The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain
Recruiting now · Not applicable
Conditions studied: Spinal Cord Injuries, Chronic Pain
In brief
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.
Key facts
- Study ID
- NCT05741788
- Run by
- University of Minnesota
- People needed
- 15
- Starts
- 2023-10-01
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2025-10-02
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 22 years of age or older
- Scheduled to undergo spinal cord stimulation
- English speaker
- Baseline pain rating (NRS/VAS) >=6
You may not qualify if…
- 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
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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