Anesthesia, LocalNCT05230134
Cervical Sympathetic Block in Patients With Cerebral Vasospasm
A study testing Cervical sympathetic block in people with Anesthesia, Local and Cerebral Vasospasm, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local, Cerebral Vasospasm, Subarachnoid Hemorrhage, Aneurysmal
- What is being tested?
- Cervical sympathetic block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2023to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages 18 and over
- patients hospitalized in the ICU and developing cerebral vasospasm after aneurysmal subarachnoid hemorrhage
Who cannot join
- known advanced stage kidney disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Cervical Sympathetic Block to Increase Cerebral Blood Flow in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
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.
Read the detailed description
Patients hospitalized in the intensive care unit (ICU) and developing clinical manifestations of cerebral vasospasm will be transferred to the neuro-interventional radiology suite for vasospasm treatment. After the vasospasm is confirmed by the angiography followed by a flat panel-computed tomography perfusion (FP-CTP) scan, a cervical sympathetic nerve block under ultrasound guidance will be performed.
The block consists of the deposition of local anesthetic at the cervical sympathetic ganglion that will be visualized with an ultrasound device. The local anesthetic solution with be mixed with a radiographic contrast agent to check the spread of the injectate in the desired anatomical location. The spread of the local anesthetic will be assessed by performing an 8-second head/neck C-arm CT scan. Following the block, another run of angiography and a second FP-CTP will be repeated to assess changes in vessels diameter and in perfusion parameters following the sympathetic block.
Patients will have a daily monitoring of their neurological function and of their cerebral blood flow with transcranial doppler in the ICU.
At 12 months post-aSAH, the patients will complete neurological and neuropsychological assessments as a part of the standard of care. The results of these tests will be collected for analysis.
- Being tested
- Cervical sympathetic block
- Keywords
- regional anesthesia, cervical sympathectomy, cerebral blood flow
- Medical subject headings
- Vasospasm, Intracranial, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervical sympathetic blockProcedure or surgery
All participants will get the cervical sympathetic block and catheter under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Cervical sympathetic block | Experimental | Patients hospitalized in the ICU and developing clinical manifestations of cerebral vasospasm will be transferred to the neuro-interventional radiology suite for vasospasm treatment. After the vasospasm is confirmed by the angiography followed by a FP-CTP scan, 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. The spread of the local anesthetic will be assessed by performing an 8-second head/neck C-arm CT scan. Another run of angiography and a second FP-CTP 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. Receives: Procedure: Cervical sympathetic block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood flow
Cerebral blood flow as measured by computed tomography perfusion
Measured: 1 hour after the block
Neurological function
Change in neurological status as assessed by the Glasgow Coma Scale. The Glasgow Coma Scale score can range from 3 (completely unresponsive) to 15 (responsive).
Measured: Duration of recovery in ICU (1-2 weeks)
Secondary outcomes (9)
Cerebral blood flow velocity
Transcranial doppler measurement
Measured: Daily during recovery in ICU (1-2 weeks)
Executive Functioning - Wisconsin Card Sorting Test (WCST)
Measures executive functioning, including cognitive flexibility and problem-solving. The number of categories completed and total errors will be converted to age-adjusted z-scores.
Favorable outcome: z-score ≥ -1.0, unfavorable outcome: z-score < -1.0 (indicative of cognitive impairment in executive functioning).
Measured: 12 months post-aSAH
Processing Speed - Symbol Digit Modalities Test (SDMT)
Assesses visual scanning, tracking, and motor speed. Raw scores are adjusted for age and converted to z-scores. Favorable outcome: z-score ≥ -1.0, unfavorable outcome: z-score < -1.0
Measured: 12 months post-aSAH
Language - Boston Naming Test (BNT)
Evaluates confrontational word retrieval and naming ability. Scores are standardized using age norms. Favorable outcome: z-score ≥ -1.0, unfavorable outcome: z-score < -1.0
Measured: 12 months post-aSAH
Verbal Fluency - FAS Test
Tests lexical fluency by asking participants to generate words beginning with F, A, and S in a set time period. Z-scores are calculated from age-adjusted norms. Favorable outcome: z-score ≥ -1.0, unfavorable outcome: z-score < -1.0
Measured: 12 months post-aSAH
Memory - Hopkins Verbal Learning Test-Revised (HVLT-R)
Assesses verbal learning and memory, including immediate recall, delayed recall, and recognition. Performance is normed and converted into z-scores. Favorable outcome: z-score ≥ -1.0, unfavorable outcome: z-score < -1.0
Measured: 12 months post-aSAH
General mental status - Montreal Cognitive Assessment (MoCA)
Screens for mild cognitive impairment across multiple cognitive domains. Raw scores range from 0 to 30. Favorable outcome: MoCA score ≥ 26, unfavorable outcome: MoCA score < 26 (suggestive of cognitive impairment).
Measured: 12 months post-aSAH
Functional disability - modified Rankin scale (mRS)
Measurement of functional disability using mRS, categorized as favorable (0-3) or unfavorable (4-6), to assess long-term disability and its association with baseline perfusion.
Measured: 12 months post-aSAH
Health-Related Quality of Life (HRQoL, SF-36)
HRQoL will be reported as standardized z-scores, with higher scores indicating better performance.
Measured: 12 months post-aSAH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2022
- Study start27 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Maria Bombardieri, Stanford University
- Investigators
- Anna Maria Bombardieri, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05230134
- Sponsor's protocol ID
- 64105
- Status last verified
- Oct 2025
- First submitted
- 19 Jan 2022
- Last updated
- 20 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu N, Wu Y, Chen BZ, Han JF, Zhou MT. Protective effect of stellate ganglion block on delayed cerebral vasospasm in an experimental rat model of subarachnoid hemorrhage. Brain Res. 2014 Oct 17;1585:63-71. doi: 10.1016/j.brainres.2014.08.012. Epub 2014 Aug 13.
PubMed 25128600Dagistan Y, Kilinc E, Balci CN. Cervical sympathectomy modulates the neurogenic inflammatory neuropeptides following experimental subarachnoid hemorrhage in rats. Brain Res. 2019 Nov 1;1722:146366. doi: 10.1016/j.brainres.2019.146366. Epub 2019 Aug 8.
PubMed 31401069Treggiari MM, Romand JA, Martin JB, Reverdin A, Rufenacht DA, de Tribolet N. Cervical sympathetic block to reverse delayed ischemic neurological deficits after aneurysmal subarachnoid hemorrhage. Stroke. 2003 Apr;34(4):961-7. doi: 10.1161/01.STR.0000060893.72098.80. Epub 2003 Mar 20.
PubMed 12649526Zhang J, Nie Y, Pang Q, Zhang X, Wang Q, Tang J. Effects of stellate ganglion block on early brain injury in patients with subarachnoid hemorrhage: a randomised control trial. BMC Anesthesiol. 2021 Jan 20;21(1):23. doi: 10.1186/s12871-020-01215-3.
PubMed 33472582Pileggi M, Mosimann PJ, Isalberti M, Piechowiak EI, Merlani P, Reinert M, Cianfoni A. Stellate ganglion block combined with intra-arterial treatment: a "one-stop shop" for cerebral vasospasm after aneurysmal subarachnoid hemorrhage-a pilot study. Neuroradiology. 2021 Oct;63(10):1701-1708. doi: 10.1007/s00234-021-02689-9. Epub 2021 Mar 16.
PubMed 33725155