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

Contrasting Lead Migration During Spinal Stimulation Trial Period Against Therapeutic Response - Evaluating Securement Methods During the Trial Period

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Stimulator Trial Period, Neuromodulation Trial Period, SCS Trial Period
• Intervention / Treatment: Procedure: external securement of scs leads during the scs trial period

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephanie C Jones, Grad Student; Phone Number: 706-721-0211; Email: sjones23@augusta.edu
• Study Contact Backup: Name: Jeane Silva, PhD; Phone Number: 706-721-0211; Email: jsilva@augusta.edu

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University Health System Pain Clinic
      • Contact: Anterpreet Dua, MD; Phone Number: 706-721-8623; Email: adua@augusta.edu
      • Contact: Zhuo Sun, MD; Phone Number: 706-721-8623; Email: zsun@augusta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Adults ages 18 and over without a failed spinal stimulation trial or implant will be accepted into the study. Patients must have a diagnosis of chronic back pain and must be patients of the identified anesthesiologists and have their procedures performed at AUHS pain clinic.

Exclusion Criteria:

Patients will be excluded if they have a history of local anesthetic allergy (lidocaine), current skin infections at the procedure site, or a diagnosis of diaphoresis/ secondary hyperhidrosis (chronic over sweating).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Therapeutic Response	% of pain relief achieved by the participant during the SCS trial period	SCS trial periods are 3-6 days at our facilty.
Lead position changes (migration)	final location of the SCS leads at the end of the scs trial period, as seen on imaging	the last day of the trial period which could be day 3 up to day 6, depending on length

Collaborators and Investigators

• Sponsor: Augusta University
• Investigators: Study Chair: Jeane Silva, PhD, Augusta University; Principal Investigator: Stephanie C Jones, Grad Student, Augusta University

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2023
• Primary Completion (Estimated): May 14, 2024
• Study Completion (Estimated): July 14, 2024

Study Registration Dates

• First Submitted: July 13, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 1994689

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No