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Electrical Stimulation for the Treatment of Post-Amputation Pain Using the SPRINT System

NCT01996254 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2020-03-26

Study results available
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Summary

The purpose of this study is to determine if electrical stimulation (small levels of electricity) can safely and effectively reduce post-amputation pain. This study involves a device called the SPRINT System. The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).

Conditions

  • Post-Amputation Pain
  • Phantom Limb Pain
  • Residual Limb Pain

Interventions

DEVICE

SPRINT Peripheral Nerve Stimulation (PNS) System

The SPRINT System is an Investigational Device which delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a "Lead") that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator).

Sponsors & Collaborators

  • NDI Medical, LLC

    collaborator INDUSTRY

  • United States Department of Defense

    collaborator FED

  • SPR Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Josh Boggs, PhD · SPR Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2019-01-28
Completion
2019-01-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01996254 on ClinicalTrials.gov