Last reviewed · How we verify

NCT05956548

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

Status unknown NA Last updated 21 July 2023
What this trial tests

NA trial testing external securement of scs leads during the scs trial period in Spinal Cord Stimulator Trial Period, Neuromodulation Trial Period, SCS Trial Period in 36 participants. Status unknown.

Timeline
15 July 2023
Primary endpoint
14 May 2024
14 July 2024

Quick facts

Lead sponsorAugusta University
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment36
Start date15 July 2023
Primary completion14 May 2024
Estimated completion14 July 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Augusta University

Who can join

18 and older, any sex, with Spinal Cord Stimulator Trial Period, Neuromodulation Trial Period, SCS Trial Period. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other Augusta University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05956548.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing