The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Various Stimulation Patterns.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injuries, Chronic Pain. Basic parameters: from 22 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Various Stimulation Patterns
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. Participants will follow up routinely to collect laboratory, behavioral, and survey responses to test for the feasibility of obtaining data explaining pain phenoty
Primary outcome measures
- Feasibility [Time frame: 3 years]
Secondary outcome measures (1)
- Acceptability of procedure [Time frame: 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Minnesota — Minneapolis
Identifiers
NCT: NCT05741788 · Teaspoon