Transcutaneous Vagal Nerve Stimulation for Cerebral Vasospasm

Overseen By Marshall Holland, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Marshall Holland

Disqualifiers: Medically unfit, Posterior circulation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to assist individuals with cerebral vasospasm, a serious condition that can occur after a brain aneurysm bursts. The treatment, Transcutaneous Vagal Nerve Stimulation, uses a device to gently stimulate a nerve in the ear, calming the body's stress response. Researchers aim to reduce complications and improve recovery following the aneurysm. Patients who have experienced a specific type of brain hemorrhage and can undergo a certain treatment might be suitable candidates.

As an unphased trial, this study provides patients the opportunity to contribute to groundbreaking research that could lead to new treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this device is safe for use in cerebral vasospasm patients?

Research shows that transcutaneous vagal nerve stimulation (tVNS) is generally safe for people. Studies have found that tVNS does not cause major heart problems, such as a very slow heartbeat or heart rhythm issues, making it a promising area for further research.

Additionally, the FDA has approved tVNS for treating epilepsy and cluster headaches, indicating it is well-tolerated for other conditions. Although not specifically approved for cerebral vasospasm, this background supports its safety.

Overall, tVNS appears to be a safe and non-invasive method for managing symptoms related to cerebral vasospasm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcutaneous Vagal Nerve Stimulation (tVNS) is unique because it offers a non-invasive approach to treating cerebral vasospasm, a condition typically managed with medications like calcium channel blockers or endovascular procedures. Unlike these standard treatments, tVNS uses electrical stimulation applied through the skin to influence the vagus nerve, potentially improving blood flow in the brain without the need for surgery or systemic drugs. Researchers are excited about this approach because it could minimize side effects and offer a more accessible and convenient treatment option for patients.

What evidence suggests that transcutaneous vagal nerve stimulation is effective for cerebral vasospasm?

This trial will explore the potential of transcutaneous vagus nerve stimulation (tVNS) to aid in cerebral vasospasm (CVS) by reducing inflammation and improving blood flow. Studies have shown that patients using tVNS achieved better outcomes, with more favorable results at both discharge and follow-up compared to those who did not receive it. Evidence from animal studies suggests that tVNS might reduce stroke size, a risk associated with CVS. Although tVNS is already approved for conditions like epilepsy and cluster headaches, its potential to help with CVS is promising and merits further exploration in this trial. ^{1 2 4 6 7}

Who Is on the Research Team?

Marshall Holland, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for patients who have had a brain aneurysm and are experiencing cerebral vasospasm, which can lead to stroke. Participants should be those affected by conditions like migraine or cerebral vasoconstriction syndrome and must not have received certain other treatments.

Inclusion Criteria

I am either male or female.

Provision of signed and dated informed consent

I plan to follow the recommended treatment and check-ups.

Exclusion Criteria

I am considered medically unfit for certain blood vessel procedures.

Does not provide consent

I have had a bleeding in the brain from an aneurysm in the back part of my brain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcutaneous vagal nerve stimulation (tVNS) to modulate autonomic nervous system function

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Vagal Nerve Stimulation

Trial Overview The study tests if stimulating the vagal nerve through the skin (tVNS) can help control artery spasms in the brain after an aneurysm. It's non-invasive, using a device on the ear approved for epilepsy and cluster headaches, aiming to balance nervous system activity.

How Is the Trial Designed?

Group I: tVNS Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Marshall Holland

Lead Sponsor

Trials

1

Recruited

20+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11363710/

Transcutaneous vagus nerve stimulation: a bibliometric study ... These findings suggest that tVNS may promote angiogenesis and neurogenesis, and modulate neuroplasticity, thereby alleviating vascular and neurological ...

2. thejns.org thejns.org/view/journals/j-neurosurg/142/6/article-p1720.xml

Auricular vagus nerve stimulation for mitigation of ... Patients receiving taVNS had higher rates of favorable outcomes at discharge (38.4% vs 21.4%) and first follow-up (76.9% vs 57.1%). Patients ...

3. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.123.043414

tVNS in Stroke: A Narrative Review on the Current State ... Transcutaneous vagus nerve stimulation (tVNS) has shown promising evidence as a tool to reduce infarct size in animal models of hyperacute stroke.

4. elifesciences.org elifesciences.org/reviewed-preprints/100088v1/pdf

The effect of transcutaneous auricular vagus nerve ... We found that repetitive taVNS did not significantly alter heart rate, corrected QT interval, blood pressure, or intracranial pressure. However, taVNS increased ...

5. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/93/NCT06374693/Prot_000.pdf

Investigating the tolerability and feasibility of ... Noninvasive Vagus Nerve Stimulation. Prevents Ruptures and Improves Outcomes in a Model of Intracranial Aneurysm in. Mice. Stroke. May 2019;50(5): ...

6. elifesciences.org elifesciences.org/reviewed-preprints/100088

The effect of transcutaneous auricular vagus nerve ... Our study found that taVNS treatment did not induce adverse cardiovascular effects, such as bradycardia or QT prolongation, supporting its development as a ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1053811925004999

Investigating the effects of transcutaneous Vagus Nerve ... A novel transcutaneous vagus nerve stimulation leads to brainstem and cerebral activations measured by functional MRI /Funktionelle ...