Study to Evaluate Neuromodulation Subject Experience With... | NCT05775510

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why 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.

Expanded Access Info

Start Date

Apr 25, 2023Actual

Primary Completion Date

May 29, 2025Actual

Completion Date

May 29, 2025Actual

First Submitted Date

Feb 17, 2023

First Submission Date that Met QC Criteria

Mar 16, 2023

First Posted Date

Mar 20, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2026

Last Update Posted Date

Jan 14, 2026Actual

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Label	Type	Description	Intervention Names
Pilot Phase Cohort			Device: Commercially available neurostimulation systems
Data at Scale Phase Cohort			Device: Commercially available neurostimulation systems

Name	Type	Description	Arm Group Labels	Other Names
Commercially available neurostimulation systems	Device	Spinal cord stimulation therapy delivered during trialing and following implant of commercially available neurostimulation systems

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Coastal Research Institute		Carlsbad	California	92009	United States
Pain Management Consultants of Southwest Florida

ID	Term
D010148	Pain, Intractable
D059350	Chronic Pain

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms