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Enrolling by Invitation

NCT Number: NCT05230134

Cervical Sympathetic Block in Patients With Cerebral Vasospasm

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.

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Key information

Conditions

Anesthesia, Local Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Vasospasm Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Subarachnoid Hemorrhage, Aneurysmal Vascular Diseases Vasospasm, Intracranial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cervical sympathetic block

Procedure

All participants will get the cervical sympathetic block and catheter under ultrasound guidance.

Primary outcomes

  1. Cerebral blood flow

    Time frame: 1 hour after the block

    Cerebral blood flow as measured by computed tomography perfusion

  2. Neurological function

    Time frame: 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 outcomes

  1. Cerebral blood flow velocity

    Time frame: Daily during recovery in ICU (1-2 weeks)

    Transcranial doppler measurement

  2. Executive Functioning - Wisconsin Card Sorting Test (WCST)

    Time frame: 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).

  3. Processing Speed - Symbol Digit Modalities Test (SDMT)

    Time frame: 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

  4. Language - Boston Naming Test (BNT)

    Time frame: 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

  5. Verbal Fluency - FAS Test

    Time frame: 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

  6. Memory - Hopkins Verbal Learning Test-Revised (HVLT-R)

    Time frame: 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

  7. General mental status - Montreal Cognitive Assessment (MoCA)

    Time frame: 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).

  8. Functional disability - modified Rankin scale (mRS)

    Time frame: 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.

  9. Health-Related Quality of Life (HRQoL, SF-36)

    Time frame: 12 months post-aSAH

    HRQoL will be reported as standardized z-scores, with higher scores indicating better performance.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

Cervical Sympathetic Block to Increase Cerebral Blood Flow in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 8, 2022
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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