Cervical Sympathetic Block for Cerebral Vasospasm

Overseen By Anna Maria Bombardieri, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Advanced kidney disease

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

Compensation: Varies

Number of Visits: 1

Duration: 1-2 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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 vasospasm, after aneurysmal subarachnoid hemorrhage; 2) to evaluate the effect of the sympathetic block on the recovery of the neurological function.

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 data supports the effectiveness of the treatment Cervical Sympathetic Block for cerebral vasospasm?

Research suggests that Cervical Sympathetic Block (CSB) may help improve blood flow in the brain by temporarily blocking nerve signals that cause blood vessels to narrow, which can be beneficial for patients experiencing cerebral vasospasm after a brain hemorrhage. Studies have shown promising results, indicating that CSB could be a safe and effective complementary treatment to existing therapies for this condition. ^{1 2 3 4 5}

Is cervical sympathetic block generally safe for humans?

Cervical sympathetic block is considered a safe, minimally invasive procedure that can be performed at the bedside, with studies showing promising results for its use in treating cerebral vasospasm and delayed cerebral ischemia. However, further research is needed to standardize the technique and fully understand its long-term effects. ^{1 2 3 5 6}

How is the treatment Cervical Sympathetic Block different from other treatments for cerebral vasospasm?

Cervical Sympathetic Block is unique because it involves injecting a local anesthetic to temporarily block nerve signals in the neck, leading to the widening of blood vessels in the brain. This minimally invasive and low-cost treatment can be performed at the bedside, offering a potential advantage over more complex procedures like balloon angioplasty or stenting. ^{1 2 3 6 7}

Research Team

Anna Maria Bombardieri, MD, PhD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

Group I: Cervical sympathetic block Experimental Treatment 1 Intervention

Patients hospitalized in the ICU and developing clinical manifestations of cerebral vasospasm will undergo a computerized tomography (CT) angiography and a CT perfusion scan. If the vasospasm will be confirmed by the CT imaging, a cervical sympathetic nerve block under ultrasound guidance will be performed. The block consists in the deposition of local anesthetic at the cervical sympathetic ganglion that will be visualized with an ultrasound device. A periganglionar catheter will be left in place. A CT angiography and CT perfusion will be repeated to check the effect of the block on the brain vasculature after the block is done. Patients will have a daily monitoring of their neurological function and of their cerebral blood flow with transcranial doppler in the ICU.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Cervical sympathetic block to reverse delayed ischemic neurological deficits after aneurysmal subarachnoid hemorrhage. [2016]

2. Brazil pubmed.ncbi.nlm.nih.gov

Effect of cervical sympathetic block on cerebral vasospasm after subarachnoid hemorrhage in rabbits. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Percutaneous cervical sympathetic block to treat cerebral vasospasm and delayed cerebral ischemia: a review of the evidence. [2023]

4. India pubmed.ncbi.nlm.nih.gov

Impact of Stellate Ganglion Block in the Management of Cerebral Vasospasm: A Prospective Interventional Study. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Stellate Ganglion Block in Subarachnoid Hemorrhage: A Promising Protective Measure against Vasospasm? [2023]

6. England pubmed.ncbi.nlm.nih.gov

Novel endovascular transmural technique for pharmacological block of superior cervical ganglion prevents sympathetic-mediated cerebral vasospasm. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Cervical Ganglion Sympathectomy to Treat Cerebral Vasospasm in Subarachnoid Hemorrhage. [2023]