CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
SPRINT Peripheral Nerve Stimulation (PNS) Systemdevice
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/NCT01996254
NCT01996254N/ACompleted
CompareCT.gov

A Randomized, Double-Blinded, Placebo-Controlled, Multicenter Pilot Study of the SPRINT Peripheral Nerve Stimulation (PNS) System for the Treatment of Post-Amputation Pain

SPR Therapeutics, Inc.·interventional·Posted Nov 27, 2013·Updated Mar 26, 2020

In Brief

A clinical study evaluating SPRINT Peripheral Nerve Stimulation (PNS) System for Post-Amputation Pain and 2 related conditions. Completed, enrolled 28 participants across 10 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost-Amputation Pain, Phantom Limb Pain, Residual Limb Pain
CountriesUnited States
CollaboratorsNDI Medical, LLC, United States Department of Defense

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedNov 27, 2013
Enrollment StartOct 1, 2013
Primary CompletionJan 28, 2019
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 12.6 years ago

Interventions

SPRINT Peripheral Nerve Stimulation (PNS) Systemdevice

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).