N/A
Completed N=9
Novel Helmet Design in Patients With Seizures
Epilepsy · Drop Seizures · Generalized Tonic Clonic Seizure · Complex Partial Seizure
Source: ClinicalTrials.gov NCT03443388 ↗
Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: Part 1: Number of Successful Deployments — 4; 0 number of successful deployments
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Number of Successful Deployments |
4; 0 | — |
| PRIMARY Part 2: Helmet Deployment Questionnaire |
3; 2; 2; 2; 0; 1 | — |
| SECONDARY Rivermead Post Concussive Scale |
0; 21.5 | — |
| SECONDARY Seizure Questionnaire |
0; 2; 3; 0; 2; 2 | — |
| SECONDARY Injury-related Medical Record Review |
3; 2; 1; 2; 2; 1 | — |
| SECONDARY Helmet Deployment Questionnaire (Seizure/Not Seizure) |
0; 0; 1; 1; 1 | — |
Eligibility Criteria
Inclusion Criteria
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.
- Able to read, speak, and understand English.
Exclusion Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03443388). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.