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Spinal Cord Stimulation for Phantom Limb Pain

N/A

Recruiting

Research Sponsored by Lee Fisher, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects must be undergoing an epidural spinal cord implanted electrode array clinical trial with Dr. Helm for the management of pain.

Subjects must be between the ages of 18 and 70 years old.

Must not have

Persons with open wounds

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether electrical stimulation of the spinal cord can help control pain. Investigators will ask subjects to report the types of sensations felt and perform detailed psychophysical metrics to examine participants' ability to discriminate sensations.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed, electrical stimulation may cause discomfort, skin irritation at the electrode sites, unexpected changes in sensation or pain levels, and potential interference with other electronic medical devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I currently have open wounds.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Location of evoked sensory percepts

Stimulation neurophysiology thresholds to stimulus parameters

Stimulation perceptual thresholds to stimulus parameters

Secondary study objectives

Qualitative self-report of evoked sensations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spinal cord stimulation system

2011

Completed Phase 3

~20

0 / 3Eligibility criteria met