Recruiting

Spinal Cord Stimulation

Sponsor:

University of Minnesota

Code:

NCT05741788

Conditions

Spinal Cord Injuries

Chronic Pain

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

Interventions

Various Stimulation Patterns

Study Details

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

Study ID

NCT05741788

Start date

Oct 1, 2023

Status verified date

Sep, 2026

Completion date

Oct 1, 2028

Anticipated

Primary completion date

Oct 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 22+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental group

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

Interventions

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.

Primary outcome measure

  • Feasibility [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

More Information

Sponsor

University of Minnesota

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-09-03.