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Lead Migration During the Spinal Cord Stimulation Trial Period and Therapeutic Response

NCT05956548 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-07-21

No results posted yet for this study

Summary

The goal of this clinical trial is to compare lead migration distance and therapeutic response for participants receiving a spinal cord stimulator during the trial period. Of note- scs trial period is a procedure name, not to be confused with this clinical trial study.

The main question\[s\] it aims to answer are:

* Is there a difference in migration distance and/or rate for those with external leads secured by an anchor device versus and anchor device with suture?
* How does participant activity levels during the trial period compare to migration rates? ° Does the temperature, heat index, and humidity during the trial period impact migration rates? Participants will come in for the scs trial procedure as normal. They will be asked to complete an activity survey upon return to the clinic for lead pull after the scs trial. They will also have an additional image upon return to the clinic to document lead position prior to lead pull.

Researchers will compare two groups- those with securement via anchor and those with securement via anchor and suture to see if there is an impact on therapeutic effect (percentage of pain relief) form the scs trial.

Conditions

  • Spinal Cord Stimulator Trial Period, Neuromodulation Trial Period, SCS Trial Period

Interventions

PROCEDURE

external securement of scs leads during the scs trial period

two groups- one group will have an anchor device used alone to secure the leads, the second group will have an anchor device with a suture to secure the leads

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Jeane Silva, PhD · Augusta University

  • Stephanie C Jones, Grad Student · Augusta University

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-15
Primary Completion
2024-05-14
Completion
2024-07-14

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 NCT05956548 on ClinicalTrials.gov