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Spinal Cord Stimulation for Phantom Limb Pain (PhantomLimb Trial)

N/A

Recruiting

Led By Lee E Fisher, PhD

Research Sponsored by Lee Fisher, PhD

Eligibility Criteria Checklist

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

Must have

Have an upper-limb amputation

Be at least one year post-amputation

Must not have

Must not be currently taking any medications that thin your blood

Women who are pregnant or plan to become pregnant during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a treatment for pain caused by amputation by electrical stimulation of the nerves in the spinal cord.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly stated, potential side effects may include discomfort at the electrode site, skin irritation, infection risk from implantation, and possible changes in sensation or pain levels during or after stimulation.

Eligibility Criteria

Inclusion Criteria

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

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I have an amputation above the wrist.

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It has been over a year since my amputation.

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I am between 18 and 70 years old.

Exclusion Criteria

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

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I am not taking blood thinners.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 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

Stimulation thresholds to a variety of stimulus parameters

Secondary study objectives

Pain

Location and modality of evoked sensory percepts

Qualitative self-report of evoked sensations

+1 more

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: Boston Scientific cord stimulator leadExperimental Treatment1 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.

0 / 5Eligibility criteria met