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NCT05103566 · ClinicalTrials.gov registry record · NA
Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
A NA study of Subarachnoid Hemorrhage, Aneurysmal, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05103566: Recruiting NA study of Subarachnoid Hemorrhage, Aneurysmal, sponsored by Massachusetts General Hospital.
NCT05103566 is a NA study of Subarachnoid Hemorrhage, Aneurysmal that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 25 participants, below the 160-participant average among 8 other Subarachnoid Hemorrhage, Aneurysmal trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05103566, a NA study of Subarachnoid Hemorrhage, Aneurysmal, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-site, single-arm, open-label pilot study assessing the safety, feasibility, and efficacy of non-invasive vagus nerve stimulation (nVNS), gammaCore, for the acute treatment of aneurysmal subarachnoid hemorrhage (SAH) subjects in a neurocritical care setting. 25 patients will be enrolled, all treated with an active device. The primary efficacy outcomes are reduced aneurysm rupture rate, reduced seizure and seizure-spectrum activity, minimized hemorrhage grades, and increased survival.
Primary Outcome
The rate of serious adverse events, such as bradycardia, hypotension, and decline in modified Glasgow Coma Scale grade. Events are determined through continuous monitoring of vital signs, including but not limited to: blood pressure, O2 saturation, heart rate, routine blood work, EKG, and alarm trigger frequency.
Conditions Studied
Interventions
- DEVICE gammaCore
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-10-04 |
| Est. Completion | 2026-04 |
| Phase | NA |
What NCT05103566 shows while recruiting
NCT05103566 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 160-participant average among 8 other Subarachnoid Hemorrhage, Aneurysmal trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Subarachnoid Hemorrhage, Aneurysmal appearing as the primary indexed condition, and to 1 intervention - of which gammaCore is the first listed.
NCT05103566 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT05103566 about?
NCT05103566 is a clinical study titled "Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage". This is a single-site, single-arm, open-label pilot study assessing the safety, feasibility, and efficacy of non-invasive vagus nerve stimulation (nVNS), gammaCore, for the acute treatment of aneurysmal subarachnoid hemorrhage (SAH) subjects in a neurocritical care setting. 25 patients will be enrol...
What is the current status of trial NCT05103566?
This trial is currently recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2022-10-04. Estimated completion is 2026-04.
What conditions does trial NCT05103566 study?
This clinical trial studies the following conditions: Subarachnoid Hemorrhage, Aneurysmal.
What interventions are being tested in trial NCT05103566?
The interventions under investigation include: gammaCore (DEVICE).
Who is sponsoring clinical trial NCT05103566?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05103566 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Subarachnoid Hemorrhage, Aneurysmal
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05103566's enrollment target sits among peer trials
25 4th of 8 higher than 5 of 8 other Subarachnoid Hemorrhage, Aneurysmal trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Subarachnoid Hemorrhage, Aneurysmal trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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