Pain, IntractableSENSE SCSNCT05775510
Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain
An observational study of Pain, Intractable and Pain, Chronic, run by MedtronicNeuro at 10 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Intractable, Pain, Chronic
- What is being tested?
- Commercially available neurostimulation systems
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 10 sitesUnited States
- Study dates
- 25 Apr 2023to 29 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Pilot Phase Inclusion Criteria:
- 18 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
Pilot Phase Exclusion Criteria:
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Coastal Research Institute
Carlsbad, California, 92009
Garden State Pain and Orthopedics
Clifton, New Jersey, 07013
Twin Cities Pain Clinic
Edina, Minnesota, 55439
Pain Management Consultants of Southwest Florida
Fort Myers, Florida, 33907
North Texas Orthopedics and Spine Center
Grapevine, Texas, 76051
Oklahoma Pain Management
Oklahoma City, Oklahoma, 73134
The San Antonio Orthopaedic Group
San Antonio, Texas, 78235
Pain Diagnostics and Interventional Care
Sewickley, Pennsylvania, 15143
Procura Pain and Spine PLLC
Shenandoah, Texas, 77384
Novant Health Spine Specialists
Winston-Salem, North Carolina, 27103
About this study
Official title: 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.
- Conditions
- Pain, Intractable, Pain, Chronic
- Being tested
- Commercially available neurostimulation systems
- Medical subject headings
- Pain, Intractable, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercially available neurostimulation systemsDevice
Spinal cord stimulation therapy delivered during trialing and following implant of commercially available neurostimulation systems
| Study group | Role | What they receive |
|---|---|---|
| Pilot Phase Cohort | Not described Receives: Device: Commercially available neurostimulation systems | |
| Data at Scale Phase Cohort | Not described Receives: Device: Commercially available neurostimulation systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start25 Apr 2023
- Primary completion29 May 2025
- Study completion29 May 2025
Why it stopped: Medtronic refocused on the most impactful global evidence needs for SCS. The decision wasn't related to safety or quality. Pilot data was sufficient, but the study ended early and did not move into the Data at Scale phase.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, IntractableStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedtronicNeuro
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mirit Argov, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775510
- Sponsor's protocol ID
- MDT22020
- Acronym
- SENSE SCS
- Status last verified
- Jan 2026
- First submitted
- 17 Feb 2023
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate Neuromodulation Subject Experience With Contemporary Spinal Cord Stimulation (SCS) Modalities for Chronic Pain (SENSE SCS Clinical Study)
- ClinicalTrials.gov ID
- NCT05775510
- Acronym / sponsor ID
- SENSE SCS / MDT22020
- Conditions
- Pain, Intractable, Pain, Chronic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Medtronic refocused on the most impactful global evidence needs for SCS. The decision wasn't related to safety or quality. Pilot data was sufficient, but the study ended early and did not move into the Data at Scale phase.
- Enrolment
- 91 participants (actual)
- Lead sponsor
- MedtronicNeuroIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pilot Phase Cohort | – | Device: Commercially available neurostimulation systems |
| Data at Scale Phase Cohort | – | Device: Commercially available neurostimulation systems |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercially available neurostimulation systemsSpinal cord stimulation therapy delivered during trialing and following implant of commercially available neurostimulation systems | Device | Data at Scale Phase Cohort, Pilot Phase Cohort |
Primary outcome
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.
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)
Results and safety
The study was stopped early (reason given: Medtronic refocused on the most impactful global evidence needs for SCS. The decision wasn't related to safety or quality. Pilot data was sufficient, but the study ended early and did not move into the Data at Scale phase.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mirit Argov study director
Medtronic
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Intractable and Pain, Chronic, run by MedtronicNeuro at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Medtronic refocused on the most impactful global evidence needs for SCS. The decision wasn't related to safety or quality. Pilot data was sufficient, but the study ended early and did not move into the Data at Scale phase.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of surveys completed from Baseline through the SCS Trial Period in the Pilot Phase Cohort. (time frame: Up to 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.