Spinal Cord Stimulation for Phantom Limb Pain

(PhantomLimb Trial)

Overseen By Sydney Bader

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lee Fisher, PhD

Must not be taking: Blood thinners

Disqualifiers: Pregnancy, Serious diseases, 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: 25

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how electrical stimulation of nerves near the spinal cord affects sensations and pain in individuals with phantom limb pain following an upper-limb amputation. The procedure temporarily places electrodes near the spinal cord to trigger and study these sensations using the Boston Scientific Stimulator Lead, a type of neuromodulation device. This trial suits those who have had an upper-limb amputation for more than a year and are willing to travel to the University of Pittsburgh for several sessions over a month. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could lead to new pain management strategies.

Do I need to stop taking my current medications for the trial?

You must stop taking any medications that thin your blood to participate in the trial.

What prior data suggests that this spinal cord stimulation technique is safe for treating phantom limb pain?

Research has shown that spinal cord stimulation (SCS) is generally safe and well-tolerated. The Boston Scientific Stimulator Lead, used in this study, has FDA approval for treating chronic pain in the trunk and limbs, indicating it meets safety standards for these uses.

Strong clinical evidence supports the safety of SCS. Several top-quality trials have demonstrated its effectiveness and safety, reporting few negative side effects. Most participants experience little to no problems.

In summary, while any medical procedure carries risks, the Boston Scientific Stimulator Lead used in spinal cord stimulation has a strong safety record in similar treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for phantom limb pain focus on medications like opioids or antidepressants, which work by altering pain perception or mood. However, the Boston Scientific Stimulator Lead takes a different approach by using spinal cord stimulation. This treatment involves placing a device in the cervical epidural space to directly target nerve pathways associated with pain. Researchers are excited about this method because it offers a new way to potentially reduce pain by modulating neural signals, possibly providing relief without the side effects linked to traditional medications.

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

Research has shown that spinal cord stimulation (SCS) can greatly reduce phantom limb pain for many people. One review found that SCS helped some patients experience almost complete pain relief. Studies have also supported the effectiveness of SCS in managing long-term pain in the body and limbs. This trial will specifically evaluate the Boston Scientific Stimulator Lead for its effectiveness in reducing phantom limb pain. Overall, SCS has a strong record of providing excellent pain relief, making it a promising option for those dealing with phantom limb pain. ^{1 2 4 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 adults aged 18-70 who have had an upper-limb amputation at least a year ago and can visit the University of Pittsburgh twice weekly for about a month. Pregnant women, those planning to become pregnant, individuals with serious health conditions, or those on blood thinners cannot participate.

Inclusion Criteria

I have an amputation above the wrist.

It has been over a year since my amputation.

Be willing to travel to the University of Pittsburgh at least twice per week for 29 days

Exclusion Criteria

I am not taking blood thinners.

I do not have any serious illnesses that would prevent me from joining this study.

I am not pregnant and do not plan to become pregnant during the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Electrode Placement

Electrodes are temporarily placed near the spinal cord under local anesthesia

1 day

1 visit (in-person)

Experimental Sessions

Participants undergo up to 20 experimental sessions to test sensations and effects of spinal cord stimulation

30 days

Up to 20 visits (in-person)

Electrode Removal

Stimulation electrodes are removed at the end of the final experimental session

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in phantom limb sensation and pain after electrode removal

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Boston Scientific Stimulator Lead

Trial Overview The study tests if electrical stimulation via electrodes placed near the spinal cord in the upper back and neck can produce sensations from the amputated limb and reduce phantom limb pain. The procedure involves multiple testing sessions over less than 30 days with temporary electrode placement.

How Is the Trial Designed?

Group I: Boston Scientific cord stimulator lead Experimental Treatment 1 Intervention

A Boston Scientific Stimulator Lead (PMA P030017) will be placed in the cervical epidural space of ten upper-limb amputees and steered laterally towards the dorsal spinal roots under fluoroscopic guidance.

Boston Scientific Stimulator Lead is already approved in United States, European Union for the following indications:

Approved in United States as Boston Scientific Stimulator Lead for:

• Failed Back Surgery Syndrome (FBSS)
• Chronic Pain
• Complex Regional Pain Syndrome
• Intractable Angina
• Visceral Abdominal and Perineal Pain
• Pain in the Extremities from Nerve Damage

Approved in European Union as Boston Scientific Stimulator Lead for:

• Peripheral Ischemic Pain
• Failed Back Surgery Syndrome (FBSS)
• Chronic Pain
• Complex Regional Pain Syndrome

Who Is Running the Clinical Trial?

Lee Fisher, PhD

Lead Sponsor

Trials

4

Recruited

70+

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

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 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]

A prospective study involving 45 patients with failed back surgery syndrome (FBSS) demonstrated that a hybrid spinal cord stimulation (SCS) lead effectively alleviated both low back and leg pain, with significant reductions in pain scores after six months.

The average visual analog scale (VAS) scores dropped from 8.0 for leg pain and 7.5 for low back pain at baseline to 3.2 and 3.5, respectively, indicating substantial pain relief and a decrease in pain medication usage, confirming the safety and efficacy of this intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal cord stimulation with hybrid lead relieves pain in low back and legs. de Vos, CC., Dijkstra, C., Lenders, MW., et al.[2022]

In a study of five patients with chronic neuropathic pain, direct spinal-cord stimulation (SCS) paddle lead placement during the trial period resulted in significant and sustained pain relief, with preoperative visual analogue scale (VAS) scores improving from 9.4 to 1.4 after a mean follow-up of 23.6 months.

This technique not only avoided complications associated with lead migration and positional variations but also effectively addressed issues related to epidural scarring, suggesting it could be a reliable and cost-effective method for SCS lead placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paddle-Lead Spinal-Cord Stimulation Surgeries for Chronic Neuropathic Pain: A Single Surgeon Case-Series Outcome Analysis in Indian Population. Baruah, S., Banerjee, AD.[2023]

The ESTIMET trial is a multicenter, randomized study comparing the efficacy of monocolumn versus multicolumn spinal cord stimulation (SCS) in patients with failed back surgery syndrome (FBSS) and significant back pain, involving 115 patients across 14 centers in France.

The primary goal is to assess whether multicolumn SCS can achieve a greater than 50% reduction in low back pain severity at 6 months, addressing a common limitation of traditional SCS in managing back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multicolumn spinal cord stimulation for significant low back pain in failed back surgery syndrome: design of a national, multicentre, randomized, controlled health economics trial (ESTIMET Study). Roulaud, M., Durand-Zaleski, I., Ingrand, P., et al.[2016]

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]

Spinal cord stimulation (SCS) may provide pain relief for phantom limb pain (PLP), but the evidence is mixed based on a systematic review of 12 studies.

Due to the small number of patients in each study, more research is necessary to confirm the effectiveness of SCS as a treatment for PLP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review on the treatment of phantom limb pain with spinal cord stimulation. Aiyer, R., Barkin, RL., Bhatia, A., et al.[2018]

Paddle lead spinal cord stimulation (SCS) is a safe option for morbidly obese patients, with a low complication rate of 4% for infections and 13% for superficial wound dehiscence, and no neurological complications reported in a study of 67 patients.

Patients experienced a significant reduction in pain scores after the procedure, decreasing from an average of 7.9 preoperatively to 5.7 postoperatively, indicating that SCS can effectively alleviate chronic pain in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Paddle Lead Spinal Cord Stimulation in the Morbidly Obese Patient Population: Outcomes and Complications in a Single-Surgeon Cohort. Bharthi, R., Rogowski, BC., Moran, M., et al.[2023]

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]

Spinal cord stimulation (SCS) has been successfully used to treat phantom limb pain (PLP) and critical lower limb ischemia in three patients, resulting in a 50% reduction in pain for both limbs after treatment.

The therapy showed promising outcomes, including increased transcutaneous oxygen levels and a significant decrease in opioid use, suggesting SCS can be an effective option when traditional medical therapies fail.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spinal Cord Stimulation Therapy for the Treatment of Concomitant Phantom Limb Pain and Critical Limb Ischemia. De Caridi, G., Massara, M., Serra, R., et al.[2022]

In a study of 35 patients who underwent spinal cord stimulator (SCS) paddle removal, the procedure was performed safely with a low complication rate, reporting only two cases of superficial infections that were easily treated with antibiotics.

The use of neuromonitoring and fluoroscopy during the procedure contributed to the minimal risk, demonstrating that SCS paddle removal can be effectively managed with careful surgical techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Techniques for Safe Removal of Spinal Cord Stimulation Paddle Leads. Topp, G., Harland, T., Spurgas, M., et al.[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]

Citations

1. bostonscientific.com bostonscientific.com/en-US/medical-specialties/pain-management/scs-clinical-data.html

Spinal Cord Stimulation (SCS) Clinical Data Unmatched clinical data supporting SCS. Boston Scientific's multiple mechanism SCS therapy is proven by 4 Level I RCTs and 4 Real-world Studies.

2. bostonscientific.com bostonscientific.com/en-EU/products/spinal-cord-stimulator-systems/wavewriter-alpha-scs/scs-clinical-data.html

Spinal Cord Stimulation (SCS) Clinical Data LUMINA REAL-WORLD STUDY. Using the Illumina 3D™ Algorithm, paresthesia-based SCS provides EXCELLENT PAIN RELIEF. LEVEL I WHISPER RCT.

3. 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.

4. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030017S357B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The Boston Scientific Spinal Cord Stimulator Systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including ...

5. bostonscientific.com bostonscientific.com/content/dam/bostonscientific/eu/neurological-surgery/corporate-site/article-improved-outcomes-and-therapy-longevity-after-salvage.pdf

Improved Outcomes and Therapy Longevity after Salvage ... Prior to any SCS implant, the mean overall pain score (NRS) was 7.8 ± 1.9. At the time of conversion, patients had been treated with spinal cord ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf3/P030017S363B.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The SOLIS study was designed to evaluate the safety and effectiveness of Spinal Cord. Stimulation (SCS) in patients with chronic low back and/or leg pain who ...

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

Review article Spinal Cord Stimulation: An Update Spinal cord stimulation (SCS) is an adjustable, nondestructive, neuromodulatory procedure that delivers therapeutic doses of electrical current to the spinal ...