Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04126408
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04126408
Study Brief:
Protocol Section:
NCT04126408