Spinal Cord Stimulation for Phantom Limb Pain

Overseen By Casey Konopisos

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lee Fisher, PhD

Disqualifiers: Open wounds, Metal rods, Defibrillator, 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: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how electrical stimulation of the spinal cord can manage phantom limb pain, which occurs after losing a limb. Researchers will test a spinal cord stimulation system to determine the sensations it creates and its potential for pain control. Participants must already have a spinal cord stimulator device implanted for pain management and be able to communicate their sensations. This trial targets individuals with existing spinal cord stimulation devices who seek to improve their pain management. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to enhance their pain management strategies.

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 might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this spinal cord stimulation system is safe for use in individuals with implanted stimulation systems?

Research has shown that spinal cord stimulation effectively manages chronic pain, including phantom limb pain. This treatment, in use since 1967, has a long history. Studies have found that it can significantly reduce pain for some patients and sometimes even provide almost complete relief.

However, possible side effects include infections, fluid build-up, bleeding under the skin, or injuries to the nerves and spinal cord. While these issues are uncommon, they can occur.

Overall, spinal cord stimulation is considered a safe treatment, with many years of use supporting its safety. However, like any procedure, it carries some risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Spinal cord stimulation for phantom limb pain is unique because it uses an external stimulator connected to an implanted system to directly target the spinal cord, potentially offering more precise pain relief. Unlike standard treatments like medications or physical therapy, which can have systemic effects or limited success, this method focuses on the nerve pathways involved in pain perception. Researchers are excited because this targeted approach could result in more effective and immediate relief for patients, addressing a significant challenge in managing phantom limb pain.

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

Studies have shown that spinal cord stimulation, which participants in this trial will receive, can greatly reduce pain in people with phantom limb pain. Some patients even experience almost complete relief. Research indicates that this treatment provides long-term pain control in 14% to 80% of cases. It uses gentle electrical pulses near the spinal cord to manage pain that hasn't improved with other treatments. Overall, spinal cord stimulation offers a promising option for those dealing with chronic pain conditions like phantom limb pain. ^{1 2 3 6 7}

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 individuals aged 18-70 with Phantom Limb Syndrome or similar conditions, who are already part of a pain management clinical trial involving an epidural spinal cord stimulator. Participants must understand the consent process and procedures.

Inclusion Criteria

I am part of Dr. Helm's clinical trial for pain management using an epidural spinal cord electrode.

Persons must understand the consent and the procedures.

Exclusion Criteria

You have permanent metal tags or decorations on your skin.

You have metal rods in your spine or limbs.

You have a defibrillator or pacemaker.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Stimulation Trials

Participants undergo psychophysical stimulation trials with an external stimulator connected to the SCS lead to characterize sensory responses.

2 days

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after stimulation trials

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Spinal cord stimulation system

Trial Overview The study tests how different sensations can be created by electrically stimulating the spinal cord using implanted devices. It aims to control sensation type, intensity, and location through these devices while participants report their experiences.

How Is the Trial Designed?

Group I: Stimulation in individuals with implanted stimulation systems Experimental Treatment 1 Intervention

During psychophysical stimulation trials, an external stimulator will be connected to the SCS lead, a volley of stimulation will be performed, and the subject will be asked to respond to standard psychophysical questions, as well as to provide any additional comments.

Who Is Running the Clinical Trial?

Lee Fisher, PhD

Lead Sponsor

Trials

4

Recruited

70+

Published Research Related to This Trial

Spinal cord stimulation (SCS) is effective in improving pain relief, sleep quality, and functional activities in patients with chronic pain, as shown by a survey of 30 patients who reported positive outcomes after receiving different SCS devices.

While there were no significant differences in pain relief and sleep improvement among the three SCS device manufacturers (Medtronic, Advanced Bionics, and ANS), the Advanced Bionics group showed less functional improvement compared to the other two groups, suggesting that device technology may influence certain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of spinal cord stimulation, overall, and the effect of differing spinal cord stimulation technologies on pain, reduction in pain medication, sleep, and function. Haddadan, K., Krames, ES.[2022]

In a study of 8326 patients who underwent spinal cord stimulation (SCS) implantation, the overall incidence of spinal cord injury (SCI) was found to be low at 2.13%, indicating that SCS is a generally safe procedure.

There was no significant difference in the rates of SCI or spinal hematoma between patients receiving percutaneous (2.35%) and paddle (1.71%) electrode implantation, suggesting similar safety profiles for both methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. Petraglia, FW., Farber, SH., Gramer, R., et al.[2022]

In a study involving 49 patients with resistant deafferentation pain, spinal cord stimulation (SCS) was effective, with 57% of those who received permanent implants reporting over 75% pain relief after an average follow-up of 5.5 years.

The procedure had a low incidence of side effects, with only two cases requiring replacement of the stimulator due to electrode dislodgement and wire extrusion, indicating a relatively safe profile for this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation in deafferentation pain. Sánchez-Ledesma, MJ., García-March, G., Diaz-Cascajo, P., et al.[2018]

In a global study involving 1881 participants, spinal cord stimulation (SCS) demonstrated a high level of safety, with a low annualized device explant rate of 3.5% and only 1.1% due to inadequate pain relief.

The most common serious adverse event was implant site infection, occurring in less than 1% of cases, indicating that SCS is generally safe for chronic pain management over a follow-up period of up to 3 years.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. Rauck, RL., Loudermilk, E., Thomson, SJ., et al.[2023]

In a study of 402 patients with chronic pain who received spinal cord stimulation (SCS) devices, 55% of those with lower limb pain and 67% with upper limb pain reported a significant reduction in pain (≥50% reduction) after 2 years, indicating the long-term effectiveness of SCS.

The majority of patients (91%) were satisfied with their treatment, and 93% would choose to undergo the procedure again, while also showing a significant decrease in the need for pain medications, highlighting both the efficacy and safety of SCS therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. Brinzeu, A., Cuny, E., Fontaine, D., et al.[2019]

In a study of four patients with intractable phantom limb pain, spinal cord stimulation (SCS) resulted in over 80% pain relief for three patients, demonstrating its potential efficacy as a treatment option.

While SCS was generally well-received, with most patients expressing satisfaction, there were complications such as allergic reactions and infections, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of spinal cord stimulation in the treatment of phantom limb pain: case series and review of the literature. Viswanathan, A., Phan, PC., Burton, AW.[2022]

A patient with debilitating bilateral phantom limb pain experienced complete pain relief after upgrading from a constant voltage spinal cord stimulator (SCS) to a constant current system, along with the addition of percutaneous leads.

This case suggests that modifying existing SCS systems by changing the generator type and adding leads can effectively address evolving pain patterns in patients with phantom limb pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complete coverage of phantom limb and stump pain with constant current SCS system: a case report and review of the literature. Bunch, JR., Goldstein, HV., Hurley, RW.[2018]

A study of patients with chronic neuropathic pain who experienced loss of efficacy from spinal cord stimulation (SCS) showed significant improvements in pain intensity and quality of life after using new stimulation waveforms through implanted pulse generator adapters.

After 12 months, 81.3% of patients preferred the tonic stimulation option, indicating that these adapters could be an effective salvage solution for managing patients with decreased SCS effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Challenge of Converting "Failed Spinal Cord Stimulation Syndrome" Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment: A Real Life Retrospective Study. Rigoard, P., Ounajim, A., Goudman, L., et al.[2022]

Dorsal column stimulation (DCS) provided good to excellent relief of phantom pain in 5 out of 6 patients over follow-up periods ranging from 7 to 25 months.

One patient experienced a failure in pain relief due to intolerance of the DCS apparatus, highlighting the importance of patient comfort in the treatment's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phantom limb pain. Treatment with dorsal column stimulation. Nielson, KD., Adams, JE., Hosobuchi, Y.[2007]

Spinal cord stimulation (SCS) is an effective surgical treatment for chronic neuropathic pain, with success rates ranging from 50-75% when performed by experienced practitioners, and is indicated for conditions like complex regional pain syndrome and diabetic neuropathy.

The procedure involves implanting leads in the spinal canal to deliver electrical currents, but it carries risks such as lead migration and infection, and its exact mechanisms of action remain only partially understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation: Background and clinical application. Meier, K.[2022]

A clinical trial is being conducted to compare the effectiveness of new spinal cord stimulation (SCS) patterns, specifically differential target multiplexed (DTM) and fast-acting subperception therapy (FAST), against conventional tonic stimulation for chronic neuropathic pain, involving multiple participants over a structured testing period.

The study will assess pain improvement using a visual analog scale (VAS) and aims to determine which stimulation pattern is most effective for different types of neuropathic pain, while also monitoring for any adverse events related to the new therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the latest new stimulation patterns of spinal cord stimulation for intractable neuropathic pain compared to conventional stimulation: study protocol for a clinical trial. Tanei, T., Maesawa, S., Nishimura, Y., 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]

Spinal cord stimulation (SCS) using the Medtronic Prime Advance system provided significant pain relief for a 61-year-old man with phantom limb pain, reducing his pain score from 8/10 to 2/10 after treatment.

Despite initial success, the patient experienced a resurgence of pain (4/10) six months later, indicating that while SCS can be effective, long-term management of phantom limb pain may still require ongoing treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation in The Treatment of Phantom Limb Pain: A Case Report and Review of Literature. Raut, R., Shams, S., Rasheed, M., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11932836/

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

2. 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, ...

3. journals.lww.com journals.lww.com/neur/fulltext/2021/69010/spinal_cord_stimulation_in_the_treatment_of.30.aspx

Spinal Cord Stimulation in The Treatment of Phantom Limb... The success rate of SCS in long term pain control in PLP ranges from 14-80%. The effectiveness of Dorsal Root Entry Zone lesioning on a phantom limb with intact ...

4. 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 ...

5. academic.oup.com academic.oup.com/painmedicine/article/15/2/188/1824069

State of the Field Survey: Spinal Cord Stimulator Use by ... The ultimate objective of spinal cord stimulation is to decrease pain that has failed more conservative therapy in order to improve patient function and quality ...

6. emedicine.medscape.com emedicine.medscape.com/article/1980819-overview

Spinal Cord Stimulation: Background, Indications, ... Other disorders, such as postherpetic neuralgia, axial low back pain, and phantom limb pain present an unknown probability of pain reduction.

7. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/123443-biologic-complications-associated-with-cylindrical-lead-spinal-cord-stimulator-implants-a-narrative-review

Biologic Complications Associated with Cylindrical Lead ... Biologic complications include infection, seromas, hematomas, dural puncture, nerve or spinal cord injury, and therapy habituation.