What side effects are associated with this type of intervention?

Spinal Cord Stimulation (SCS) for Spinal Cord Injury (SCI) can have several side effects. Common ones include mild to moderate discomfort at the implantation site, infection, bleeding, and hardware-related issues such as lead migration or breakage. Patients may also experience paresthesia, an abnormal sensation like tingling or prickling. Serious adverse events are rare but can include neurological damage or worsening of pain. These side effects are generally manageable and should be discussed with a healthcare provider to weigh the benefits and risks.

What prior FDA approvals exist?

Spinal Cord Stimulation (SCS), also known as Epidural Electrical Stimulation (EES), is a treatment approach for managing pain and improving motor and sensory functions in patients with Spinal Cord Injury (SCI). The FDA has approved various SCS devices for chronic pain management, which can be adapted for SCI treatment. These devices deliver electrical impulses to the spinal cord to modulate pain signals and potentially enhance motor and sensory functions. While specific FDA approvals for SCI-focused SCS are not detailed, the general approval of SCS devices for pain management provides a foundation for their use in SCI treatment. Additionally, conventional medical management (CMM) often includes medications such as analgesics and muscle relaxants to complement the effects of SCS.

What other types of research exist?

Promising novel alternatives to Spinal Cord Stimulation for Spinal Cord Injury patients include: 1) Transcutaneous Electrical Nerve Stimulation (TENS), which provides symptomatic relief by modifying pain perception through surface electrodes. 2) Percutaneous Electrical Nerve Stimulation (PENS), which involves inserting needles into soft tissue and applying electrical stimulation to target dermatomal levels. 3) Remote Electrical Neuromodulation (REN), which uses a device controlled by a smartphone to apply nonpainful electrical skin stimulation, reducing acute pain. 4) Transcranial Magnetic Stimulation (TMS), which has shown potential in reducing headache days and functional disability in migraine patients and may be explored for SCI pain management.

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Procedure

SCS for Spinal Cord Injury

N/A

Recruiting

Led By Shivanand Lad, MD, PhD

Research Sponsored by Nandan Lad, M.D., Ph.D.

Eligibility Criteria Checklist

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

Must have

Subjects must have chronic pain (i.e., Pain >3 for > 3 months)

Subjects must be 18-80 years of age

Must not have

Subjects must not have untreated, clinically significant depression

Subjects must not have persistent spinal instability or other injury preventing ability to participate

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 months

Summary

This trial is testing Spinal Cord Stimulation (SCS) for patients with Spinal Cord Injury (SCI) to manage pain and improve physical functions. The treatment uses electrical pulses to interfere with pain signals and may help with movement and sensation. Patients will receive either active SCS treatment or their usual care. Spinal cord stimulation (SCS) has been used since 1967 and is an evidence-based treatment for various chronic pain disorders, including failed back surgery syndrome (FBSS).

Who is the study for?

This trial is for adults aged 18-80 with traumatic thoracic spinal cord injury and chronic pain, who can consent to the study and attend required visits. Candidates must be medically stable for SCS implant surgery and rehabilitation but cannot have complete cord transection, untreated major depression, active infection or substance abuse, or be pregnant.

What is being tested?

The study compares Spinal Cord Stimulation (SCS) plus conventional medical management (CMM) against CMM alone in managing SCI pain and aiding rehabilitation. Participants will either receive SCS turned on or off randomly while continuing CMM like medications and physical therapy for a year.

What are the potential side effects?

Potential side effects of SCS may include discomfort at the implant site, unwanted changes in bladder/bowel function or sensation, bleeding, infection risk from surgery, possible equipment failure, and varying responses to pain relief.

Eligibility Criteria

Inclusion Criteria

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

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I have been in pain for more than 3 months.

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I am between 18 and 80 years old.

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I am medically fit for surgery and rehabilitation.

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I have a spinal cord injury in my chest area due to trauma.

Exclusion Criteria

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

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I do not have untreated, significant depression.

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I do not have a spinal condition that stops me from taking part in activities.

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I do not have any current infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 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

Pain

Motor recovery as measured by EMG

Motor recovery as measured by dynamometry

Secondary study objectives

Change in Quality of Life (QOL) as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) 29

Urinary Bladder

Spinal Cord

+7 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: EES onExperimental Treatment1 Intervention

Patients will undergo epidural electrical stimulation (EES) and be randomized in a 1:1 allocation to EES on. Both the patient and the provider will be formally blinded to treatment assignment. Only the biostatistician and programming team will be unblinded to treatment assignments.

Group II: EES offPlacebo Group1 Intervention

Patients will undergo epidural electrical stimulation (EES) and be randomized in a 1:1 allocation to EES off. Both the patient and the provider will be formally blinded to treatment assignment. Only the biostatistician and programming team will be unblinded to treatment assignments.ES off. Those in the EES off category will have their EES turned on at the 9-month timepoint.

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

Spinal Cord Stimulation (SCS) works by delivering electrical impulses to the spinal cord, which modulate nerve activity to manage pain and improve motor and sensory functions. This treatment alters pain signals before they reach the brain and enhances neural plasticity, potentially leading to functional improvements. For Spinal Cord Injury (SCI) patients, SCS offers a non-pharmacologic option that can reduce pain and improve quality of life, especially when conventional treatments are insufficient.

Principles of electrical stimulation and dorsal column mapping as it relates to spinal cord stimulation: an overview.