Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain (SENSE SCS)

January 12, 2026 updated by: MedtronicNeuro

Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain (SENSE SCS Clinical Study)

Medtronic, Inc. is sponsoring the SENSE SCS clinical study, a prospective, multi-center, post-market, non-randomized, observational study with a hybrid decentralized model of execution, utilizing a mobile application for the collection of patient reported outcomes (PROs). The purpose of the study is to evaluate workflow of a mobile application for collection of PROs and to gather data on patient experience with spinal cord stimulation therapy.

Study Overview

Status

Status

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

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.
Observational

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.
91

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
    • California
      • Carlsbad, California, United States, 92009
        • Coastal Research Institute
    • Florida
      • Fort Myers, Florida, United States, 33907
        • Pain Management Consultants of Southwest Florida
    • Minnesota
      • Edina, Minnesota, United States, 55439
        • Twin Cities Pain Clinic
    • New Jersey
      • Clifton, New Jersey, United States, 07013
        • Garden State Pain and Orthopedics
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Health Spine Specialists
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73134
        • Oklahoma Pain Management
    • Pennsylvania
      • Sewickley, Pennsylvania, United States, 15143
        • Pain Diagnostics and Interventional Care
    • Texas
      • Grapevine, Texas, United States, 76051
        • North Texas Orthopedics and Spine Center
      • San Antonio, Texas, United States, 78235
        • The San Antonio Orthopaedic Group
      • Shenandoah, Texas, United States, 77384
        • Procura Pain and Spine PLLC

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

Sampling Method

Non-Probability Sample

Study Population

The intended study population is adults with chronic, intractable pain of the trunk and/or limbs indicated to receive a Medtronic SCS system. Study eligibility criteria must be met to participate in this study.

Description

Pilot Phase Inclusion Criteria:

  1. 18 years of age or older
  2. A clinical decision was made for the patient to receive a commercial Medtronic SCS system (trial and implant) limited to the components for an on-label indication prior to enrollment in the study. NOTE: Vectris™ SureScan™ MRI 1x8 subcompact and Specify™SureScan™ MRI 2x8 leads are not eligible system components
  3. Able to differentiate between pain associated with the indication for SCS implant and other types of pain, as determined by the Investigator or designee
  4. Willing and able to use a personal smart phone for study surveys. NOTE: All subjects participating in the study must be willing to download the InsightPro™ clinical trial app and maintain current software updates on their own smart phone.
  5. Willing and able to provide signed and dated informed consent in English
  6. Willing and able to comply with all study procedures and visits

Pilot Phase Exclusion Criteria:

  1. Any active implantable neuromodulation device or system (e.g., Peripheral Nerve Stimulation, Sacral Neuromodulation)
  2. Currently participating, or plans to participate, in another investigational study or has a planned major medical procedure that may interfere with study procedures or confound study results, as determined by the Investigator or designee, unless documented pre-approval is provided by the sponsor
  3. Major untreated or refractory psychiatric comorbidity or other progressive disease (e.g., neurodegenerative disease, heart failure, cancer) that may confound study results, as determined by the Investigator or designee
  4. Serious drug-related behavioral issues (e.g., alcohol dependency, illegal substance abuse), as determined by the Investigator or designee
  5. Pregnant or planning on becoming pregnant
  6. Involved in an injury claim under current litigation, beneficiary of an injury claim, or receiving worker's compensation
  7. Patients with buried lead trials/implants will be excluded from this study

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Pilot Phase Cohort
Device: Commercially available neurostimulation systems
Spinal cord stimulation therapy delivered during trialing and following implant of commercially available neurostimulation systems
Data at Scale Phase Cohort
Device: Commercially available neurostimulation systems
Spinal cord stimulation therapy delivered during trialing and following implant of commercially available neurostimulation systems

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
Percentage of surveys completed from Baseline through the SCS Trial Period in the Pilot Phase Cohort.
Time Frame: Up to 28 days
The percentage of surveys with complete data collected via the InsightPro™ clinical trial app from Baseline through the SCS Trial Period, calculated as the number of surveys with complete data divided by the total number of expected surveys within the Pilot Phase Cohort, expressed as a percentage.
Up to 28 days
Rating on the 7-point scale of Patient Global Impression of Change (PGIC) at Month 3 in the Data at Scale Phase Cohort
Time Frame: Month 3
PGIC is a single question asking the subject to rate their improvement in pain condition on a 7-point scale from 1 (Very Much Improved) to 7 (Very Much Worse)
Month 3

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.
MedtronicNeuro

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.
  • Study Director: Mirit Argov, Medtronic

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.
April 25, 2023

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.
May 29, 2025

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.
May 29, 2025

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).
February 17, 2023

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.
March 16, 2023

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.
March 20, 2023

Study Record Updates

Last Update Posted (Estimated)

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.
January 14, 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.
January 12, 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.
January 1, 2026

More Information

Terms related to this study

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.
  • MDT22020

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.

Yes

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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