Chronic PainPERSISTNCT07507422
Post Market Evaluation of Real World Outcomes and Durability to Support Implantable Inceptiv™ Spinal Cord Stimulation Therapy
An observational study of Chronic Pain and Intractable Pain, run by Medtronic at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Intractable Pain
- What is being tested?
- Commercially available Inceptiv™ neurostimulation systems
- Type of treatment
- Medical device
- How many people
- 970 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 17 Apr 2026to 11 Jan 2034
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The intended study population is adults with chronic, intractable pain of the trunk and/or limbs indicated for a Medtronic Inceptiv™ implantable neurostimulation system. Study eligibility criteria must be met to participate in this study.
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
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- 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)
- Patients enrolled into the study with Diabetic Peripheral Neuropathy, Complex Regional Pain Syndrome and Upper Limb pain are required to meet further inclusion/exclusion criteria in order to contribute to the analysis for that particular condition. These criteria are designed to ensure that the patient's condition aligns with the standard diagnostic criteria set by applicable clinical guidelines.
- Painful Diabetic Peripheral Neuropathy (DPN) Inclusion Criteria
- 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.
- Painful DPN Exclusion Criteria
- 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
- Complex Regional Pain Syndrome (CRPS) Inclusion Criteria
- 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
- CRPS Exclusion Criteria
- 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
- Upper Limb Pain (ULP) - non CRPS Inclusion Criteria
- Be diagnosed with radicular pain syndrome, or be diagnosed with radicular pain secondary to failed back surgery or herniated disk
- ULP - non CRPS Exclusion Criteria
- 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
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
North Texas Orthopedics and Spine Center
Houston, Texas, 76051-3930
Katelynn Traver
Melissa Murphy
- Recruiting
Center for Pain and Supportive Care
Phoenix, Arizona, 85028
Krisstin Hammond
Gobi Paramanandam
- Recruiting
Christus Surgery Center- Westover Hills, LLC
San Antonio, Texas, 78251
Rosa Gonzalez, 512-421-3851, rosa.gonzalez@christushealth.org
George Galvan
- Recruiting
Relieve Pain Center
San Diego, California, 92110
Chelsea Harkness, 509-528-9591, charkness@relievepaincenter.com
Chelsea Harkness, charkness@relievepaincenter.com
- Recruiting
Christian Hospital
St Louis, Missouri, 63136-6119
Maksim Shoykhet
Christopher Beuer
France1 site, 1 recruiting
- Recruiting
Hôpital Claude Huriez
Lille, Cedex, 59037
Lauri Parmentier, +33-03-20-44-59-62, laurie.parmentier@chu-lille.fr
Gilles Lebuffe
About this study
Official title: Post Market Evaluation of Real World Outcomes and Durability to Support Implantable SCS Therapy (PERSIST) Addendum - Inceptiv™ Spinal Cord Stimulation (SCS) Therapy
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.
- Conditions
- Chronic Pain, Intractable Pain
- Being tested
- Commercially available Inceptiv™ neurostimulation systems
- Medical subject headings
- Chronic Pain, Pain, Intractable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commercially available Inceptiv™ neurostimulation systemsDevice
Spinal cord stimulation therapy delivered during trialing and following implant of commercially available Inceptiv™ neurostimulation systems
| Study group | Role | What they receive |
|---|---|---|
| PERSIST Cohort | Not described Receives: Device: Commercially available Inceptiv™ neurostimulation systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of implanted patients who have a ≥ 50% improvement in pain score as assessed by numeric pain rating scale (NPRS) from baseline for the predominant pain being treated at 6 months following device activation
This outcome measures the percentage of implanted patients who demonstrate improvement in pain for the predominant pain condition being treated at 6 months following device activation, compared to baseline. Pain is assessed using the NPRS (with 0=no pain and 10=highest level of pain).
Measured: Baseline and 6 months after device activation
Percentage of implanted patients who are a composite responder at 6 months following device activation
A composite responder is defined as an implanted patient who demonstrates an improvement from baseline in at least one of the following measures at the specified follow-up time: pain, quality of life, or pain-related disability.
Pain is assessed using the Numeric Pain Rating Scale (NPRS 0=no pain and 10=worst possible pain), with improvement defined as a reduction in pain score from baseline. Quality of life is assessed using the EQ-5D-5L index value, with improvement defined as positive change from baseline. Pain-related disability is assessed using the Pain Disability Index (PDI), with improvement defined as negative change from baseline.
Measured: Baseline and 6 months after device activation
Secondary outcomes (1)
Percentage of implanted patients who are a composite responder
A composite responder is defined as an implanted patient who demonstrates an improvement from baseline in at least one of the following measures at the specified follow-up time: pain, quality of life, or pain-related disability. Pain is assessed using the Numeric Pain Rating Scale (NPRS 0=no pain and 10=worst possible pain), with improvement defined as a reduction in pain score from baseline. Quality of life is assessed using the EQ-5D-5L index value, with improvement defined as positive change from baseline. Pain-related disability is assessed using the Pain Disability Index (PDI), with improvement defined as negative change from baseline.
Measured: Baseline and 3 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months after device activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start17 Apr 2026
- Primary completion27 Jun 2029 (estimated)
- Study completion11 Jan 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by MedtronicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 970 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medtronic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Holly Norman, PhD, MBA, Study director, Medtronic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507422
- Sponsor's protocol ID
- PSR-PSTM PERSIST
- Acronym
- PERSIST
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No