The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

Sponsor

University of Minnesota (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05741788

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Chronic Pain	Device: Various Stimulation Patterns	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

Anticipated Study Start Date :

Mar 13, 2023

Anticipated Primary Completion Date :

Mar 13, 2025

Anticipated Study Completion Date :

Mar 13, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Experimental group Prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy.	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.

Arm

Intervention/Treatment

Experimental: Experimental group

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

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.

Outcome Measures

Primary Outcome Measures

Feasibility [3 years]
Feasibility as measured by total study procedure completion rate.

Secondary Outcome Measures

Acceptability of procedure [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'.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55414

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator: David Darrow, MD, University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Minnesota

ClinicalTrials.gov Identifier:

NCT05741788

Other Study ID Numbers:

Teaspoon

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 23, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Spinal Cord Injuries

Chronic Pain

Study Results

No Results Posted as of Feb 23, 2023