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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 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

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.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Lee Fisher, PhDLead Sponsor

3 Previous Clinical Trials

55 Total Patients Enrolled

University of PittsburghLead Sponsor

1,720 Previous Clinical Trials

16,342,801 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate amount of participants enrolled in this clinical trial?

"Affirmative. Clinicaltrials.gov documents show that the trial, initially posted on November 1st 2015, is currently recruiting participants. Only 10 patients are required at a single medical institution."

Answered by AI

Are there any vacancies for those seeking to participate in this clinical experiment?

"Research posted to clinicaltrials.gov indicates that this medical trial is actively recruiting patients, having first appeared on the 1st of November 2015 and most recently updated on the 11th of April 2022."

Answered by AI

Is this clinical evaluation offering enrollment to seniors aged 85 or above?

"The upper age limit for enrolment in this trial is 70 years, with the lowest being 18."

Answered by AI

Who meets the stipulations to take part in this trial?

"The University of Pittsburgh is currently enrolling 10 participants aged between 18 and 70 with phantom limb syndrome. In addition to these prerequisites, the ideal candidate must have had an upper-limb amputation at least a year prior, as well as be willing to travel back and forth twice weekly for 29 days."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Epidural Spinal Cord Stimulation for Sensory Restoration and Phantom Limb Pain in Upper-Limb Amputees

Lee Fisher, PhD 2015. "Epidural Spinal Cord Stimulation for Sensory Restoration and Phantom Limb Pain in Upper-Limb Amputees". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02684201.

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