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

April 9, 2024 updated by: Boston Scientific Corporation

A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Clinical Outcomes and Pathology of 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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 12 months follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Scientific Corporation

Investigators

  • Study Director: Natalie Bloom Lyons, Boston Scientific Neuromodulation Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2022

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A4105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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