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

• Sponsor: MedtronicNeuro (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05775510
• Collaborator: (none)
• Enrollment: 1,575
• Anticipated Duration (Months): 36

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Intractable; Pain, Chronic	Device: Commercially available neurostimulation systems

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1575 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain (SENSE SCS Clinical Study)
• Anticipated Study Start Date: Mar 1, 2023
• Anticipated Primary Completion Date: Jun 1, 2025
• Anticipated Study Completion Date: Mar 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 will download the InsightPro™ clinical trial app directly to their own smart phone, both iOS (11.0 or later) and Android (5.0 or later) versions are available.

5. Willing and able to provide signed and dated informed consent in English

6. Willing and able to comply with all study procedures

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 or beneficiary of an injury claim

7. Patients with buried lead trials/implants will be excluded from this study

Data at Scale 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. Model 97719 Inceptiv™ is the neurostimulator intended for implant, once commercially available

4. Average pain intensity of ≥ 5 as measured using the verbal NRS (0-10) or medical history. NOTE: The primary target area of treatment(s) should have a pain score ≥ 5

5. Able to differentiate between pain associated with the indication for SCS implant and other types of pain, as determined by the Investigator or designee

6. On stable (no change in dose, route, or frequency) prescribed pain medications associated with the indication for SCS implant, as determined by the investigator or designee, for at least 3 months prior to enrolling in the study

7. Willing and able to use a personal smart phone for study surveys. NOTE: All subjects participating in the study will download the InsightPro™ clinical trial app directly to their own smart phone, both iOS (11.0 or later) and Android (5.0 or later) versions are available.

8. Willing and able to provide signed and dated informed consent in English

9. Willing and able to comply with all study procedures

Data at Scale 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. Those prescribed > 100 morphine milligram equivalents (MME) per day of opioids

6. Predominant sacroiliac joint pain as the main cause of chronic low-back pain

7. Has mechanical spine instability as determined by the Investigator

8. Pregnant or planning on becoming pregnant

9. Involved in an injury claim under current litigation or beneficiary of an injury claim

10. Patients with buried lead trials/implants will be excluded from this study

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• MedtronicNeuro

Investigators

• Study Director: Charisma Kumar, Medtronic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MedtronicNeuro
• ClinicalTrials.gov Identifier: NCT05775510
• Other Study ID Numbers: MDT22020
• First Posted: Mar 20, 2023
• Last Update Posted: Mar 20, 2023
• Last Verified: Mar 1, 2023

• 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
• Additional relevant MeSH terms: Chronic Pain; Pain, Intractable

Study Results

No Results Posted as of Mar 20, 2023