Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 Inceptivâ„¢ Spinal Cord Stimulation therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PERSIST Cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Commercially available Inceptivâ„¢ neurostimulation systems | Device | Spinal cord stimulation therapy delivered during trialing and following implant of commercially available Inceptivâ„¢ neurostimulation systems |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | Baseline and 6 months after device activation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
18 years of age or older
Patient must be SCS therapy naïve
A clinical decision was made for the patient to receive an Inceptivâ„¢ 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.
Diagnosis of chronic back and/or limb pain for an on-label indication lasting at least six months.
Exclusion Criteria:
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:
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
Painful DPN Exclusion Criteria
Complex Regional Pain Syndrome (CRPS) Inclusion Criteria
CRPS Exclusion Criteria
Upper Limb Pain (ULP) - non CRPS Inclusion Criteria
ULP - non CRPS Exclusion Criteria
Not provided
Not provided
Not provided
The intended study population is adults with chronic, intractable pain of the trunk and/or limbs indicated for a Medtronic Inceptivâ„¢ implantable neurostimulation system. Study eligibility criteria must be met to participate in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Inbox | Contact | 1-800-633-8766 | rs.persiststudy@medtronic.com |
| Name | Affiliation | Role |
|---|---|---|
| Holly Norman, PhD, MBA | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Pain and Supportive Care | Recruiting | Phoenix | Arizona | 85028 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Christian Hospital | Recruiting | St Louis | Missouri | 63136-6119 | United States |
|
| North Texas Orthopedics and Spine Center | Recruiting | Houston | Texas | 76051-3930 | United States |
|
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| D010148 | Pain, Intractable |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided