Cervical Sympathetic Block for Cerebral Vasospasm

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AM
Overseen ByAnna Maria Bombardieri, MD, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether a cervical sympathetic block (a procedure using local anesthesia to block nerves in the neck) can improve blood flow to the brain and aid recovery in patients with cerebral vasospasm. Cerebral vasospasm occurs when blood vessels in the brain narrow, often following a type of stroke called a subarachnoid hemorrhage. The treatment could potentially assist those in the ICU facing this specific issue. Ideal candidates are patients who have developed cerebral vasospasm after an aneurysm-related brain bleed and are currently hospitalized in an ICU. As an unphased trial, this study provides a unique opportunity to contribute to medical research and potentially benefit from an innovative treatment approach.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this cervical sympathetic block is safe for treating cerebral vasospasm?

Research has shown that the cervical sympathetic block is generally well-tolerated in patients with brain blood vessel spasms. In one study, patients improved their neurological scores shortly after the procedure, suggesting it might be safe and helpful. Another study found that this treatment could prevent further issues by calming the sympathetic nerves. However, like any procedure, risks exist. Some patients experienced severe outcomes, but these resulted from their initial condition, not the treatment itself. Overall, the cervical sympathetic block has been used successfully in similar cases, indicating it is reasonably safe for those considering joining a trial.12345

Why are researchers excited about this trial?

Unlike the standard treatments for cerebral vasospasm, which often include oral nimodipine and endovascular interventions like angioplasty or intra-arterial vasodilators, the cervical sympathetic block offers a unique approach. This treatment involves applying a local anesthetic directly to the cervical sympathetic ganglion, guided by ultrasound, which could result in more precise targeting and potentially fewer systemic effects. Researchers are excited about this technique because it allows for real-time monitoring of blood flow changes in the brain, using advanced imaging methods like angiography and CT scans, to assess its immediate impact. This could lead to faster and possibly more effective management of vasospasm symptoms in critically ill patients.

What evidence suggests that a cervical sympathetic block is effective for cerebral vasospasm?

Research has shown that a procedure called cervical sympathetic block (CSB), which participants in this trial will receive, might help treat cerebral vasospasm. This condition occurs when blood vessels in the brain narrow after a bleed, such as from an aneurysm. Studies suggest that CSB can help these blood vessels widen, improving blood flow. Tests using Transcranial Doppler found that blood flow speed decreases by about 15%, indicating that the vessels are opening up. Other research has shown that blocking certain nerves can reduce the severity of vasospasm symptoms. While this treatment isn't commonly used yet, early evidence suggests it could aid in recovery and improve blood flow in the brain.25678

Who Is on the Research Team?

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Anna Maria Bombardieri, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are in the ICU with cerebral vasospasm following a brain aneurysm bleed. It's not suitable for those with advanced kidney disease.

Inclusion Criteria

I am in the ICU due to brain vessel spasms after a brain bleed from an aneurysm.

Exclusion Criteria

My kidney disease is in an advanced stage.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Cervical sympathetic nerve block performed under ultrasound guidance with daily monitoring of neurological function and cerebral blood flow

1-2 weeks
Daily monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cervical Sympathetic Block
Trial Overview The study tests whether a cervical sympathetic block, which is an injection near the neck to interrupt nerve signals, can improve blood flow in the brain and neurological recovery after a subarachnoid hemorrhage.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Cervical sympathetic blockExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Citations

Percutaneous cervical sympathetic block to treat cerebral ...Evidence that CSB is effective in treating vasospasm. Experimental models of aSAH demonstrated that CSB results in vasodilatation due to a reduction in ...
Cervical Sympathetic Block in Patients With Cerebral ...The purposes of this study are twofold: 1) to assess the effect of a cervical sympathetic block on cerebral blood flow in patients suffering from cerebral ...
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36424089/
Cervical sympathectomy to treat cerebral vasospasmTranscranial Doppler studies found an approximately 15% statistically significant decrease in velocities consistent with arterial vasodilatation ...
Sympathetic nerve block as an add-on therapy for ...Several studies have shown that sympathetic nerve block helps reduce the severity of vasospasm (97, 98).
5.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/36597947/
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.
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 ...
Cervical Sympathetic Block to Reverse Delayed Ischemic ...One patient died of the complications of the initial hemorrhage, and 2 died of the consequences of the severe vasospasm despite maximal medical treatment. In ...
Sympathetic nerve block as an add-on therapy for intervention ...Stellate ganglion block (SGB) has been reported to have a protective effect in patients at risk for vasospasm after SAH due to reduced sympathetic activity.
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