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Observational Study of Inceptiv™ Spinal Cord Stimulation for Chronic Pain

This study is looking at how well the Inceptiv™ Spinal Cord Stimulation (SCS) system works in real-world settings for people with chronic pain. SCS is a therapy that uses a small device to send electrical pulses to the spinal cord to help manage pain. The study will follow nearly 1000 patients who are receiving this treatment for the first time. Researchers want to see what percentage of patients experience a 50% or more improvement in their pain score and how many are considered "composite responders" (meaning they meet several success criteria) six months after their device is activated. You may be able to join if you are 18 or older, have not had SCS therapy before, and your doctor has decided the Inceptiv™ SCS system is right for you.

Study design
This is an observational study, meaning researchers will collect information on patients who are already receiving the Inceptiv™ Spinal Cord Stimulation therapy. It plans to include about 970 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least six months after their device is activated to assess pain improvement.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07507422

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

Recruiting
Not specifiedAges 18+Observational
Medtronic
~970 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Commercially available Inceptiv™ neurostimulation systems

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Baseline and 6 months after device activation
+1 more outcome measured

Conditions

Chronic Pain
Intractable Pain

Explore related trials

Chronic PainIntractable Pain

Where it's being run

3 sites across 3 states
Arizona1
Missouri1
Texas1

Study leadership

  • Holly Norman, PhD, MBA · STUDY_DIRECTOR · Medtronic

Who to contact

Study Inbox
[email protected]
1-800-633-8766
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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. 7. 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

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

What this trial measures

  • 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 activationBaseline and 6 months after 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).

  • Percentage of implanted patients who are a composite responder at 6 months following device activationBaseline and 6 months after 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.