RecruitingNCT07507422

Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy

Post Market Evaluation of Real World Outcomes and Durability to Support Implantable SCS Therapy (PERSIST) Addendum - Inceptiv™ Spinal Cord Stimulation (SCS) Therapy

Sponsor

Medtronic

Enrollment

970 participants

Start Date

Apr 17, 2026

Study Type

OBSERVATIONAL

Conditions

Chronic Pain Intractable Pain

Summary

The PERSIST study is being conducted within Medtronic's active post-market surveillance platform, the Product Surveillance Registry (PSR). The purpose of PERSIST is to generate long-term evidence for the Inceptiv™ Spinal Cord Stimulation therapy.

Eligibility

Min Age: 18 Years

Inclusion Criteria17

18 years of age or older
Patient must be SCS therapy naïve
A clinical decision was made for the patient to receive an Inceptiv™ SCS system (pending satisfactory results from a Medtronic SCS trial) limited to on-label leads based on the specific geography for an on-label indication prior to enrollment in the study.
Patient is on stable opioid dosage for 3 months prior to enrollment, if applicable
Pain intensity of ≥ 6 as measured using the NPRS (0-10) in the predominant area(s) of pain that SCS is intended to treat
Patient must have an on-label indication specific to geography.
NOTE: Patients may be enrolled if they have upper limb radicular limb pain, related or unrelated to spine surgery
NOTE: In the US, patients experiencing chronic back pain without a history of spine surgery and not eligible for spine surgery are on-label candidates for SCS if the pain is associated with degenerative disc disease, herniated disc, or radicular pain syndrome. Radicular pain syndrome (with or without prior spine surgery) is an approved indication for SCS implant.
Diagnosis of chronic back and/or limb pain for an on-label indication lasting at least six months.
Clinical diagnosis of diabetes mellitus according to the American Diabetes Association guidelines (ADA).
Predominant pain condition being treated by SCS is lower-limb pain due to DPN
Hemoglobin A1c (HbA1c) must be <8% within 6 months of enrollment for inclusion or have completed a preoperative risk assessment if >8%
Presence of either numbness or at least one sensory disturbance (e.g., increased or decreased sensitivity, burning, pricking/stabbing, aching, "pins and needle" sensation) in the foot/feet.
Meets diagnostic criteria for CRPS (International Association for the Study of Pain "Budapest Criteria")
Disease that is clinically restricted to one hand or foot and affects the entire hand, foot or lower extremity
CRPS is the predominant pain condition that SCS is intended to treat
Be diagnosed with radicular pain syndrome, or be diagnosed with radicular pain secondary to failed back surgery or herniated disk

Exclusion Criteria30

Has any existing or is planning to have a new active implantable neuromodulation device or system during the 5 year follow up period (e.g., peripheral nerve stimulation, sacral neuromodulation, intrathecal drug delivery system, a second SCS system)
Has a complex pain pattern that involves both upper and lower limbs or back and upper limb
Has a planned major medical procedure within 6 months before enrollment or after implant that may interfere with study results or confound results as determined by the Investigator
Has a planned interventional procedure within 6 weeks (+/- 2 weeks) before enrollment or after implant that may interfere with study results or confound results as determined by the Investigator
Major untreated or unstable psychiatric comorbidity, such as suicidal ideations, personality disorders, schizophrenia etc., that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study, as determined by the Investigator
Subjects with PCS total score >30 are not eligible unless ALL of the following are met:
Absence of uncontrolled major psychiatric disorder or active suicidality based on clinical evaluation.
Investigator documentation of adequate understanding of therapy, realistic expectations, and anticipated compliance with protocol follow-up
Major non-indicated, untreated or refractory progressive disease (e.g., neurodegenerative disease {not including Diabetic Peripheral Neuropathy}, heart failure, cancer, osteoarthritis, fibromyalgia, chronic fatigue syndrome), or injury (e.g., fall resulting in hip fracture) that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study as determined by the Investigator
Has inpatient or outpatient admissions for drug or alcohol dependency within past 12 months or current/ongoing substance abuse
Has a current prescription of ≥90 morphine milligram equivalents (MME) per day
Has predominant mechanical back pain arising from facet or sacroiliac joint pain as the main cause of chronic low-back pain if low-back pain is the predominant pain condition, as determined by the Investigator
Has mechanical spine instability (eg. Spondylolisthesis grade 2) as determined by the Investigator
Has an active systemic or local infection that would delay trial or implant
Is pregnant or planning on becoming pregnant
Has a life expectancy of less than 1 year
Involved in an injury claim, under current litigation, beneficiary of an injury claim, receiving worker's compensation, or planning any future litigation
Has a condition that the Investigator determines would significantly increase perioperative risk (e.g., unstable or severe cardiac disease, liver disease, uncontrolled diabetes, kidney disease)
Lower-limb pain not associated with DPN or that cannot be distinguished from DPN (e.g., mononeuropathies, proximal neuropathies, nonneuropathic pain, peripheral vascular disease)
History of lower-limb amputation or planned lower-limb amputations due to diabetes
Large (≥3cm) and/or gangrenous ulcers or active infection of the lower limbs
Presence of Reynaud's disease
Current or previous neurologic abnormalities unrelated to CRPS
Another condition affecting the function of the diseased or contralateral extremity
Dystonia as a predominant component of their presentation
Has significant cervical stenosis, as determined by the Investigator
Failed treatments of carpal tunnel syndrome and/or cubital tunnel syndrome
Has mechanical neck pain (e.g., facet spondylosis), as determined by the Investigator
Any previous history of surgery on the posterior elements (laminectomy, posterior fusion) of the cervical spine
Has brachial plexus injury as predominant cause of pain