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

Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05302063
Collaborator
(none)
40
1
39

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
  • Device: Spinal Cord Stimulation (SCS)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Clinical Outcomes and Pathology of Painful Diabetic Peripheral Neuropathy (pDPN)
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

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.
Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT05302063
Other Study ID Numbers:
  • A4105
First Posted:
Mar 31, 2022
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Boston Scientific Corporation
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022