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

NCT02684201 | Completed Results DMC

• 1 other identifier: STUDY19100220
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with upper-limb amputation usually have intact nerves within the residual limb, and studies have demonstrated that electrical stimulation of those nerves can produce sensations that appear to emanate from the amputated limb. In this study, investigators will examine the sensations that are produced by electrical stimulation of these nerves at the location where they exit the spinal cord. Stimulation of the spinal cord is commonly used to treat intractable back and limb pain, and the procedure includes a test phase in which electrodes are temporarily placed under the skin near the spinal cord and removed at the end of testing. Similarly, in this study, electrodes will be placed near the spinal cord in the upper back and neck, and stimulation will be applied over the course of multiple testing sessions, lasting less than 30 days. The electrodes will be removed at the last day of testing. During each testing session, electrical stimulation will be applied through the electrodes and a series of tests will be performed to determine the types of sensations produced by stimulation. In addition to producing meaningful sensations with electrical stimulation, this study will also test the effect of stimulation on phantom limb sensations and phantom limb pain.

Conditions

Phantom Limb

Keywords

Phantom Limb; Upper Amputee; Electrodes; Implant; Pain

Outcome Measures

Primary Outcomes (5)

• Stimulation Thresholds to a Variety of Stimulus Parameters

  Quantify the threshold (minimum charge) stimulus required to evoke sensation and neurophysiological responses during epidural spinal nerve stimulation, and monitor changes in those percepts and responses over time.

  30 days

• Week 1 Average Stimulus Charge for All Subjects

  The average stimulus (nC) required to evoke sensation during week 1 of implant duration.

  first 7 days of implant

• Week 2 Average Stimulus Charge for All Subjects

  The average stimulus (nC) required to evoke sensation during week 2 of implant duration.

  During days 7-14 of implant

• Week 3 Average Stimulus Charge for All Subjects

  The average stimulus (nC) required to evoke sensation during week 3 of implant duration.

  During days 15 to 21 of implant

• Week 4 Average Stimulus Charge for All Subjects

  The average stimulus (nC) required to evoke sensation during week 4 of implant duration.

  During days 22-28 of implant

Secondary Outcomes (5)

• Number of Participants Who Were Able to Discern Specific Regions of the Spinal Cord That Evoked Sensations

  30 days

• Qualitative Self-report of Evoked Sensations

  30 days

• Change in Pain Ratings After Study Completion

  30 days

• Success Rate During Control of Prosthetic Hand to Identify Object Size

  30 days

• Success Rate During Control of Prosthetic Hand to Identify Object Compliance (Soft, Medium, Hard)

  30 days

Study Arms (1)

Boston Scientific cord stimulator lead

EXPERIMENTAL

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.

Device: Boston Scientific Stimulator Lead

Interventions

Boston Scientific Stimulator Lead DEVICE

A Boston Scientific (PMA P030017) spinal cord stimulator lead will be placed in the cervical epidural space of ten upper-limb amputees and steered laterally towards the dorsal spinal roots under fluoroscopic guidance.

Boston Scientific cord stimulator lead

Eligibility Criteria

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

You may qualify if:

• have an upper-limb amputation
• must be between the ages of 18 and 70
• be at least one year post-amputation
• be willing to travel to the University of Pittsburgh at least twice per week for 29 days

You may not qualify if:

• women who are pregnant or plan to become pregnant during the study
• all participants cannot have any serious diseases or disorders that affect your ability to participate in this study
• must not be currently taking any medications that thin your blood

Sponsors & Collaborators

• Lee Fisher, PhD: lead

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

412-383-1077

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: PhD, Assistant Professor

Study Record Dates

• First Submitted: November 11, 2015
• First Posted: February 17, 2016
• Study Start: November 1, 2015
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: October 8, 2025
• Results First Posted: October 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Study information will be shared with the study sponsor through the duration of the grant.
• Access Criteria: Data will be shared with the sponsor and/or collaborators per the stipulations of the grant and/or data sharing agreements.

Locations

US (1)