INSPIRE: A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Painful Diabetic Peripheral Neuropathy (pDPN)
Study Details
Study Description
Brief Summary
The purpose of the study is to evaluate the effects of stimulation parameters on clinical outcomes of Spinal Cord Stimulation (SCS) in the treatment of chronic, intractable limb pain resulting from painful Diabetic Peripheral Neuropathy (pDPN).
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Spinal Cord Stimulation (SCS) Boston Scientific Spinal Cord Stimulation Systems with multiple modalities |
Device: Spinal Cord Stimulation (SCS)
Boston Scientific Spinal Cord Stimulation Systems with multiple modalities
|
Outcome Measures
Primary Outcome Measures
- Pain Relief in Limb Pain [Up to 12 months follow up]
Percent Pain Relief (PPR) in limb pain using a questionnaire where 100% is complete relief and 0% is no relief in pain compared with Baseline
Secondary Outcome Measures
- Global Impression of Change [Up to 12 months follow up]
Patient global impression of change (PGI-C) at 3-, 6- and 12-Month Assessment Visit where patients use a seven-point scale to assess how much their condition has improved or worsened relative to their baseline. Subjects will rate themselves as: very much improved; much improved; minimally improved; no change; minimally worse; much worse; or very much worse.
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Clinical diagnosis of diabetes mellitus, according to International Diabetes guidelines.
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Willing and able to comply with all protocol-required procedures and assessments/evaluations.
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Eligible candidate for SCS from a surgical, cognitive, psychological and psychiatric standpoint per site's routine screening process and based on investigator judgement.
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Subject signed a valid, EC-approved informed consent form (ICF) provided in local language.
Key Exclusion Criteria:
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Primary etiology for lower limb neuropathic pain not due to Diabetic Peripheral Neuropathy (DPN).
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Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
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Currently implanted with an active implantable device(s) (e.g., pacemaker, drug pump).
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A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Study Director: Roshini Jain, Boston Scientific Neuromodulation Corporation
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- A4105