30 Participants Needed

Spinal Cord Stimulation for Phantom Limb Pain

DH
CK
Overseen ByCasey Konopisos
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Lee Fisher, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The goal of this project is to characterize the types of sensations that can be evoked via electrical stimulation of the spinal cord and spinal nerves. Patients will be recruited from a local pain clinic, each with a spinal cord stimulation device implanted, to participate in experiments to explore the ability to modulate and control the modality, intensity, focality, and location of the sensations evoked by stimulation through the spinal cord stimulator leads. Investigators will connect spinal cord stimulator leads to a custom stimulator system and will ask subjects to report the types of sensations felt. Invesigators will also perform detailed psychophysical metrics to examine participants' ability to discriminate sensations.

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 data supports the effectiveness of the treatment Spinal Cord Stimulation for Phantom Limb Pain?

Spinal Cord Stimulation (SCS) has shown promise in reducing phantom limb pain, with some studies reporting good to excellent pain relief in most patients. For example, one study noted significant pain reduction in a patient using SCS, with pain scores dropping from 8/10 to 2/10, although some pain returned over time.12345

Is spinal cord stimulation generally safe for humans?

Spinal cord stimulation (SCS) is generally considered safe for humans, with studies showing a low rate of serious complications. In a global study, the most common serious issue was implant site infection, occurring in less than 1% of cases, and the overall rate of device removal due to problems was low.678910

How does spinal cord stimulation differ from other treatments for phantom limb pain?

Spinal cord stimulation (SCS) is unique because it involves implanting a device that delivers electrical pulses to the spinal cord, which can help reduce pain by altering nerve activity. Unlike traditional pain medications, SCS directly targets the nervous system and can be effective when other treatments fail.13111213

Research Team

LF

Lee Fisher, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.
I am between 18 and 70 years old.

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.
See 1 more

Timeline

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

Treatment Details

Interventions

  • Spinal cord stimulation system
Trial OverviewThe 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Stimulation in individuals with implanted stimulation systemsExperimental Treatment1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Lee Fisher, PhD

Lead Sponsor

Trials
4
Recruited
70+

Findings from Research

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.
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.
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]
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.
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]

References

Use of spinal cord stimulation in the treatment of phantom limb pain: case series and review of the literature. [2022]
Complete coverage of phantom limb and stump pain with constant current SCS system: a case report and review of the literature. [2018]
Spinal Cord Stimulation in The Treatment of Phantom Limb Pain: A Case Report and Review of Literature. [2022]
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. [2022]
Phantom limb pain. Treatment with dorsal column stimulation. [2007]
Rate of Complications Following Spinal Cord Stimulation Paddle Electrode Removal. [2022]
Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry. [2019]
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. [2022]
Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain. [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
The Incidence of Spinal Cord Injury in Implantation of Percutaneous and Paddle Electrodes for Spinal Cord Stimulation. [2022]
Spinal cord stimulation: Background and clinical application. [2022]
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. [2023]
Spinal cord stimulation in deafferentation pain. [2018]