The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

NCT05741788 | Recruiting

• 1 other identifier: Teaspoon
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Feasibility

  Feasibility as measured by total study procedure completion rate.

  3 years

Secondary Outcomes (1)

• Acceptability of procedure

  3 years

Study Arms (1)

Experimental group

EXPERIMENTAL

Prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy.

Device: Various Stimulation Patterns

Interventions

Various Stimulation Patterns DEVICE

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.

Experimental group

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries; Chronic Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• David Darrow, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Darrow, MD

CONTACT

612-624-6666; darro015@umn.edu

Alexander Herman, MD

CONTACT

(612) 624-2867; herma686@umn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 23, 2023
• Study Start: October 1, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)