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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding spinal cord stimulation, a technique using electrical impulses, can reduce blood vessel spasms after an aneurysm rupture. The focus is on individuals who have experienced a subarachnoid hemorrhage, a specific type of brain bleed. Participants will receive either spinal cord stimulation or a placebo treatment for comparison. Ideal candidates are those diagnosed with severe aneurysmal subarachnoid hemorrhage and able to undergo certain standard medical procedures.

As an unphased trial, this study allows participants to contribute to groundbreaking research that could lead to new treatment options.

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 prior data suggests that spinal cord stimulation is safe for reducing cerebral vasospasm?

Research has shown that spinal cord stimulation (SCS) is generally safe for people. One study on using SCS to prevent blood vessel spasms in the brain found it safe and feasible, with most participants experiencing no major issues.

SCS is also used in other treatments, such as pain management, and has demonstrated good results with few serious side effects. Some individuals might experience minor side effects, like tingling or discomfort, but these usually resolve quickly.

Overall, research suggests that SCS is a safe option for many, including those with brain and spine conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for cerebral vasospasm, such as medications like nimodipine or endovascular procedures, spinal cord stimulation offers a new approach by directly applying electrical impulses to the spinal cord. This method could help regulate blood flow and reduce spasms by targeting the nervous system more precisely. Researchers are excited about this technique because it has the potential to offer faster relief with fewer side effects, providing a non-invasive alternative to current options.

What evidence suggests that spinal cord stimulation is effective for reducing cerebral vasospasm?

Research has shown that spinal cord stimulation (SCS), which participants in this trial may receive, can improve blood flow in the brain. One study found that SCS increases blood flow almost immediately, potentially preventing blood vessel spasms. Another study confirmed that SCS is safe and effective at reducing these spasms after an aneurysm bursts. Research also highlights several ways SCS benefits blood vessels, not only in the brain but throughout the body. These findings suggest that SCS could help manage sudden narrowing of a brain blood vessel, making it a potentially useful treatment option. ^{1 2 3 5 6}

Who Is on the Research Team?

Jesse Jones, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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

Does not provide consent for the procedure

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2291393/

Putative mechanisms behind effects of spinal cord stimulation ... This review summarizes the multiple mechanisms of SCS employed to create beneficial effects on the vascular system in the lower limbs, feet, heart and brain.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00766844

Cervical Spinal Cord Stimulation for the Prevention of ... The study investigates safety, feasibility and effectiveness of cervical spinal cord stimulation (SCS) in prevention of cerebral arterial vasospasm following ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2324242625000415

Research progress in spinal cord electrical stimulation for ... The present article reviews the current research status and development trends of SCS in promoting consciousness recovery in patients with DOC.

4. thejns.org thejns.org/view/journals/j-neurosurg/109/6/article-p1148.xml

Effect of electrical stimulation of the cervical spinal cord on ... Spinal cord stimulation caused an immediate increase in LDF within 10 seconds in both groups. Thereafter, LDF values progressively decreased, reaching values ~ ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6391880/

Spinal Cord Stimulation: Clinical Efficacy and Potential ... In the conventional SCS arm of the SENZA RCT, 55.5% of patients were found to have a successful outcome, a value similar to that seen in older studies (for ...

6. frontiersin.org frontiersin.org/journals/cellular-neuroscience/articles/10.3389/fncel.2023.1095259/full

Electrical stimulation for the treatment of spinal cord injuries Epidural electrical stimulation, peripheral nerve stimulation, and functional electrical stimulation have shown promising improvements for individuals with SCI, ...