Skip to main content
OpenTrials
Completed

NCT Number: NCT05302063

A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Painful Diabetic Peripheral Neuropathy (pDPN)

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital La Paz

Madrid, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Clinical diagnosis of diabetes mellitus, according to International Diabetes guidelines.
  • Willing and able to comply with all protocol-required procedures and assessments/evaluations.
  • Eligible candidate for SCS from a surgical, cognitive, psychological and psychiatric standpoint per site's routine screening process and based on investigator judgement.
  • Subject signed a valid, EC-approved informed consent form (ICF) provided in local language.

Key Exclusion Criteria:

  • Primary etiology for lower limb neuropathic pain not due to Diabetic Peripheral Neuropathy (DPN).
  • Participating (or intends to participate) in another drug or device clinical trial that may influence the data that will be collected for this study.
  • Currently implanted with an active implantable device(s) (e.g., pacemaker, drug pump).
  • A female who is pregnant, lactating, or is of childbearing potential and planning to get pregnant during the study or not using adequate contraception.

Treatment and study plan

Spinal cord stimulation (SCS)

Device

Boston Scientific Spinal Cord Stimulation Systems with multiple modalities

Primary outcomes

  1. Pain Relief in Limb Pain

    Time frame: 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 outcomes

  1. Global Impression of Change

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Boston Scientific Corporation

Industry

Registry information

Official study title

A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Clinical Outcomes and Pathology of Painful Diabetic Peripheral Neuropathy (pDPN)

Acronym: INSPIRE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 31, 2022
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.