Safety, Feasibility, and Efficacy of Non-invasive Vagus Nerve Stimulation (nVNS) in the Treatment of Aneurysmal Subarachnoid Hemorrhage
A legfontosabb adatok
- Hol
- Boston (Egyesült Államok)A helyszín megnézése
Neked szólhat?
Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.
- 18 és 85 év között vagy?
Forrás: NCT05103566: ki vehet részt
Helyszínek itt: Egyesült Államok
- Massachusetts General HospitalBoston, Egyesült ÁllamokContact: Aman B Patel, MDRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Massachusetts General Hospital
- Azonosító
- NCT05103566
- A regiszteradat frissítve
- 2026. május 14.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
STORM: 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 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.
Bevonási feltételek: Male or female, 18-85 years of age; Ruptured aneurysmal SAH confirmed by angiography and repaired by neurosurgical clipping or endovascular occlusion (coiling); Modified Glasgow Coma Scale (mGCS) score ≥ 10 and Hunt Hess 1-4 within 72 hours of presumed aneurysm rupture; Enrollment and initiation of nVNS treatment must occur within 72 hours of presumed aneurysm rupture; Provide a legally obtained informed consent form from the participant or the legally authorized representative (LAR); telephonic consent is acceptable; Female participants of reproductive age must have a negative pregnancy test result (urine or blood).
Kizáró feltételek: Use of any concomitant electrostimulation device, including a pacemaker, defibrillator, or deep brain stimulator; Previous neck dissection or radiation; Currently participating in an investigational drug or device clinical trial with potential to confound data collection; History of carotid artery disease or carotid surgery/dissection; History of secondary or tertiary heart blocks, ventricular tachycardia, or supraventricular tachycardia (SVT; including atrial fibrillation); No plan to secure aneurysm, defined as aneurysm that has not been surgically or endovascularly treated; Screws, metals, or devices in the neck.