What side effects are associated with this type of intervention?

Common treatments for Spinal Cord Injury (SCI) that are similar to Lumbosacral Spinal Cord Epidural Stimulation (scES) include various forms of electrical stimulation and neuromodulation. Known side effects of these treatments can include mild device-associated adverse events such as a warm sensation, numbness, redness, itching, tingling, muscle spasms, and localized pain in areas such as the arm, shoulder, or neck. More serious adverse events are rare but can include the risk of triggering seizures in patients with epilepsy when using transcranial magnetic stimulation (TMS). Overall, these treatments are generally considered safe with a low incidence of severe complications.

What prior FDA approvals exist?

The FDA has approved various treatments for spinal cord injury, focusing on both pharmacologic and non-pharmacologic approaches. While specific FDA approvals for lumbosacral spinal cord epidural stimulation (scES) are not detailed, similar neuromodulation techniques like transcutaneous electrical nerve stimulation (TENS) and percutaneous electrical nerve stimulation (PENS) have been explored for pain management and functional improvement in SCI patients. These treatments aim to modulate neural circuits to alleviate symptoms and improve quality of life. Additionally, pharmacologic treatments such as corticosteroids have been used to reduce inflammation and secondary damage post-injury.

What other types of research exist?

Promising novel alternatives to Lumbosacral Spinal Cord Epidural Stimulation (scES) for spinal cord injury patients include: 1) Transcutaneous Electrical Nerve Stimulation (TENS) and Percutaneous Electrical Nerve Stimulation (PENS), which have shown efficacy in pain relief and motor function improvement. 2) Phrenic Nerve Stimulation, which can aid in respiratory function for patients with diaphragm paralysis. 3) Sacral Nerve Stimulation, which is being explored for bladder and bowel dysfunction. 4) Advanced implantable devices for gastric electrical stimulation, which may offer benefits for autonomic function. These alternatives are under investigation and may provide additional options for SCI patients in 2024.

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Procedure

Epidural Stimulation for Spinal Cord Injury (TSEPI Trial)

N/A

Recruiting

Led By Susan J Harkema, PhD

Research Sponsored by University of Louisville

Eligibility Criteria Checklist

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

Must have

At least 18 years of age

Non-progressive spinal cord injury

Must not have

Cardiovascular, respiratory, bladder, or renal disease unrelated to spinal cord injury

Untreated painful musculoskeletal dysfunction, fracture or pressure sore

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial uses electrical stimulation of the lower spinal cord to help people with severe spinal cord injuries who can't move their legs or stand. The electrical signals aim to reactivate nerves, improving movement and other bodily functions. Electrical stimulation of the spinal cord has been used for pain relief, spasticity control, and movement restoration in spinal cord injury patients.

Who is the study for?

This trial is for adults over 18 with severe spinal cord injury, unable to stand or move legs voluntarily, and experiencing issues like low blood pressure and respiratory dysfunction. They should be at least two years post-injury with stable health but can't join if they use nicotine, have certain implants, untreated conditions, or are pregnant.

What is being tested?

The study tests how epidural stimulation (scES) helps recover functions affected by spinal cord injuries. Participants will receive scES aimed at improving cardiovascular function, voluntary movement of legs/trunk, or standing ability. The impact on quality of life and healthcare costs will also be evaluated.

What are the potential side effects?

While the description doesn't specify side effects directly related to the interventions being studied (epidural stimulation and stand training), such procedures may cause discomfort at the stimulation site, muscle spasms or changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My spinal cord injury is not getting worse.

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It has been over 2 years since my injury.

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I have trouble controlling my bladder or emptying it completely.

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My lung function is at least 15% below what is expected for someone my age and size.

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I cannot move all the joints in my legs on my own.

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I cannot stand up on my own.

Exclusion Criteria

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

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I have heart, lung, bladder, or kidney conditions not caused by a spinal cord injury.

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I have untreated painful bone or muscle issues, fractures, or pressure sores.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

5Treatment groups

Experimental Treatment

Group I: Voluntary Movement ES + Stand TrainingExperimental Treatment1 Intervention

Participants assigned to this group will receive epidural stimulation specific for voluntary movement and will also receive stand training.

Group II: Epidural Stimulation for Voluntary MovementExperimental Treatment1 Intervention

Participants assigned to this group receive epidural stimulation specifically for voluntary movement.

Group III: Epidural Stimulation for Cardiovascular stability during daily activitiesExperimental Treatment1 Intervention

Participants assigned to this arm will receive be randomized to receive epidural stimulation specific for cardiovascular function alone or cardiovascular function and standing, or voluntary movement alone or voluntary movement and standing.

Group IV: Cardiovascular ES + Stand TrainingExperimental Treatment1 Intervention

Participants assigned to this group will receive epidural stimulation specific for cardiovascular function and will also receive stand training.

Group V: Acute Epidural Stimulation for Cardiovascular Stability.Experimental Treatment1 Intervention

Participants are assessed both with and without epidural stimulation for cardiovascular stability for persistent hypotension, orthostatic hypotension and autonomic dysreflexia.

0 / 9Eligibility 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

Spinal cord epidural stimulation (scES) works by delivering electrical impulses to the spinal cord to modulate neural circuits, aiming to restore autonomic and motor functions disrupted by spinal cord injury (SCI). This treatment is significant for SCI patients as it can potentially improve voluntary movement, standing ability, and autonomic functions such as cardiovascular and respiratory control. By re-establishing communication pathways within the spinal cord, scES offers a promising approach to enhance the quality of life and functional independence for individuals with severe SCI.