NCT05956548

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Augusta University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-07-15
• Primary completion: 2024-05-14
• Completion: 2024-07-14
• First posted: 2023-07-21
• Last updated: 2023-07-21

Locations

1 site across 1 country: United States