The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage

NCT06443177 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: IRB-300012920UAB
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to see that in addition to existing therapy, how well an additional procedure named spinal cord stimulation might reduce blood vessel spasm from aneurysm rupture.

Conditions

Vasospasm, Cerebral; Aneurysmal Subarachnoid Hemorrhage

Keywords

aSAH; CVS; Sympathetic Modulation; Ruptured brain aneurysm

Outcome Measures

Primary Outcomes (7)

• Pre-Cerebrovascular response - Velocity

  Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.

  Day 1 - Day 14

• Pre-Cerebrovascular response - Resistance

  Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.

  Day 1 - Day 14

• Pre-Cerebrovascular response - Lindegaard ratio

  Pre-SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.

  Day 1 - Day 14

• Post-Cerebrovascular response - Velocity

  Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.

  Day 1 - Day 14

• Post-Cerebrovascular response - Resistance

  Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.

  Day 1 - Day 14

• Post-Cerebrovascular response - Lindegaard ratio

  Post SCS measures of cerebral blood flow. Subjects will serve as their own internal control (on vs off stimulation) and be grouped collectively to enable more robust statistical analysis. To study the effect of SCS on cerebrovascular tone longitudinally over the course of the vasospasm window, mixed model statistics will be applied.

  Day 1 - Day 14

• Transcranial Doppler (TCD) velocities of cerebral arteries

  Daily transcranial Doppler studies will be performed to obtain quantitative data on cerebrovascular response during the critical 14-day vasospasm window.

  Day 1 - Day 14

Secondary Outcomes (1)

• Overall Survival

  Through study completion, approximately 24 months

Study Arms (2)

Spinal Cord Stimulation

EXPERIMENTAL

Participants randomized to receive temporary electrode inserted through the skin into the epidural space of participants upper back/lower neck.

Device: Vectris trial leads and stimulation

Sham Comparator

SHAM COMPARATOR

Participants randomized to not receive temporary electrode.

Device: Sham

Interventions

Vectris trial leads and stimulation DEVICE

The electrode is placed into the epidural space using standard epidural placement techniques with paramedian approach. The initial electrode settings have been adopted from prior studies. Should any significant discomfort be elicited from the stimulation, first the amplitude will be decreased to an acceptable level. If an acceptable level of stimulation is unable to be found, the stimulation will be discontinued.

Spinal Cord Stimulation

Sham DEVICE

No electrode is placed.

Sham Comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Diagnosed with Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage (1)
• Ability to undergo endovascular treatment of aneurysmal subarachnoid hemorrhage
• For females of reproductive potential: Negative pregnancy test at time of treatment
• Plan to undergo standard of care and follow-up

You may not qualify if:

• Medically unfit to undergo endovascular treatment (e.g., Hunt Hess grade 5)
• Does not provide consent for the procedure.
• Posterior circulation aneurysmal subarachnoid hemorrhage.
• Initial aneurysm treatment after post bleed day 1

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Vasospasm, Intracranial; Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jesse Jones, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jesse Jones, MD

CONTACT

205-934-7170; jessejones@uabmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: June 5, 2024
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)