RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-07-15
Study Completion:2024-07-14
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05956548

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Stephanie C Jones, Grad Student
CONTACT
706-721-0211
sjones23@augusta.edu
Jeane Silva, PhD
CONTACT
706-721-0211
jsilva@augusta.edu

Principal Investigator

Jeane Silva, PhD
STUDY_CHAIR
Augusta University
Stephanie C Jones, Grad Student
PRINCIPAL_INVESTIGATOR
Augusta University

Study Locations (Sites)

Augusta University Health System Pain Clinic
Augusta, Georgia, 30912
United States

Collaborators and Investigators

Sponsor: Augusta University

  • Jeane Silva, PhD, STUDY_CHAIR, Augusta University
  • Stephanie C Jones, Grad Student, PRINCIPAL_INVESTIGATOR, Augusta University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-15
Study Completion Date2024-07-14

Study Record Updates

Study Start Date2023-07-15
Study Completion Date2024-07-14

Terms related to this study

Additional Relevant MeSH Terms

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