N/A
N=40
Safety and Efficacy of Non-invasive Vagus Nerve Stimulation in the Treatment of Headache in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal
Bottom Line
View on ClinicalTrials.gov: NCT04126408 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: The Difference Between the Active and Sham Treatment Groups in Morphine Equivalence Dosage PER DAY — 0.058; 0.24 mg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- gammaCore (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwell Health
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Difference Between the Active and Sham Treatment Groups in Morphine Equivalence Dosage PER DAY |
0.058; 0.24 | — |
| PRIMARY Overall Difference in MED at 7 Days |
21.99; 24.29 | — |
| SECONDARY The Difference Between the Active and Sham Treatment Groups in the Mean Daily Headache Intensity Pre and Post Stimulation |
-0.59; -0.13 | — |
| SECONDARY The Difference in Device Related Heart Rate Change Before and After Stimulation |
-1.73; -0.76 | — |
| SECONDARY Change in SBP Between Active and Sham Group |
-2.20; -1.64 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04126408). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.