Part 2: Helmet Deployment Questionnaire

Timeframe: 6 months

Trial details

NCT IDNCT03443388

SponsorMichael A. Gelfand, MD, PhD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12-15

Results submitted2024-09-02

View on ClinicalTrials.gov More Drug Resistant Epilepsy trials