Vagal Nerve Stimulation + Cervical Sympathetic Block for Brain Aneurysm
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how two treatments—a cervical sympathetic block (an injection in the neck) and vagal nerve stimulation (a mild electrical therapy on the ear)—might aid patients with subarachnoid hemorrhage, a type of brain bleed. Researchers aim to determine if these treatments can enhance blood flow in the brain and aid recovery. The trial seeks patients admitted to the intensive care unit with a confirmed brain bleed who are willing to participate in monitoring and treatment sessions. As an unphased trial, this study offers patients the chance to contribute to groundbreaking research that could lead to new treatment options.
Do I need to stop taking my current medications for the trial?
The trial requires that you do not use Class I or III antiarrhythmic medications. If you are on these medications, you may need to stop them to participate.
What prior data suggests that the cervical sympathetic block and vagal nerve stimulation are safe for brain aneurysm patients?
Research shows that both treatments tested in this trial, cervical sympathetic block (CSB) and transcutaneous auricular vagal nerve stimulation (taVNS), are generally safe. Studies have found that cervical sympathetic block is effective with few side effects. This low-cost, minimally invasive procedure can be performed at the bedside. Patients with brain blood vessel spasms have shown improvements after receiving it.
Similarly, research on transcutaneous auricular vagal nerve stimulation indicates it is also safe, with most side effects being mild and temporary. Importantly, studies have found no serious heart-related issues, such as irregular heartbeats, associated with taVNS. Overall, previous studies have shown both treatments to be well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel approach to managing brain aneurysms using a combination of techniques. Unlike traditional treatments that focus primarily on surgical intervention or medication, this protocol involves autonomic modulation through right-sided cervical sympathetic block (CSB) and transcutaneous auricular vagal nerve stimulation (taVNS). The CSB is guided by ultrasound at the C6 level, providing a targeted blockade, while taVNS is delivered non-invasively to the cymba conchae of the ear, using TENS technology. This combination aims to modulate the autonomic nervous system, potentially offering a new way to stabilize cerebral blood flow and reduce complications in patients with brain aneurysms. Researchers are keen to see if this technique can offer faster or more stable results compared to standard care options.
What evidence suggests that this trial's treatments could be effective for brain aneurysm?
This trial will evaluate the effects of autonomic modulation using a cervical sympathetic block (CSB) and transcutaneous auricular vagal nerve stimulation (taVNS) for patients with brain aneurysms. Studies have shown that a cervical sympathetic block can improve blood flow in the brain after a subarachnoid hemorrhage, a type of stroke. This procedure can reduce the severity of blood vessel spasms, leading to better recovery of brain function. Research indicates that patients often notice immediate improvement in their condition.
Research also suggests that transcutaneous auricular vagal nerve stimulation can help manage artery spasms in the brain after an aneurysm. This non-invasive treatment may lower the risk of the aneurysm bursting and aid in recovery. It is generally considered safe and has shown positive results in several studies. Participants in this trial will receive both CSB and taVNS as part of the autonomic modulation component.12346Who Is on the Research Team?
Noah Jouett, DO, PhD
Principal Investigator
University of Texas Southwestern Medical Center
Are You a Good Fit for This Trial?
This trial is for adults who have had a brain aneurysm that caused bleeding (aneurysmal subarachnoid hemorrhage) and are being treated in the neuroscience ICU at UT Southwestern Medical Center.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Component 1: CA Monitoring and EVD Clamping Validation
Validation of noninvasive cerebral autoregulation indices against invasive equivalents and characterization of CA parameter evolution through ICU Day 14
Component 2: Autonomic Modulation
Assessment of the effects of cervical sympathetic block and transcutaneous auricular vagal nerve stimulation on cerebral autoregulation parameters
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Right-Sided Cervical Sympathetic Block at C6
- Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)
Trial Overview
The study tests two things: first, it checks if a new noninvasive device can accurately monitor brain pressure compared to standard invasive methods; second, it examines how nerve stimulation treatments affect brain blood flow regulation after an aneurysm bleed.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Component 1 participants meeting Component 2 eligibility criteria after PI readiness declaration. Receive right-sided cervical sympathetic block (CSB; ultrasound-guided, C6) and transcutaneous auricular vagal nerve stimulation (taVNS; cymba conchae, TENS 7000; twice daily 20-minute sessions for up to 14 days). Within-subject before-after assessment of CA parameter effects. CA monitoring from Component 1 continues throughout.
All enrolled aSAH patients. Multimodal CA monitoring (B4C extensometry, NIRS-derived indices, invasive ICP/CPP from EVD where present) throughout ICU Days 1-14. Participants with open EVDs additionally undergo a standardized 15-minute EVD clamping sub-protocol for simultaneous invasive/noninvasive CA index validation, up to one session per 24-hour period. No interventional procedures administered under Component 1.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
Citations
Percutaneous cervical sympathetic block to treat cerebral ...
Several single arm studies suggest that CSB leads to an immediate improvement in neurologic status and favorable rates of long-term clinical outcomes. Treggiari ...
Percutaneous cervical sympathetic block to treat cerebral ...
A simple treatment such as a cervical sympathetic block (CSB) may be an effective therapy but is not routinely performed to treat vasospasm/DCI.
Sympathetic nerve block as an add-on therapy for ...
In cerebral vasospasm, particularly following SAH, SGB can potentially reduce the severity of vasospasm, alleviate ischemia, and improve neurological outcomes.
Cervical Sympathetic Block to Reverse Delayed Ischemic ...
Conclusions— Patients with mild to moderate symptoms seem to benefit greatly from transient ipsilateral cervical sympathetic block. This simple technique may be ...
Safety Study of Cervical Sympathetic Block for Cerebral ...
To evaluate the feasibility of performing a cervical sympathetic block in patients with severe cerebral vasospasm involving the anterior cerebral circulation ...
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dukespace.lib.duke.edu
dukespace.lib.duke.edu/server/api/core/bitstreams/e422e629-8b6c-406e-87fc-49a8b7e3d5f9/contentCervical sympathectomy to treat cerebral vasospasm
The lack of robust validating data and the low safety profile of this intervention might have contributed to its lack of adoption. Previously, ...
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