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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights

PhantomLimb Trial 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.Check my eligibility
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.See study design
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.

PhantomLimb Trial 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.

PhantomLimb Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Stimulation thresholds to a variety of stimulus parameters
Secondary outcome measures
Pain
Location and modality of evoked sensory percepts
Qualitative self-report of evoked sensations
+1 more

PhantomLimb 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.

Find a Location

Who is running the clinical trial?

Lee Fisher, PhDLead Sponsor
3 Previous Clinical Trials
55 Total Patients Enrolled
University of PittsburghLead Sponsor
1,731 Previous Clinical Trials
16,307,138 Total Patients Enrolled
Lee E Fisher, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Boston Scientific Stimulator Lead (Other) Clinical Trial Eligibility Overview. Trial Name: NCT02684201 — N/A
Phantom Limb Syndrome Research Study Groups: Boston Scientific cord stimulator lead
Phantom Limb Syndrome Clinical Trial 2023: Boston Scientific Stimulator Lead Highlights & Side Effects. Trial Name: NCT02684201 — N/A
Boston Scientific Stimulator Lead (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02684201 — N/A
~1 spots leftby Oct 2025
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