Epidural Stimulation for Spinal Cord Injury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Kessler Foundation

Disqualifiers: Heart, lung, bladder, kidney, others

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the long-term effects of spinal cord stimulation for individuals with spinal cord injuries. The researchers aim to determine if the stimulation can continue to improve quality of life and collect safety data over time. Participants will use stimulation programs at home and visit the research site for follow-ups. It is ideal for those with a stable spinal cord injury who have previously participated in an epidural stimulation study and wish to continue using the stimulator.

As an unphased trial, it offers participants the chance to contribute to valuable research that could enhance future 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's best to discuss this with the research team to get a clear answer.

What prior data suggests that epidural stimulation is safe for individuals with spinal cord injury?

Research has shown that epidural spinal cord stimulation (eSCS) is generally safe for people with spinal cord injuries. Studies have found that its safety in helping restore movement and other functions is comparable to its use in treating chronic pain. This indicates that the risks are similar to those already known for chronic pain treatments, which are well-documented.

In one study, some participants stood better without assistance, suggesting the treatment could enhance movement. While complications can occur, they are similar to those in other procedures involving nerve stimulation, such as post-surgical issues.

Overall, evidence suggests that eSCS is well-tolerated. If it had been unsafe in early trials, it would not have progressed to studies like this one. However, as with any medical procedure, risks exist. Consult a healthcare professional about any concerns to determine if this treatment is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Epidural Stimulation is unique because it offers a new way to help people with spinal cord injuries regain movement and sensation. Unlike traditional rehabilitation therapies that often focus on physical exercises and assistive devices, this treatment involves placing a small device near the spinal cord to send electrical signals that can help activate nerve circuits. Researchers are excited about this approach because it has the potential to improve mobility and quality of life by directly targeting the spinal cord in a way that other treatments cannot. This could mean new possibilities for recovery and independence for people with spinal cord injuries.

What evidence suggests that epidural stimulation is effective for spinal cord injury?

Research has shown that epidural stimulation, the treatment under study in this trial, can help people with spinal cord injuries regain some movement and function. One study found that this treatment helped individuals with long-term spinal cord injuries move again. Another study demonstrated that many participants experienced meaningful improvements in their conditions. These findings suggest that epidural stimulation could be a promising way to enhance the quality of life for people with spinal cord injuries. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with spinal cord injury or tethered cord syndrome who have previously used epidural stimulators and found them beneficial. They must be able to use the stimulation programs independently at home and commit to follow-up visits at Kessler Foundation every 6 months, then annually.

Inclusion Criteria

Received a neurostimulator and electrode array as part of a previous study

My spinal cord injury is stable.

Have completed a previous IRB approved epidural stimulation study at a participating research site

Exclusion Criteria

Unable to undergo an MRI

I do not have untreated heart, lung, bladder, kidney, or other medical conditions unrelated to spinal cord injury.

I choose not to use epidural stimulation as recommended.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Home Use and Follow-Up

Participants use stimulation programs at home and attend follow-up visits for assessments

Long-term

Visits at 6 months, 1 year, and yearly

Follow-up

Participants are monitored for safety and effectiveness after treatment

Long-term

In-person or remote visits

What Are the Treatments Tested in This Trial?

Interventions

• Epidural Stimulation

Trial Overview The study focuses on long-term effects of using epidural stimulation programs in people with spinal injuries. It aims to support participants, minimize their travel costs, gather safety data over time, and assess the sustainability of health outcomes from continued use.

How Is the Trial Designed?

Group I: Home Use and Follow-Up Visit Group Experimental Treatment 1 Intervention

Participants will be cleared by study staff for home-use of the stimulation programs they received in the previous study. Participants will then follow and log the programs according to study staff recommendations.

Who Is Running the Clinical Trial?

Kessler Foundation

Lead Sponsor

Trials

190

Recruited

11,300+

Citations

1. nature.com nature.com/articles/s41591-024-02940-9

Non-invasive spinal cord electrical stimulation for arm and ... Of the 60 participants included in the primary effectiveness endpoint analysis, 43 (72%) met or exceeded the minimally important difference (MID) ...

2. spj.science.org spj.science.org/doi/10.34133/cbsystems.0314

Epidural Electrical Stimulation for Functional Recovery in ... This study confirms the promising therapeutic effects of EES in SCI. EES combined with PT provides a potential approach for functional recovery in patients ...

3. e-neurospine.org e-neurospine.org/journal/view.php?doi=10.14245/ns.2244652.326

A Review of Functional Restoration From Spinal Cord ... This review aims to assess the efficacy of spinal cord stimulation, both epidural (eSCS) and transcutaneous (tSCS), on the return of function in individuals ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07105878

Epidural Electrical Stimulation in Spinal Cord Injury The goal of this clinical trial is to evaluate the safety and effectiveness of Epidural Electrical Stimulation (EES) in motor and sensory function ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9297213/

Effect of epidural spinal cord stimulation after chronic spinal ... The aim of this study is to assess the effects of tonic eSCS after chronic SCI on quantitative outcomes of volitional movement and cardiovascular function.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35701485/

The safety of epidural spinal cord stimulation to restore ... Conclusions: eSCS to restore autonomic and volitional motor function following SCI has a similar safety profile as when used to treat chronic pain, despite the ...

7. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT07042815

Long-term Follow-up for Epidural Stimulation in SCI The goal of this study is to understand long-term effects of spinal cord stimulation in individuals who have a spinal cord injury. The main aims are to: provide ...

8. nature.com nature.com/articles/s41467-023-37845-7

A case study of percutaneous epidural stimulation to ... The safety of epidural spinal cord stimulation to restore function after spinal cord injury: post-surgical complications and incidence of ...

9. tandfonline.com tandfonline.com/doi/full/10.1080/10790268.2025.2517935?src=

Spinal epidural electrical stimulation for the recovery of ... With epidural stimulation, four subjects gained better control of standing full weight bearing (without assistance). Four (80%) subjects were ...