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NCT03718325 · ClinicalTrials.gov registry record · NA

Burst Spinal Cord Stimulation (Burst-SCS) Study

A NA study, sponsored by University of Michigan.

Terminated
Registry status
NA
Development phase
12
Enrollment target

NCT03718325: Clinical Trial NA study, sponsored by University of Michigan.

NCT03718325 is a NA study that was terminated before completion, run by University of Michigan. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03718325, a NA study, was terminated before completion, sponsored by University of Michigan.

TERMINATED
Registry status
NA
Development phase
12 participants
Enrollment target

Study Summary

Recently a new form of spinal cord stimulation therapy called burst spinal cord stimulation (Burst-SCS) is available to treat chronic pain. The goal of this study is to learn more about how Burst-SCS works to reduce chronic pain. The study will examine chronic pain patients who have been deemed candidates for Burst-SCS therapy, and who have already been selected to receive a temporary externalized trial of Burst-SCS from their own doctors as part of their standard clinical care for chronic pain management. During the study, participants will be asked to complete a variety of evaluations at certain time points. In addition, there will be a randomized, double blind, crossover phase, where the particular effects of Burst-SCS and sham SCS will be evaluated. The device used to deliver Burst-SCS and sham SCS is the St. Jude Medical Invisible Trial System.

Primary Outcome

Visual analog scale (VAS) was a horizontal line 100 millimeters (mm) in length with the word "no pain" and "worst possible pain" printed below. The participant marked on the line the point that they felt represented their perception of their current state. The score was determined by measuring in millimeters from the left hand with a total range of 0-100 millimeters, with a score between 0 (no pain) to a score of 100 (worst possible pain). Higher VAS values represented more severe pain and lower

Interventions

  • DEVICE Burst-SCS
  • DEVICE Sham SCS

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2019-03-12
Est. Completion 2020-03-10
Phase NA
University of Michigan

1,327 total trials

Why NCT03718325 stopped before completion

NCT03718325 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Burst-SCS is the first listed.

NCT03718325 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03718325 about?

NCT03718325 is a clinical study titled "Burst Spinal Cord Stimulation (Burst-SCS) Study". Recently a new form of spinal cord stimulation therapy called burst spinal cord stimulation (Burst-SCS) is available to treat chronic pain. The goal of this study is to learn more about how Burst-SCS works to reduce chronic pain. The study will examine chronic pain patients who have been deemed cand...

What is the current status of trial NCT03718325?

This trial is currently terminated. It is a NA study. The enrollment target is 12 participants. The study started on 2019-03-12. Estimated completion is 2020-03-10.

What interventions are being tested in trial NCT03718325?

The interventions under investigation include: Burst-SCS (DEVICE), Sham SCS (DEVICE).

Who is sponsoring clinical trial NCT03718325?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03718325's enrollment target sits among peer trials

12 1913th of 2000 higher than 74 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03718325, the US trial registry maintained by the National Library of Medicine. NCT03718325 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.