CRCNS: Model-based Characterization of Spinal Cord Stimulation for Pain

University of Michigan1 site in 1 country34 target enrollmentStarted: September 11, 2021Last updated: March 27, 2026

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: University of Michigan
Enrollment: 34
Locations: 1
Primary Endpoint: Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS)

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

Doctors sometimes treat chronic pain with devices that send mild electrical currents into the spinal cord. This type of treatment is referred to as neurostimulation. A common form of neurostimulation therapy is spinal cord stimulation (SCS). In this study, how SCS affects pain processing and relieves pain will be studied. Multiple forms of SCS will be examined in chronic pain patients who are receiving SCS from their own doctors as part of their standard of care. During the study, participants will be asked to complete a variety of evaluations at certain time points.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Treatment
Masking: Double (Participant, Outcomes Assessor)

Masking Description

There will be two research teams. One team will be unblinded (e.g., clinical care provider/company representative, study coordinator) and will perform stimulator programming/adjustment, and the other team will be blinded (e.g., research personnel) and will perform clinical testing and collect study outcome measures.

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•Chronic intractable pain of the trunk and/or limbs
•Undergoing SCS as part of standard clinical care for chronic pain management
•Candidates will have been implanted with a commercial SCS device
•Candidates who are 18 years or older and can speak, read, and understand English
•Able to understand study procedures and to comply with them for the entire length of the study
•Must be willing to participate in COVID-19 symptom screening and answer questions about COVID-19 diagnosis 1-3 days before a scheduled visit
•Must be willing to wear a face-covering during all study visits

Exclusion Criteria

•Subjects who are pregnant or nursing
•Subjects with current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail
•Subjects who are unable or unwilling to cooperate with clinical testing
•Subjects having any impairment, activity or situation that in the judgment of study personnel would prevent satisfactory completion of the study protocol
•Inability or unwillingness of individual or legal guardian/representative to give written informed consent
•Subjects who currently have or tested positive in the last 14 days for COVID-19, or are symptomatic for COVID-19

Arms & Interventions

Burst / kHz / Sham / Tonic

Experimental

Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.