NCT03443388

Novel Helmet Design in Patients With Seizures

Completed NA Results posted Last updated 9 January 2025

What this trial tests

NA trial testing Hövding inflatable helmet in Drug Resistant Epilepsy in 9 participants. Completed in 20 March 2020.

Timeline

14 August 2017

Primary endpoint
15 December 2019

20 March 2020

Quick facts

Lead sponsor	Michael A. Gelfand, MD, PhD
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	none
Primary purpose	prevention
Enrollment	9
Start date	14 August 2017
Primary completion	15 December 2019
Estimated completion	20 March 2020
Sites	1 location across United States

Drugs / interventions tested

• Hövding inflatable helmet

Conditions studied

• Drug Resistant Epilepsy — all drugs for Drug Resistant Epilepsy →
• Drop Seizures — all drugs for Drop Seizures →
• Generalized Tonic Clonic Seizure — all drugs for Generalized Tonic Clonic Seizure →
• Complex Partial Seizure — all drugs for Complex Partial Seizure →

Sponsor

Michael A. Gelfand, MD, PhD

Who can join

Adults 18 to 60, any sex, with Drug Resistant Epilepsy or Drop Seizures. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 1: Number of Successful Deployments Primary · 1 day

3 out of 4 successful deployments was set as a criteria to allow advancement to part 2.

Successful Helmet Deployments

Group	Value	95% CI
Phase 1: Staged Fall	4

Unsuccessful Helmet Deployments

Group	Value	95% CI
Phase 1: Staged Fall	0

Part 2: Helmet Deployment Questionnaire Primary · 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.

Participants with evaluable falls

Group	Value	95% CI
Helmet	3
No Helmet	2

Participants without evaluable fall

Group	Value	95% CI
Helmet	2
No Helmet	2

Participants lost to follow up before evaluation of fall completed

Group	Value	95% CI
Helmet	0
No Helmet	1

Helmet did not deploy with evaluable fall

Group	Value	95% CI
Helmet	1

helmet deployed after evaluable fall

Group	Value	95% CI
Helmet	2

Patients with Minor Abrasions/Lacerations to head after a fall

Group	Value	95% CI
Helmet	0
No Helmet	2

Patients with ER visit due to fall

Group	Value	95% CI
Helmet	0
No Helmet	1

Rivermead Post Concussive Scale Secondary · 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. The scale for each item of this survey: 0 = not experienced at all 1 = no more of a problem 2 = a mild problem 3 = a moderate problem 4 = a severe problem. Each item was assessed as "compared with before the accident, do you now (i.e., o

Group	Value	95% CI
Phase 2 Participant Data	0	0 – 0
Participants Randomized to no Helmet	21.5	0 – 43

Seizure Questionnaire Secondary · 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.

Group	Value	95% CI
Phase 2 Participants Who Wore the Helmet	0
Phase 2 Participants Not Wearing Helmet	2
Phase 2 Participants Who Wore the Helmet	3
Phase 2 Participants Not Wearing Helmet	0
Phase 2 Participants Who Wore the Helmet	2
Phase 2 Participants Not Wearing Helmet	2

Injury-related Medical Record Review Secondary · 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.

Participants who had an evaluable fall

Group	Value	95% CI
Helmet	3
No Helmet	2

Participants who had an evaluable fall caused by a seizure

Group	Value	95% CI
Helmet	1
No Helmet	2

Participants whose helmet deployed during a non-seizure evaluable fall

Group	Value	95% CI
Helmet	2

Participants whose helmet did not deploy during an evaluable fall

Group	Value	95% CI
Helmet	1

Participants injured after evaluable fall

Group	Value	95% CI
Helmet	0
No Helmet	2

Helmet Deployment Questionnaire (Seizure/Not Seizure) Secondary · 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.

Group	Value	95% CI
Helmet	0
Helmet	0
Helmet	1
Helmet	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1

Serious: 0/4 (0%)

Deaths: 0/4

Phase 2: Subjects Wearing a Helmet

Serious: 0/5 (0%)

Deaths: 0/5

Phase 2: Subjects Not Wearing a Helmet

Serious: 0/4 (0%)

Deaths: 0/4

Other adverse events (1 terms — click to expand)

Reaction	System	Phase 1	Phase 2: Subjects Wearing …	Phase 2: Subjects Not Wear…
Minor abrasions/head lacerations	Musculoskeletal and connective tissue disorders	—	—	—

Data from ClinicalTrials.gov NCT03443388 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.