Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

March 4, 2026 updated by: Scott Lempka, University of Michigan

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Burst / kHz / Sham / Tonic
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.
Device: Spinal cord stimulation
The spinal cord stimulation (SCS) system will be programmed to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: Burst / Sham / kHz / Tonic
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.
Device: Spinal cord stimulation
The spinal cord stimulation (SCS) system will be programmed to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: kHz / Sham / Burst / Tonic
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.
Device: Spinal cord stimulation
The spinal cord stimulation (SCS) system will be programmed to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: kHz / Burst / Sham / Tonic
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.
Device: Spinal cord stimulation
The spinal cord stimulation (SCS) system will be programmed to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: Sham / Burst / kHz / Tonic
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.
Device: Spinal cord stimulation
The spinal cord stimulation (SCS) system will be programmed to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: Sham / kHz / Burst / Tonic
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.
Device: Spinal cord stimulation
The spinal cord stimulation (SCS) system will be programmed to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS)
Time Frame: Up to 30 days
TS refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimuli trials. If the difference is a positive number, the researchers will conclude that there was pain summation, where larger numbers will indicate increased pain summation or TS. If the difference is zero or a negative number, the researchers will conclude that there was no pain summation or TS.
Up to 30 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
SCS-induced Changes in Temporal Summation (TS) - 50Hz (Tonic)-SCS to Sham-SCS
Time Frame: Up to 30 days
Temporal summation (TS) refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimulus trials. TS scores range from a minimum of -100 to a maximum of 100. If the difference was a positive number, then pain summation was present, where larger numbers indicate increased pain summation or TS. If the difference was zero or a negative number, then no pain summation or TS was present. Results show in-participant comparisons calculated as the Tonic-SCS score minus the Sham-SCS score for each individual across the entire study, regardless of sequence. Negative values indicate improvement (i.e., reduced pain summation or TS with Tonic-SCS relative to Sham-SCS) and positive values indicate worsening (i.e., increased pain summation or TS with Tonic-SCS relative to Sham-SCS).
Up to 30 days
SCS-induced Changes in Temporal Summation (TS) - 1kHz-SCS to Sham-SCS
Time Frame: Up to 30 days
Temporal summation (TS) refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimulus trials. The TS scores range from a minimum of -100 to a maximum of 100. If the difference was a positive number, then pain summation was present, where larger numbers indicate increased pain summation or TS. If the difference was zero or a negative number, then no pain summation or TS was present. Results show in-participant comparisons calculated as the kHz-SCS score minus the Sham-SCS score for each individual across the entire study, regardless of sequence. Negative values indicate improvement (i.e., reduced pain summation or TS with kHz-SCS relative to Sham-SCS) and positive values indicate worsening (i.e., increased pain summation or TS with kHz-SCS relative to Sham-SCS).
Up to 30 days
Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS) - Burst-SCS to Sham-SCS
Time Frame: Up to 30 days
Temporal summation (TS) refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores were calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimulus trials. TS scores range from a minimum of -100 to a maximum of 100. If the difference was a positive number, then pain summation was present, where larger numbers indicate increased pain summation or TS. If the difference was zero or a negative number, then no pain summation or TS was present. Results show in-participant comparisons calculated as the Burst-SCS score minus the Sham-SCS score for each individual across the entire study, regardless of sequence. Negative values indicate improvement (i.e., reduced pain summation or TS with Burst-SCS relative to Sham-SCS) and positive values indicate worsening (i.e., increased pain summation or TS with Burst-SCS relative to Sham-SCS).
Up to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Center for Complementary and Integrative Health (NCCIH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Scott Lempka, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 18, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 18, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00164430
  • R01AT010817 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share IPD at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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