Cervical Sympathetic Block in Patients With Cerebral Vasospasm
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cervical sympathetic block.
- Who it may be relevant to
- Registry conditions: Anesthesia, Local, Cerebral Vasospasm, Subarachnoid Hemorrhage, Aneurysmal. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cervical Sympathetic Block to Increase Cerebral Blood Flow in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage
Overview
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.
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.
Interventions
- Procedure Cervical sympathetic block
All participants will get the cervical sympathetic block and catheter under ultrasound guidance.
Primary outcome measures
- Cerebral blood flow [Time frame: 1 hour after the block]
- Neurological function [Time frame: Duration of recovery in ICU (1-2 weeks)]
Secondary outcome measures (9)
- Cerebral blood flow velocity [Time frame: Daily during recovery in ICU (1-2 weeks)]
- Executive Functioning - Wisconsin Card Sorting Test (WCST) [Time frame: 12 months post-aSAH]
- Processing Speed - Symbol Digit Modalities Test (SDMT) [Time frame: 12 months post-aSAH]
- Language - Boston Naming Test (BNT) [Time frame: 12 months post-aSAH]
- Verbal Fluency - FAS Test [Time frame: 12 months post-aSAH]
- Memory - Hopkins Verbal Learning Test-Revised (HVLT-R) [Time frame: 12 months post-aSAH]
- General mental status - Montreal Cognitive Assessment (MoCA) [Time frame: 12 months post-aSAH]
- Functional disability - modified Rankin scale (mRS) [Time frame: 12 months post-aSAH]
- Health-Related Quality of Life (HRQoL, SF-36) [Time frame: 12 months post-aSAH]
Eligibility criteria
Inclusion criteria
- ages 18 and over
- patients hospitalized in the ICU and developing cerebral vasospasm after aneurysmal subarachnoid hemorrhage
Exclusion criteria
\- known advanced stage kidney disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Stanford University — Stanford
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. PMID 25128600
- Dagistan 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. PMID 31401069
- Treggiari 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. PMID 12649526
- Zhang 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. PMID 33472582
- Pileggi 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. PMID 33725155
Identifiers
NCT: NCT05230134 · 64105