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

Active, not recruiting

• Conditions: Pain, Chronic; Pain, Intractable
• Interventions: Device: Commercially available neurostimulation systems

• Registration Number: NCT05775510
• Lead Sponsor: MedtronicNeuro

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-03-16
• Study First Posted: 2023-03-20
• Study Start: 2023-03-30
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-01
• Last Update Posted: 2025-05-04
• Primary Completion: 2025-06
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1650

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pilot Phase Cohort	Commercially available neurostimulation systems	-
Data at Scale Phase Cohort	Commercially available neurostimulation systems	-

Primary Outcome Measures

Name	Time	Method
Percentage of surveys completed from Baseline through the SCS Trial Period in the Pilot Phase Cohort.	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.
Rating on the 7-point scale of Patient Global Impression of Change (PGIC) at Month 3 in the Data at Scale Phase Cohort	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)

Trial Locations

Locations (10)

Coastal Research Institute; 🇺🇸 Carlsbad, California, United States

Pain Management Consultants of Southwest Florida; 🇺🇸 Fort Myers, Florida, United States

Twin Cities Pain Clinic; 🇺🇸 Edina, Minnesota, United States

Garden State Pain and Orthopedics; 🇺🇸 Clifton, New Jersey, United States

Novant Health Spine Specialists; 🇺🇸 Winston-Salem, North Carolina, United States

Oklahoma Pain Management; 🇺🇸 Oklahoma City, Oklahoma, United States

Pain Diagnostics and Interventional Care; 🇺🇸 Sewickley, Pennsylvania, United States

North Texas Orthopedics and Spine Center; 🇺🇸 Grapevine, Texas, United States

The San Antonio Orthopaedic Group; 🇺🇸 San Antonio, Texas, United States

Procura Pain and Spine PLLC; 🇺🇸 Shenandoah, Texas, United States