CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
gammaCoredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04126408
NCT04126408N/ACompleted
CompareCT.gov

Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage

Northwell Health·interventional·Posted Oct 15, 2019·Updated Jan 9, 2024

In Brief

A clinical study evaluating gammaCore for Subarachnoid Hemorrhage, Aneurysmal. Completed, enrolled 40 participants across 1 site.

Detailed Summary

This is a single site, randomized, sham-controlled, double blinded pilot study assessing the feasibility, safety, tolerability, and efficacy of non-invasive VNS (nVNS), gammaCore, in the treatment of headache in subarachnoid hemorrhage (SAH). 40 participants will be enrolled, 20 in the active device arm and 20 in the sham arm. The primary efficacy outcome is the the difference between the active and sham treatment groups in morphine equivalence dosage.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubarachnoid Hemorrhage, Aneurysmal
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 15, 2019
Enrollment StartJan 13, 2020
Primary CompletionJun 20, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.7 years ago

Interventions

gammaCoredevice

The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache.