Spinal Cord Stimulation for Cerebral Vasospasm

Overseen By Jesse Jones, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Medically unfit, Posterior circulation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on adding a procedure to existing therapy, so you might be able to continue your current medications, but it's best to confirm with the trial coordinators.

What data supports the effectiveness of the treatment Spinal Cord Stimulation for Cerebral Vasospasm?

Research shows that cervical spinal cord stimulation (cSCS) can increase blood flow in the brain and may help prevent and treat cerebral vasospasm (narrowing of blood vessels in the brain) after a type of brain bleed called aneurysmal subarachnoid hemorrhage. Studies have found that cSCS is safe and feasible, with some patients showing improved consciousness and reduced vasospasm. ^{1 2 3 4 5}

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS), including cervical spinal cord stimulation (cSCS) and transcutaneous spinal cord stimulation (tSCS), has been shown to be relatively safe in humans. Studies report low rates of complications, with one study showing no long-term side effects over a year and another reporting a 0.5% rate of spinal cord injury. Overall, SCS is considered a safe treatment option for various conditions. ^{1 2 5 6 7}

How does spinal cord stimulation differ from other treatments for cerebral vasospasm?

Spinal cord stimulation (SCS) is unique because it uses electrical impulses to improve blood flow and reduce vasospasm (narrowing of blood vessels) in the brain, which is not a feature of traditional drug treatments. Unlike medications, SCS is a non-drug therapy that directly targets the spinal cord to influence blood circulation, offering a novel approach for conditions like cerebral vasospasm where effective treatments are limited. ^{1 2 3 4 8}

Research Team

Jesse Jones, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

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.

Inclusion Criteria

Provision of signed and dated informed consent form

Stated willingness to comply with all study procedures and availability for the duration of the study

I have been diagnosed with a severe brain hemorrhage.

Exclusion Criteria

I had a bleeding in the brain from an aneurysm in the back part of my brain.

My aneurysm treatment started after the first day of bleeding.

Does not provide consent for the procedure

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spinal cord stimulation or a sham procedure to assess its effect on cerebral vasospasm over a 14-day period

2 weeks

Daily visits for transcranial Doppler studies

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Overall survival and long-term outcomes are assessed

Approximately 24 months

Treatment Details

Interventions

• Spinal Cord Stimulation

Trial Overview 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.

Participant Groups

Group I: Spinal Cord Stimulation Experimental Treatment 1 Intervention

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

Group II: Sham Comparator Placebo Group 1 Intervention

Participants randomized to not receive temporary electrode.

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

Transcutaneous spinal cord stimulation (tSCS) shows potential for generating motor activity in individuals with spinal cord injury, but the overall quality of the studies reviewed was poor-to-fair, indicating a need for more rigorous research.

The review identified significant variability in stimulation parameters and outcome measurements across the 25 studies analyzed, highlighting the necessity for standardized methods to improve the reliability and comparability of tSCS research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. Taylor, C., McHugh, C., Mockler, D., et al.[2022]

In a study of 68 patients who had spinal cord stimulation paddle electrodes removed, the most common reason for removal was loss of coverage or effect (75%), indicating that while SCS is effective, it may not always provide lasting relief.

Postoperative complications occurred in 11.75% of patients, with two major complications requiring reoperation, highlighting that while SCS removal is generally safe, it does carry some risks that patients should be aware of.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. Maldonado-Naranjo, AL., Frizon, LA., Sabharwal, NC., et al.[2022]

In a study analyzing 2053 cases of cervical spinal cord stimulation (cSCS) from 2002 to 2011, the rate of spinal cord injury was found to be 0.5%, which is higher than previously reported, indicating a need for careful patient selection and counseling.

Despite the spinal cord injury rate, cSCS remains a relatively safe procedure with low rates of other complications (1.1% neurological, 1.4% medical, and 11.7% general perioperative complications), making it a viable option for pain management in patients, especially in an aging population reliant on opioids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. Chan, AK., Winkler, EA., Jacques, L.[2017]

References

1. Austria pubmed.ncbi.nlm.nih.gov

Cervical spinal cord stimulation for prevention and treatment of cerebral vasospasm after aneurysmal subarachnoid hemorrhage: clinical and radiographic outcomes of a prospective single-center clinical pilot study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Beneficial effects of cervical spinal cord stimulation (cSCS) on patients with impaired consciousness: a preliminary report. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of electrical stimulation of the cervical spinal cord on blood flow following subarachnoid hemorrhage. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Use of cervical spinal cord stimulation in treatment and prevention of arterial vasospasm after aneurysmal subarachnoid hemorrhage. Technical details. [2017]

6. United States pubmed.ncbi.nlm.nih.gov

Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation. [2017]

8. United States pubmed.ncbi.nlm.nih.gov

Preemptive spinal cord stimulation reduces ischemia in an animal model of vasospasm. [2019]