Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05775510
Other study ID # MDT22020
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 30, 2023
Est. completion date March 2026

Study information

Verified date April 2024
Source MedtronicNeuro
Contact Study Inbox
Phone 763-514-4000
Email rs.sensescsstudy@medtronic.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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). 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1650
Est. completion date March 2026
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Coastal Research Institute Carlsbad California
United States Garden State Pain and Orthopedics Clifton New Jersey
United States Twin Cities Pain Clinic Edina Minnesota
United States Pain Management Consultants of Southwest Florida Fort Myers Florida
United States North Texas Orthopedics and Spine Center Grapevine Texas
United States Oklahoma Pain Management Oklahoma City Oklahoma
United States The San Antonio Orthopaedic Group San Antonio Texas
United States Procura Pain and Spine PLLC Shenandoah Texas
United States Novant Health Spine Specialists Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
MedtronicNeuro

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT05452499 - Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae N/A
Recruiting NCT05037682 - Pain and Opioid Management in Older Adults N/A
Completed NCT04080037 - Assessing Opioid Care Practices Using CPV Patient Simulation Modules N/A
Recruiting NCT05382962 - iCanCope With Post-Operative Pain (iCanCope PostOp) N/A
Recruiting NCT04285112 - SPRINT: Signature for Pain Recovery IN Teens
Active, not recruiting NCT04850079 - EHR Precision Drug Treatment in Neonates
Completed NCT03271151 - Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty Phase 4
Completed NCT03272139 - Interscalene Block Versus Superior Trunk Block Phase 4
Completed NCT03886142 - Platelet Rich Plasma Versus Radio Frequency for Chronic Knee Arthritis N/A
Recruiting NCT05761392 - APP-based Precise Management System of Chronic Intractable Pain N/A
Recruiting NCT05877157 - Pain AND Opioids After Surgery
Completed NCT03947749 - Linking Epigenomics With Prescription Opioid Abuse and High Impact Musculoskeletal Pain
Completed NCT03280017 - Ketamine With Multilevel Paravertebral Block for Post Video-assisted Thoracic Surgery Pain Phase 4
Recruiting NCT04874038 - Prevention of Persistent Pain With LidocAine iNfusions in Breast Cancer Surgery (PLAN) Phase 3
Completed NCT04280796 - Changes in Affective Pain Processing in Human Volunteers N/A
Withdrawn NCT05125978 - Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain Phase 2
Not yet recruiting NCT04328805 - Pain Reduction and Changes in Upper Limb Function Produced by an Ibuprofen Treatment in Carpal Tunnel Syndrome. Phase 4
Completed NCT04976738 - A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain Phase 1/Phase 2
Completed NCT04089618 - Meditation Based Lifestyle Modification in Chronic Pain N/A
Recruiting NCT05699837 - Alpha Entrainment for Pain and Sleep (Extension) N/A