ClinicalTrials.gg
TerminatedNCT05775510SENSE SCSUpdated Jan 14, 2026

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

An observational study in Pain, Intractable and Pain, Chronic, sponsored by MedtronicNeuro. Terminated at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.

Sponsored by MedtronicNeuro (part of Medtronic) · Observational

Why this study was terminated
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.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
91
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Pain, Intractable
  • Pain, Chronic
03

In context

Pain, Intractable

90 studies on the registry are indexed under Pain, Intractable; 16 are open to participants now.

This study's enrollment of 91 is close to the median of 91 across 19 observational studies indexed under Pain, Intractable.

Browse Pain, Intractable studies →

Lead sponsor

MedtronicNeuro is the lead sponsor of 74 studies on the registry; 2 are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 17 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Eligibility criteria

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 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 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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
91 participants (actual)
Patient registry
No

Groups and cohorts

  • Pilot Phase Cohort

    Device: Commercially available neurostimulation systems

  • Data at Scale Phase Cohort

    Device: Commercially available neurostimulation systems

Interventions

  • DeviceCommercially available neurostimulation systems

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 28 days

  2. 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)

    Time frame: Month 3

07

Study locations

10 sites
  • Coastal Research Institute
    Carlsbad, California 92009, United States
  • Pain Management Consultants of Southwest Florida
    Fort Myers, Florida 33907, United States
  • Twin Cities Pain Clinic
    Edina, Minnesota 55439, United States
  • Garden State Pain and Orthopedics
    Clifton, New Jersey 07013, United States
  • Novant Health Spine Specialists
    Winston-Salem, North Carolina 27103, United States
  • Oklahoma Pain Management
    Oklahoma City, Oklahoma 73134, United States
  • Pain Diagnostics and Interventional Care
    Sewickley, Pennsylvania 15143, United States
  • North Texas Orthopedics and Spine Center
    Grapevine, Texas 76051, United States
  • The San Antonio Orthopaedic Group
    San Antonio, Texas 78235, United States
  • Procura Pain and Spine PLLC
    Shenandoah, Texas 77384, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2023 to primary completion in May 2025, 25 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 17, 2023
First posted
Mar 20, 2023
StartActual
Apr 25, 2023
Primary completionActual
May 29, 2025
CompletionActual
May 29, 2025
Last update
Jan 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05775510
Lead sponsor
MedtronicNeuro
Responsible party
Sponsor
First posted
Mar 20, 2023
Start date
Apr 25, 2023
Primary completion
May 29, 2025
Completion
May 29, 2025
Last update
Jan 14, 2026

Study contacts

Mirit Argov
study director · Medtronic

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

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