Status:
COMPLETED
Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage
Lead Sponsor:
Northwell Health
Conditions:
Subarachnoid Hemorrhage, Aneurysmal
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 ...
Detailed Description
This is a single site, randomized, sham-controlled, double-blind study assessing the feasibility, safety, tolerability, and efficacy of non-invasive VNS (nVNS) in the treatment of headache in subarach...
Eligibility Criteria
Inclusion
- Established signed and dated informed consent form
- CT of the head revealing blood in the subarachnoid space
- Subject is male or female, 18 to 80 years of age
- Subject alert to be able to verbalize pain level. If alertness improves after placement of an external ventricular drain, or once extubated, and the patient becomes alert , the patient will be enrolled
- Subject reports pain of \> =7 on 10 Point Pain numeric rating scale
- Female of reproductive age must have a negative pregnancy test (Urine or blood test)
Exclusion
- Use of any concomitant electrostimulation devices (Pacemaker, defibrillator, deep brain stimulation.)
- Unsecured aneurysm defined as aneurysm that has not been surgically or endovascularly treated.
- Previous carotid surgeries or known history of carotid artery disease
- Screws, metals or device in the neck
- History of secondary or tertiary heart blocks, ventricular tachycardia, Supra-Ventricular Tachycardia (including atrial fibrillation)
- Alcoholics (CAGE scale of 2 or greater). If patients are on Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol for alcohol withdrawal, the patient will be excluded from the study.
- Drug addicts or chronic opioid users confirmed by history or with urine toxicology showing opiates or cocaine
- small traumatic SAH
Key Trial Info
Start Date :
January 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04126408
Start Date
January 13 2020
End Date
June 20 2022
Last Update
January 9 2024
Active Locations (1)
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1
Northshore University Hospital
Manhasset, New York, United States, 11030