TERMINATED

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

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Conditions

Pain, IntractablePain, Chronic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-04-25
Study Completion:2025-05-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05775510

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18 years of age or older
  2. 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. 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. 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. 5. Willing and able to provide signed and dated informed consent in English
  6. 6. Willing and able to comply with all study procedures and visits
  1. 1. Any active implantable neuromodulation device or system (e.g., Peripheral Nerve Stimulation, Sacral Neuromodulation)
  2. 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. 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. 4. Serious drug-related behavioral issues (e.g., alcohol dependency, illegal substance abuse), as determined by the Investigator or designee
  5. 5. Pregnant or planning on becoming pregnant
  6. 6. Involved in an injury claim under current litigation, beneficiary of an injury claim, or receiving worker's compensation
  7. 7. Patients with buried lead trials/implants will be excluded from this study

Contacts and Locations

Principal Investigator

Mirit Argov
STUDY_DIRECTOR
Medtronic

Study Locations (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

Collaborators and Investigators

Sponsor: MedtronicNeuro

  • Mirit Argov, STUDY_DIRECTOR, Medtronic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-25
Study Completion Date2025-05-29

Study Record Updates

Study Start Date2023-04-25
Study Completion Date2025-05-29

Terms related to this study

Additional Relevant MeSH Terms

  • Pain, Intractable
  • Pain, Chronic