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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 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.

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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.

Interventions

  • DEVICE gammaCore

Study Locations (1)

Massachusetts

  • Massachusetts General Hospital - Boston

Trial Details

FieldValue
Enrollment Target 25 participants
Start Date 2022-10-04
Est. Completion 2026-04
Phase NA

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT05103566

The ClinicalTrials.gov registry entry for NCT05103566 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 25 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 160-participant average among 8 other Subarachnoid Hemorrhage, Aneurysmal trials with a reported enrollment target (84% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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