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

NCT05775510 | Terminated FDA Device

• 1 other identifier: MDT22020
• Study Type: observational
• Target: 91
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Pain, Intractable; Pain, Chronic

Outcome Measures

Primary Outcomes (2)

• Percentage of surveys completed from Baseline through the SCS Trial Period in the Pilot Phase Cohort.

  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

  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

Study Arms (2)

Pilot Phase Cohort

Device: Commercially available neurostimulation systems

Data at Scale Phase Cohort

Device: Commercially available neurostimulation systems

Interventions

Commercially available neurostimulation systems DEVICE

Spinal cord stimulation therapy delivered during trialing and following implant of commercially available neurostimulation systems

Data at Scale Phase Cohort; Pilot Phase Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• years of age or older
• 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
• Able to differentiate between pain associated with the indication for SCS implant and other types of pain, as determined by the Investigator or designee
• 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.
• Willing and able to provide signed and dated informed consent in English
• Willing and able to comply with all study procedures and visits

You may not qualify if:

• Any active implantable neuromodulation device or system (e.g., Peripheral Nerve Stimulation, Sacral Neuromodulation)
• 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
• 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
• Serious drug-related behavioral issues (e.g., alcohol dependency, illegal substance abuse), as determined by the Investigator or designee
• Pregnant or planning on becoming pregnant
• Involved in an injury claim under current litigation, beneficiary of an injury claim, or receiving worker's compensation
• Patients with buried lead trials/implants will be excluded from this study

Sponsors & Collaborators

• MedtronicNeuro: lead

Study Sites (10)

Coastal Research Institute

Carlsbad, California, 92009, United States

Location

Pain Management Consultants of Southwest Florida

Fort Myers, Florida, 33907, United States

Location

Twin Cities Pain Clinic

Edina, Minnesota, 55439, United States

Location

Garden State Pain and Orthopedics

Clifton, New Jersey, 07013, United States

Location

Novant Health Spine Specialists

Winston-Salem, North Carolina, 27103, United States

Location

Oklahoma Pain Management

Oklahoma City, Oklahoma, 73134, United States

Location

Pain Diagnostics and Interventional Care

Sewickley, Pennsylvania, 15143, United States

Location

North Texas Orthopedics and Spine Center

Grapevine, Texas, 76051, United States

Location

The San Antonio Orthopaedic Group

San Antonio, Texas, 78235, United States

Location

Procura Pain and Spine PLLC

Shenandoah, Texas, 77384, United States

Location

MeSH Terms

Conditions

Pain, Intractable; Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mirit Argov

  Medtronic

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: March 20, 2023
• Study Start: April 25, 2023
• Primary Completion: May 29, 2025
• Study Completion: May 29, 2025
• Last Updated: January 14, 2026

Record last verified: 2026-01

Locations

US (10)