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NCT Number: NCT05741788

The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

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.

Recruiting

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Key information

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

David Darrow, MD

CONTACT

[email protected]

612-624-6666

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility

    Time frame: 3 years

    Feasibility as measured by total study procedure completion rate.

Secondary outcomes

  1. Acceptability of procedure

    Time frame: 3 years

    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'.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexander Herman, MD

CONTACT

[email protected]

(612) 624-2867

David Darrow, MD

CONTACT

[email protected]

612-624-6666

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Feb 23, 2023
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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