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NCT05956548
Lead Migration During the Spinal Cord Stimulation Trial Period and Therapeutic Response
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.
14 May 2024
Quick facts
| Lead sponsor | Augusta University |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 36 |
| Start date | 15 July 2023 |
| Primary completion | 14 May 2024 |
| Estimated completion | 14 July 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- external securement of scs leads during the scs trial period
Conditions studied
- Spinal Cord Stimulator Trial Period, Neuromodulation Trial Period, SCS Trial Period — all drugs for Spinal Cord Stimulator Trial Period, Neuromodulation Trial Period, SCS Trial Period →
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:
- PubMed search for NCT05956548
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05956548 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Augusta University
- Last refreshed: 21 July 2023
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