The Effect of Transcutaneous Vagal Nerve Stimulation (tVNS) on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage

Purpose

The significance of developing a safe and effective therapy for aneurysmal subarachnoid hemorrhage (aSAH) patients suffering cerebral vasospasm (CVS) cannot be overstated. Vasospasm - a clamping down of normal arteries in the days following rupture - remains incredibly challenging to treat.1,2 Current drugs and minimally invasive surgical therapies are helpful, yet woefully insufficient. Symptomatic cerebral vasospasm afflicts about 30% of aneurysmal subarachnoid hemorrhage patients and nearly half will go on to suffer a stroke, despite aggressive medical care.1-3 The autonomic nervous system is a balance between sympathetic (fight or flight) and parasympathetic (rest and digest) influence with sympathetic overactivity and inflammation shown to play an important role in the development and severity of cerebral vasospasm.4,5,17-20 Prior studies of autonomic nervous system neuromodulation highlight its promise as a promising potential avenue to improve morbidity and mortality from CVS in aSAH.6-15 Despite progress, continued high levels of CVS morbidity and mortality stress the urgent need for exploration of neuromodulation therapy. In this proposal, the study team will modulate the autonomic nervous system function in aSAH patients using transcutaneous vagal nerve stimulation (tVNS). tVNS involves placement of a stimulation electrode on the external ear to non-invasively stimulate a branch of the vagal nerve and increase parasympathetic influence. This device has FDA approval for epilepsy and cluster headache. The study hypothesis is that neuromodulation of the autonomic nervous system with tVNS (increasing parasympathetic influence) reduces sympathetic overactivity and inflammation in aSAH resulting in decreased morbidity of CVS.

Conditions

  • Aneurysmal Subarachnoid Hemorrhage
  • Vasospasm, Cerebral
  • Transcutaneous Vagal Nerve Stimulation (tVNS)
  • Endovascular Treatment

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Provision of signed and dated informed consent - Stated willingness to comply with all study procedures and availability for the duration of the study - Male or Female - 18-65 years of age - Diagnosed with Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage - Ability to undergo endovascular treatment of aneurysmal subarachnoid hemorrhage - For females of reproductive potential: negative pregnancy test at time of treatment. - Plan to undergo standard of care treatment and follow-up

Exclusion Criteria

  • Medically unfit to undergo endovascular treatment (e.g., Hunt Hess grade 5) - Does not provide consent - Posterior circulation aneurysmal subarachnoid hemorrhage - Initial aneurysm treatment after post bleed day 1

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
tVNS
  • Device: Transcutaneous Vagal Nerve Stimulation
    Participants will receive up to 4 sessions per day of up to 20-minute stimulation, over the next 10 days of their inpatient hospital stay, following endovascular treatment. Stimulation will be provided by the tVNS device through a small electrode placed around the ear that will send low intensity, pulsed, electrical pulses the vagus nerve.
    Other names:
    • tVNS

Recruiting Locations

UAB Hospital
Birmingham, Alabama 35233
Contact:
Marshall Holland Assistant Professor of Neurosurgery

More Details

Status
Recruiting
Sponsor
Marshall Holland

Study Contact

Marshall Holland, MD
2059343411
mtholland@uabmc.edu