Spinal Cord Stimulation for Lower Extremity Amputation

(SCS-90 Trial)

Overseen By Sydney Bader

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lee Fisher, PhD

Must not be taking: Blood thinners, Immunosuppressants

Disqualifiers: Pregnancy, Renal failure, Cardiac devices, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist individuals who have lost a lower leg between the ankle and knee and experience phantom limb pain. It investigates the use of a spinal cord stimulator, a device that sends electrical signals to nerves, to create sensations that might reduce pain. Researchers will examine how these signals affect both the sensation in the phantom limb and the use of a prosthetic limb. Ideal participants are those who have used their current prosthetic leg for at least six months and continue to experience phantom limb sensations and pain. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance pain management for many.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that affect blood coagulation or are receiving immunosuppressive medications.

What prior data suggests that this spinal cord stimulation is safe for lower limb amputees?

Research has shown that spinal cord stimulation has been safely used to manage various types of chronic pain since 1967. It sends electrical pulses near the spinal cord to help reduce pain. Many patients have tolerated this method well and found relief from their symptoms.

One study involving people with chronic back and leg pain found spinal cord stimulation to be safe and effective over the long term. Patients reported improvements with few side effects. Some might feel mild tingling or discomfort where the stimulation occurs, but serious issues are rare.

Overall, spinal cord stimulation has a long history of use and is generally considered safe for managing pain, including phantom limb pain after amputations. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for phantom limb pain, which often includes medications like opioids and antidepressants, spinal cord stimulation (SCS) offers a different approach by directly targeting the nervous system. Researchers are excited about SCS because it involves placing stimulator leads in the lumbar epidural space to potentially reduce pain by modulating nerve signals before they reach the brain. This method could provide pain relief without the side effects associated with long-term medication use, offering a more precise and potentially safer alternative for amputees experiencing phantom limb sensations.

What evidence suggests that spinal cord stimulation is effective for reducing phantom limb pain?

Research has shown that spinal cord stimulation, which participants in this trial will receive, can help reduce phantom limb pain—the pain felt in an amputated limb. Studies have found that some patients experience significant pain relief, with a few achieving almost complete relief. Even for those who have endured phantom limb pain for many years, spinal cord stimulation has proven effective. This method presents a promising and less invasive alternative to pain medications like opioids. Overall, spinal cord stimulation offers hope for those facing the challenges of phantom limb pain. ^{2 3 6 7 8}

Who Is on the Research Team?

Lee Fisher, PhD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for lower-limb amputees aged 22-70 who are at least six months post-amputation, have been using their current prosthesis for over six months, and can walk with or without support. Pregnant women, those on blood thinners, with severe diseases, allergies to MRI contrast agents or renal failure, high hemoglobin A1c levels (>8.0 mg/dl), implanted devices not cleared for MRI (like pacemakers), immunosuppressed individuals or those in radiation-heavy professions cannot join.

Inclusion Criteria

I am between 22 and 70 years old.

I've used my current prosthesis for 6+ months and can walk with it.

It has been over 6 months since my amputation.

Exclusion Criteria

You have a high score on a questionnaire about your mental health and have been told by the study doctor and psychologist that you are not suitable for the study.

Your hemoglobin A1c level cannot be higher than 8.0 mg/dl when you get the implant.

I am not taking any blood-thinning medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Spinal cord stimulator leads are placed in the lumbar epidural space for up to 90 days to evaluate sensory feedback and pain reduction

12 weeks

Multiple visits for psychophysical and functional evaluations

Follow-up

Participants are monitored for safety and effectiveness after device removal

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spinal cord stimulator

Trial Overview The study tests a spinal cord stimulator designed to provide sensory feedback and reduce phantom limb pain in lower-limb amputees. It aims to understand how electrical stimulation of the spinal nerves affects sensation quality and prosthetic control while also measuring its impact on phantom limb perception and associated pain.

How Is the Trial Designed?

Group I: Spinal cord stimulation Experimental Treatment 1 Intervention

Spinal cord stimulator leads (2-3 leads) will be placed in the lumbar epidural space of lower limb amputees to determine if the patient experiences any pain reduction from spinal cord stimulation. Participants in this study receive spinal cord stimulation will be trans-tibial amputees that are at least six month post--amputation. Subjects will have varying levels of phantom limb sensation and pain, but should have no other significant neurological disorders.

Spinal cord stimulator is already approved in United States, European Union for the following indications:

Approved in United States as Spinal Cord Stimulation for:

• Chronic pain
• Phantom limb pain
• Neuropathic pain

Approved in European Union as Spinal Cord Stimulation for:

• Chronic pain
• Phantom limb pain
• Neuropathic pain

Who Is Running the Clinical Trial?

Lee Fisher, PhD

Lead Sponsor

Trials

4

Recruited

70+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

Electrical spinal cord stimulation (ESCS) provides significant and sustained pain relief for patients with chronic painful diabetic neuropathy, with median pain scores showing a marked reduction when the stimulator is on compared to when it is off.

The procedure has a low complication rate, with only two late complications reported among the patients, indicating that ESCS is a safe long-term treatment option for managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electrical spinal cord stimulation in the long-term treatment of chronic painful diabetic neuropathy. Daousi, C., Benbow, SJ., MacFarlane, IA.[2019]

In a study of 39 patients with nonreconstructable lower extremity ischemic vascular disease, spinal cord stimulation was successful in 77% of cases, significantly improving pain control and blood flow metrics like TcPO2 and peak blood flow velocity.

Patients with a pre-implantation TcPO2 of less than 30 mm Hg showed significant improvements post-stimulation, indicating that spinal cord stimulation can enhance perfusion and may be a valuable treatment option for severe cases without trophic changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of limb circulation in peripheral vascular disease using epidural spinal cord stimulation: a prospective study. Kumar, K., Toth, C., Nath, RK., et al.[2013]

Spinal cord stimulation (SCS) has shown long-term effectiveness in providing pain relief for some patients with amputation-related pain, with a mean self-reported pain relief of 66% over a follow-up period of up to 19 years.

While some patients experienced technical issues or waning benefits, the overall results suggest that SCS remains a viable treatment option, warranting further refinement of techniques to enhance its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for intractable pain following limb amputation. McAuley, J., van Gröningen, R., Green, C.[2022]

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]

Noninvasive transcutaneous spinal cord stimulation (tSCS) has been shown to effectively induce muscle activation in individuals with spinal cord injury, based on a systematic review of 13 studies involving 55 participants.

While tSCS appears to enhance voluntary movement, muscle strength, and function, further research is needed to determine the optimal electrode placement and current intensity for maximum efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Spinal Cord Stimulation and Motor Rehabilitation in Spinal Cord Injury: A Systematic Review. Megía García, A., Serrano-Muñoz, D., Taylor, J., et al.[2021]

In a study of 72 patients with critical limb ischemia (CLI) who received spinal cord stimulation (SCS), 59.2% were alive without major amputation after an average follow-up of 17.1 months, indicating that SCS can lead to significant limb salvage rates.

Patients classified as Fontaine's Stage III showed particularly favorable outcomes, with a 94% survival rate without major amputation, suggesting that SCS may be especially effective for those with less severe ischemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation in non-reconstructable critical limb ischemia: a retrospective study of 71 cases. Piedade, GS., Vesper, J., Reichstein, D., et al.[2023]

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. sciencedirect.com sciencedirect.com/science/article/pii/S2772594425000329

A scoping review of spinal cord stimulation for phantom ... Spinal cord stimulation appears to provide meaningful pain reduction for patients with phantom limb pain, with a subset achieving near-complete relief.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12529431/

Spinal Cord Stimulation Therapy for Phantom Limb Pain in the ... In this case, effective treatment was achieved using SCS for phantom limb pain that had persisted for 30 years. Although there were concerns ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05807607

Study of Lower-limb Phantom Pain Syndrome Using ... The purpose of this study is to evaluate the effectiveness of neuromodulation for relief of phantom limb pain (PLP) using peripheral nerve (PNS) and spinal cord ...

4. medrxiv.org medrxiv.org/content/10.1101/2023.04.13.23288483v1.full-text

Transcutaneous Spinal Cord Stimulation to Reduce ... Here we propose using a non-invasive neuromodulation method, transcutaneous spinal cord stimulation (tSCS), to reduce PLP in people with transtibial amputation.

5. lneuro.org lneuro.org/article/68766898a9539512da413ed5

Spinal cord stimulation in neuropathic pain following lower ... Conclusion: This study highlights spinal cord stimulation (SCS) as an effective, minimally invasive alternative to opioid therapy for phantom limb pain (PLP).

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK553154/

Spinal Cord Stimulation - StatPearls - NCBI Bookshelf - NIH This technique uses pulsed electrical energy near the spinal cord to manage pain. This activity reviews the indications, contraindications, equipment, ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923005755

Review article Spinal Cord Stimulation: An Update Spinal cord stimulation has been used in the treatment of many chronic pain disorders since 1967. In this update, the indications for spinal cord ...

8. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-025-01720-x

Characterizing spinal reflexes evoked by sensory ... People with lower-limb amputation lack sensory inputs from their missing limb, which increases their risk of falling.