CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 4 enrolled
Drug / intervention
Boston Scientific Stimulator Leaddevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02684201
NCT02684201N/ACompleted

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

Lee Fisher, PhD·interventional·Posted Feb 17, 2016·Updated Oct 8, 2025

In Brief

A clinical study evaluating Boston Scientific Stimulator Lead for Phantom Limb. Completed, enrolled 4 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPhantom Limb
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 17, 2016
Enrollment StartNov 1, 2015
Primary CompletionAug 1, 2024
TodayJul 2, 2026
Enrollment to primary: 8.8 yearsPosted 10.4 years ago

Interventions

Boston Scientific Stimulator Leaddevice

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.