Cervical Sympathetic Block in Patients With Cerebral Vasospasm

Not Applicable

• Conditions: Anesthesia, Local; Cerebral Vasospasm; Subarachnoid Hemorrhage, Aneurysmal

• Registration Number: NCT05230134
• Lead Sponsor: Stanford University

Brief 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.

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.

Study Timeline

• Study First Submitted: 2022-01-19
• Study First Submitted QC: 2022-02-07
• Study First Posted: 2022-02-08
• Study Start: 2023-07-27
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-14
• Last Update Posted: 2025-10-20
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cerebral blood flow	1 hour after the block	Cerebral blood flow as measured by computed tomography perfusion
Neurological function	Duration of recovery in ICU (1-2 weeks)	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).

Secondary Outcome Measures

Name	Time	Method
Cerebral blood flow velocity	Daily during recovery in ICU (1-2 weeks)	Transcranial doppler measurement
Processing Speed - Symbol Digit Modalities Test (SDMT)	12 months post-aSAH	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
Language - Boston Naming Test (BNT)	12 months post-aSAH	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
Verbal Fluency - FAS Test	12 months post-aSAH	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
Executive Functioning - Wisconsin Card Sorting Test (WCST)	12 months post-aSAH	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).
Memory - Hopkins Verbal Learning Test-Revised (HVLT-R)	12 months post-aSAH	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
General mental status - Montreal Cognitive Assessment (MoCA)	12 months post-aSAH	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).
Functional disability - modified Rankin scale (mRS)	12 months post-aSAH	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.
Health-Related Quality of Life (HRQoL, SF-36)	12 months post-aSAH	HRQoL will be reported as standardized z-scores, with higher scores indicating better performance.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States