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

Primary Purpose

Chronic Pain

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Spinal Cord Stimulation (SCS)
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Spinal Cord Stimulation, Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital La PazRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spinal Cord Stimulation (SCS)

Arm Description

Boston Scientific Spinal Cord Stimulation Systems with multiple modalities

Outcomes

Primary Outcome Measures

Pain Relief in Limb Pain
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
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.

Full Information

First Posted
March 21, 2022
Last Updated
October 3, 2023
Sponsor
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05302063
Brief Title
A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Painful Diabetic Peripheral Neuropathy (pDPN)
Acronym
INSPIRE
Official Title
A Study to Evaluate the Effect of Spinal Cord Stimulation (SCS) on Clinical Outcomes and Pathology of Painful Diabetic Peripheral Neuropathy (pDPN)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

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
Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Spinal Cord Stimulation, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Stimulation (SCS)
Arm Type
Experimental
Arm Description
Boston Scientific Spinal Cord Stimulation Systems with multiple modalities
Intervention Type
Device
Intervention Name(s)
Spinal Cord Stimulation (SCS)
Intervention Description
Boston Scientific Spinal Cord Stimulation Systems with multiple modalities
Primary Outcome Measure Information:
Title
Pain Relief in Limb Pain
Description
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
Time Frame
Up to 12 months follow up
Secondary Outcome Measure Information:
Title
Global Impression of Change
Description
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.
Time Frame
Up to 12 months follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heleen Scholtes
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
First Name & Middle Initial & Last Name or Official Title & Degree
Diane Keesey
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Bloom Lyons
Organizational Affiliation
Boston Scientific Neuromodulation Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Hospital La Paz
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boston Scientific Clinical Research
Phone
855-213-9890
Email
BSNClinicalTrials@bsci.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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