The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

Chronic Pain Clinical Trial

Official title:

The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05741788
• Other study ID #: Teaspoon
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2026

Study information

• Verified date: November 2023
• Source: University of Minnesota
• Contact: David Darrow, MD
• Phone: 612-624-6666
• Email: darro015[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Spinal Cord Injuries

Intervention

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 phenotype.

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Feasibility as measured by total study procedure completion rate.	3 years
Secondary	Acceptability of procedure	Acceptability as measured by the average patient rating and their acceptability of the study based on their experience during the procedures across study procedures. Participants rate their overall experience with the procedures used during the study on a scale from 0 as 'Excellent' to 4 as 'Very Poor'.	3 years