Spinal Cord Stimulation for Restoration of Function in Lower-Limb Amputees, 90-Day

NCT04547582 | Terminated Results DMC FDA Device

• 2 other identifiers: STUDY190100191UH3NS100541-01A1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

The goals of this study are to provide sensory information to amputees and reduce phantom limb pain via electrical stimulation of the lumbar spinal cord and spinal nerves. The spinal nerves convey sensory information from peripheral nerves to higher order centers in the brain. These structures still remain intact after amputation and electrical stimulation of the dorsal spinal nerves in individuals with intact limbs and amputees has been demonstrated to generate paresthetic sensory percepts referred to portions of the distal limb. Further, there is recent evidence that careful modulation of stimulation parameters can convert paresthetic sensations to more naturalistic ones when stimulating peripheral nerves in amputees. However, it is currently unclear whether it is possible to achieve this same conversion when stimulating the spinal nerves, and if those naturalistic sensations can have positive effects on phantom limb pain. As a first step towards those goals, in this study, the investigators will quantify the sensations generated by electrical stimulation of the spinal nerves, study the relationship between stimulation parameters and the quality of those sensations, measure changes in control of a prosthesis with sensory stimulation, and quantify the effects of that stimulation on the perception of the phantom limb and any associated pain.

Conditions

Traumatic Amputation of Lower Extremity; Phantom Limb Pain

Keywords

Phantom Limb Pain; Lower-Limb Amputation; electrodes; stimulation; BKA; pain; sensation

Outcome Measures

Primary Outcomes (5)

• Number of Participants Experiencing Serious Device-related Adverse Events up to 90 Days Following Implantation

  Investigators will track the number of participants experiencing serious device-related adverse events, such as unresolved superficial infection resulting in lead removal, deep infection, inpatient hospitalization, withdrawal from the study due to worsening pain or intolerable dysesthesia, or fracture due to falls related to the study interventions, that occur during the course of and up to 90 days following implantation.

  90 days

• Minimum Amplitude of Pulse Required to Evoke Sensory Percepts

  Quantify the threshold stimulus required to evoke sensory percepts during epidural spinal nerve stimulation.

  90 days

• Minimum Charge Required to Evoke a Neurophysiological Response

  Quantify the threshold (minimum charge) stimulus required to evoke neurophysiological responses during epidural spinal nerve stimulation

  90 days

• Location of Evoked Sensation - Missing Toes

  Participants reporting sensation on missing toes from spinal cord stimulation.

  90 days

• Location of Evoked Sensation - Plantar Surface of Missing Foot

  Participants perceiving sensation on the plantar surface of missing foot

  90 days

Secondary Outcomes (3)

• Change in Phantom Limb Pain Using the McGill Pain Questionnaire

  Pre-implant (baseline), Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and post-explant (90 days)

• Qualitative Self-report of Evoked Sensations

  90 days

• Able to Use a Prosthetic Limb With Neural Signals

  90 days

Study Arms (1)

Spinal cord stimulation

EXPERIMENTAL

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.

Device: Spinal cord stimulator

Interventions

Spinal cord stimulator DEVICE

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.

Spinal cord stimulation

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must be over 6 months post-amputation at the time of lead placement.
• 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.

You may not qualify if:

• Subjects must not have any serious disease or disorder that could affect their ability to participate in this study.
• Female subjects of childbearing age must not be pregnant or breast-feeding.
• Subjects must not be receiving medications that affect blood coagulation.
• Subjects must not have an allergy to contrast medium or renal failure that could be exacerbated by the contrast agent used in MRIs. For this study, renal insufficiency will be determined through blood work and defined as BUN of 30 or less and Creatinine of 1.5 or less.
• Subjects may not have a hemoglobin A1c level above 8.0 mg/dl at time of implant.
• Subjects may not have any implanted medical devices that are not cleared for MRI.
• Subjects with a T-Score higher than 63 on the 18-question Brief Symptoms Inventory (BSI-18) who have undergone discussions with and been deemed unsuitable by the Principal Investigator, a study physician, and a psychologist
• Subjects may not have a cardiac pacemaker.
• Subjects may not have a cardioverter defibrillator.
• Subjects may not be currently receiving diathermy therapy.
• Subjects may not have an implanted infusion pump.
• Subjects may not be immunosuppressed or currently receiving immunosuppressive medications.
• Subjects may not have a profession (e.g. radiology technologist) or medical condition (e.g. remissory cancer involved regular follow-up x-rays) that would increase radiation exposure in the 12 months prior to starting or after ending participation in the study.

Sponsors & Collaborators

• Lee Fisher, PhD: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Phantom Limb; Pain

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Results Point of Contact

• Title: Dr. Lee Fisher, PhD
• Organization: University of Pittsburgh

lef44@pitt.edu

412-383-1326

Study Officials

• Lee E Fisher, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 7, 2020
• First Posted: September 14, 2020
• Study Start: May 27, 2021
• Primary Completion: July 3, 2023
• Study Completion: July 3, 2023
• Last Updated: January 7, 2026
• Results First Posted: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Data will be shared according to guidelines in data sharing agreements.
• Access Criteria: We will share with our sponsor and collaborators.

Locations

US (1)