What side effects are associated with this type of intervention?

The most common treatments for Spinal Cord Injury (SCI) involving electrical stimulation, such as sacral root stimulation to promote bladder emptying, can have side effects including a warm sensation, numbness in the arm or hand, redness, itching, tingling, muscle spasms, and localized pain in the arm, shoulder, or neck. These side effects are generally mild and transient. Additionally, there is a theoretical risk of triggering seizures in patients with epilepsy when using transcranial magnetic stimulation (TMS). Overall, while these treatments can be effective, they should be carefully considered and monitored by healthcare professionals.

What prior FDA approvals exist?

The FDA has approved several neuromodulation devices for the treatment of spinal cord injury (SCI), particularly for bladder management. One such device is the implanted sacral root stimulator, which helps in bladder emptying by stimulating the spinal nerves connected to the bladder. This method often involves cutting nerves to prevent unwanted reflexes. Additionally, the FDA has approved other neuromodulation techniques like transcutaneous electrical nerve stimulation (TENS) and transcranial magnetic stimulation (TMS) for various conditions, which may offer insights into similar treatments for SCI.

What other types of research exist?

Promising novel alternatives to Electrical Stimulation of Sacral Roots for SCI patients include: 1) Intravesical botulinum toxin A injections, which can reduce bladder pain and improve bladder function by relaxing the detrusor muscle. 2) Percutaneous tibial nerve stimulation, which has shown efficacy in treating overactive bladder symptoms. 3) Event-driven electrical stimulation of the dorsal penile/clitoral nerve, which can manage neurogenic detrusor overactivity. These alternatives offer less invasive options and have shown positive outcomes in clinical studies.

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Device

High Frequency SARS for Spinal Cord Injury (SARS600 Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for spinal cord injury (SCI) include various forms of electrical stimulation, such as sacral root stimulation, which is being studied for its ability to promote bladder emptying by relaxing the urethral sphincter. These treatments work by delivering electrical impulses to specific nerves, which can help modulate neural activity and improve function. For instance, sacral root stimulation targets the nerves connected to the bladder, helping to coordinate bladder and sphincter activity, thus reducing the need for catheters. This is crucial for SCI patients as it can significantly improve their quality of life by reducing the risk of infections and enhancing bladder control.

Phase < 1

Waitlist Available

Led By Dennis Bourbeau, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Suprasacral SCI

Neurologically stable

Must not have

Significant urethral trauma, erosion, or stricture

Bleeding diathesis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new electrical stimulation pattern to help people with spinal cord injuries empty their bladders. The treatment uses electrical signals to relax the muscle that controls urine release. It aims to help these individuals urinate without needing additional surgeries or catheters. Electrical stimulation has been used historically to treat bladder dysfunction by causing muscle contraction and modulating central nervous system functions.

Who is the study for?

This trial is for adults with spinal cord injury who already use a SARS System to manage bladder function. They should be neurologically stable and not have any major urethral damage, active infections, open sores near the pelvis, or bleeding disorders.

What is being tested?

The study tests if stimulating sacral roots at certain frequencies can help empty the bladder without cutting nerves. Participants with an implanted device will try new stimulation patterns aimed at relaxing the sphincter to improve bladder emptying.

What are the potential side effects?

Potential side effects may include discomfort from electrical stimulation and possible irritation at the site of implantation. There might also be risks related to changes in bladder or bowel function due to altered nerve stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spinal cord injury is above my lower back.

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My neurological condition is stable.

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My bones have stopped growing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had major injury or narrowing of my urethra.

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I have a bleeding disorder.

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I am currently suffering from a severe infection.

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I have open sores near my pelvis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

urethral sphincter pressure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

The investigators will test an alternative pattern of sacral root stimulation in individuals who are already implanted with the device. Study participants will act as their own controls.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Finetech-Brindley Sacral Anterior Roots Stimulation System

2022

Completed Early Phase 1

~10

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for spinal cord injury (SCI) include various forms of electrical stimulation, such as sacral root stimulation, which is being studied for its ability to promote bladder emptying by relaxing the urethral sphincter. These treatments work by delivering electrical impulses to specific nerves, which can help modulate neural activity and improve function. For instance, sacral root stimulation targets the nerves connected to the bladder, helping to coordinate bladder and sphincter activity, thus reducing the need for catheters. This is crucial for SCI patients as it can significantly improve their quality of life by reducing the risk of infections and enhancing bladder control.