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Search / Trial NCT07131696

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

Launched by MARSHALL HOLLAND · Aug 12, 2025

Trial Information

Current as of November 08, 2025

Not yet recruiting

Keywords

Cvs A Sah T Vns

ClinConnect Summary

This clinical trial is studying a new, non-invasive treatment called transcutaneous vagal nerve stimulation (tVNS) to help people who have had a type of brain bleed called aneurysmal subarachnoid hemorrhage (aSAH). After this type of bleeding, some patients develop a problem called cerebral vasospasm, where the brain’s blood vessels tighten and reduce blood flow, which can lead to strokes. Current treatments don’t always work well, so this study is testing whether using a small device that stimulates a nerve in the ear can help balance the nervous system, reduce inflammation, and prevent these blood vessel spasms.

Adults between 18 and 65 years old who have been diagnosed with a more severe form of this brain bleed (Fisher grade 3 or 4) and are able to have standard treatment for their aneurysm may be eligible to join. Participants will have the device placed on their ear to deliver gentle stimulation, which is already approved for other conditions like epilepsy and cluster headaches. The goal is to see if this treatment lowers the risk of complications from blood vessel spasms and improves recovery. If you or a loved one fits these criteria and are interested, this study may offer a promising new approach to support brain health after this serious type of stroke.

Gender

ALL

Eligibility criteria

  • 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

About Marshall Holland

Marshall Holland is a dedicated clinical trial sponsor committed to advancing medical research and innovation. With a focus on enhancing patient outcomes, the organization specializes in the design, implementation, and management of clinical trials across various therapeutic areas. Leveraging a team of experienced professionals and a robust network of clinical sites, Marshall Holland prioritizes adherence to regulatory standards and ethical practices. Their mission is to foster collaboration among stakeholders to expedite the development of safe and effective treatments, ultimately contributing to the improvement of global healthcare.

Locations

Birmingham, Alabama, United States

Patients applied

0 patients applied

Trial Officials

Marshall Holland, MD

Principal Investigator

University of Alabama at Birmingham

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported