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Spinal Cord Stimulation for Cerebral Vasospasm

N/A
Waitlist Available
Led By Jesse Jones, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage
Ability to undergo endovascular treatment of aneurysmal subarachnoid hemorrhage
Must not have
Posterior circulation aneurysmal subarachnoid hemorrhage
Initial aneurysm treatment after post bleed day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, approximately 24 months

Summary

This trial aims to investigate if adding a procedure called spinal cord stimulation to the current treatment can help reduce blood vessel spasms caused by a ruptured aneurysm.

Who is the study for?
This trial is for adults who've had a specific type of brain bleed (Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage) and can have endovascular treatment. They must consent to all study procedures, be available throughout the study, and women must not be pregnant. It's not for those with posterior circulation bleeds, treated after day 1 of bleeding, unwilling to consent, or too ill for the procedure.
What is being tested?
The trial tests if spinal cord stimulation (Vectris leads and stimulation), along with standard care, helps reduce blood vessel spasms in the brain following an aneurysm rupture compared to a sham (fake) procedure.
What are the potential side effects?
While specific side effects are not listed here, spinal cord stimulation may include discomfort at the implant site, unwanted tingling sensations due to electrical impulses or infection risks associated with any surgical intervention.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with a severe brain hemorrhage.
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I can have a procedure for my brain aneurysm bleeding.
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I am not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had a bleeding in the brain from an aneurysm in the back part of my brain.
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My aneurysm treatment started after the first day of bleeding.
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I am considered medically unfit for certain blood vessel procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, approximately 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, approximately 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-Cerebrovascular response - Lindegaard ratio
Post-Cerebrovascular response - Resistance
Post-Cerebrovascular response - Velocity
+4 more
Secondary study objectives
Overall Survival

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Spinal Cord StimulationExperimental Treatment1 Intervention
Participants randomized to receive temporary electrode inserted through the skin into the epidural space of participants upper back/lower neck.
Group II: Sham ComparatorPlacebo Group1 Intervention
Participants randomized to not receive temporary electrode.

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,748 Total Patients Enrolled
Jesse Jones, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
1 Previous Clinical Trials
48 Total Patients Enrolled
~17 spots leftby Mar 2026
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