NCT05741788 The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain
| NCT ID | NCT05741788 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Minnesota |
| Condition | Spinal Cord Injuries |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2023-10-01 |
| Primary Completion | 2026-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 15 participants in total. It began in 2023-10-01 with a primary completion date of 2026-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Spinal cord stimulation modulates the nervous system to effectively block pain signals originating from the back and legs. Spinal cord stimulation has been shown to improve chronic pain, improve quality of life, and reduce disability. Unfortunately, spinal cord stimulation has a high trial failure rate and a high long-term failure rate. This study consists of a prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy. Participants will undergo a structured optimization evaluating existing types of stimulation (tonic, burst, and multistim). Each participant will try out all types of available stimulation but be blinded to the type. Over the course of four months, each participant will evaluate each type of stimulation by reporting daily pain scores. Thompson sampling will be used to identify which setting produces the biggest improvement in pain and recommend it for future use. Participants will follow up routinely to collect laboratory, behavioral, and survey responses to test for the feasibility of obtaining data explaining pain phenotype.
Eligibility Criteria
Inclusion Criteria: * 22 years of age or older * Scheduled to undergo spinal cord stimulation * English speaker * Baseline pain rating (NRS/VAS) \>=6 Exclusion Criteria: * Scheduled for permanent implantation only without trial * Presence of pacemakers or other neurostimulators * Pregnant * Inability to read or use smart phone * Individuals who are unable to consent * Employees or students of PI * Prisoners
Contact & Investigator
David Darrow, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT05741788 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Spinal Cord Injuries. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05741788 currently recruiting?
Yes, NCT05741788 is actively recruiting participants. Contact the research team at darro015@umn.edu for enrollment information.
Where is the NCT05741788 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05741788 clinical trial?
NCT05741788 is sponsored by University of Minnesota. The principal investigator is David Darrow, MD at University of Minnesota. The trial plans to enroll 15 participants.