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The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

Primary Purpose

Spinal Cord Injuries, Chronic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Various Stimulation Patterns
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injuries

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

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

Outcomes

Primary Outcome Measures

Feasibility
Feasibility as measured by total study procedure completion rate.

Secondary Outcome Measures

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'.

Full Information

First Posted
January 16, 2023
Last Updated
August 11, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT05741788
Brief Title
The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain
Official Title
The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2025 (Anticipated)
Study Completion Date
October 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Prospective cohort of patients clinically scheduled to undergo spinal cord stimulation for the treatment of chronic back pain or radiculopathy.
Intervention Type
Device
Intervention Name(s)
Various Stimulation Patterns
Intervention Description
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 Information:
Title
Feasibility
Description
Feasibility as measured by total study procedure completion rate.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Acceptability of procedure
Description
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'.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Darrow, MD
Phone
612-624-6666
Email
darro015@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Herman, MD
Phone
(612) 624-2867
Email
herma686@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Darrow, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55414
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Darrow, MD
Phone
612-624-6666
Email
darro015@umn.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Teaspoon Study - Telefitting Spinal Cord Stimulation for Pain

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