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Neurostimulation Device

Spinal Cord Stimulation for Lower Extremity Amputation (SCS-90 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

Subjects must be between the ages of 22 and 70 years old. Participants outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing.

Subjects must have used their current prosthesis for at least 6 months and achieved at least K-1 ambulator status at the time of lead placement, as determined by the Amputee Mobility Predictor.

Must not have

Subjects must not be receiving medications that affect blood coagulation.

Female subjects of childbearing age must not be pregnant or breast-feeding.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether electrical stimulation of the lumbar spinal cord and spinal nerves can provide sensory information to amputees and reduce phantom limb pain.

Who is the study for?

This trial is for lower-limb amputees aged 22-70 who are at least six months post-amputation, have been using their current prosthesis for over six months, and can walk with or without support. Pregnant women, those on blood thinners, with severe diseases, allergies to MRI contrast agents or renal failure, high hemoglobin A1c levels (>8.0 mg/dl), implanted devices not cleared for MRI (like pacemakers), immunosuppressed individuals or those in radiation-heavy professions cannot join.

What is being tested?

The study tests a spinal cord stimulator designed to provide sensory feedback and reduce phantom limb pain in lower-limb amputees. It aims to understand how electrical stimulation of the spinal nerves affects sensation quality and prosthetic control while also measuring its impact on phantom limb perception and associated pain.

What are the potential side effects?

Potential side effects may include discomfort from electrical stimulation, skin irritation where the device attaches, possible nerve injury during lead placement for the stimulator, and typical risks associated with MRIs if applicable.

Eligibility Criteria

Inclusion Criteria

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

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I am between 22 and 70 years old.

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I've used my current prosthesis for 6+ months and can walk with it.

Exclusion Criteria

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

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I am not taking any blood-thinning medications.

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I am not pregnant or breastfeeding.

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I don't have allergies to MRI dyes or severe kidney problems.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 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

Number of participants experiencing serious device-related adverse events up to 90 days following implantation

Stimulation neurophysiology thresholds to a variety of stimulus parameters

+1 more

Secondary study objectives

Limb structure

Change in phantom limb pain using the McGill Pain Questionnaire

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: Spinal cord stimulationExperimental Treatment1 Intervention

Spinal cord stimulator leads (2-3 leads) will be placed in the lumbar epidural space of lower limb amputees to determine if the patient experiences any pain reduction from spinal cord stimulation. Participants in this study receive spinal cord stimulation will be trans-tibial amputees that are at least six month post--amputation. Subjects will have varying levels of phantom limb sensation and pain, but should have no other significant neurological disorders.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spinal cord stimulator

2017

N/A

~50

0 / 5Eligibility criteria met