A Study of Spinal Cord Stimulation Programming Parameters
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-004164
NCT ID: NCT02503787
Sponsor Protocol Number: 1675
About this study
The purpose of this study is to evaluate programming options in spinal cord stimulation for the management of chronic, intractable pain of the trunk and limbs.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- Candidate for Spinal Cord Stimulation (SCS) system (trial and implant) per labeled indication(back and leg pain)
- Willing and able to provide a signed and dated informed consent
- At least 18 years old at the time of informed consent
- Willing and able to attend visits and comply with the study protocol
- Capable of using the patient programmer and recharging the neurostimulator
- Willing to not increase pain medications from baseline through the 3-month visit
Exclusion Criteria
- Currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound study results
- Psychological or other health conditions that would interfere with the subject's ability to fulfill the requirements of the protocol
- Trialed or implanted with SCS, subcutaneous stimulation, peripheral nerve stimulation or an implantable intrathecal drug delivery system
- Implanted with a cardiac device (e.g., pacemaker, defibrillator)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Tim Lamer, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available