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

Chronic Pain Clinical Trial

— 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302063
• Other study ID #: A4105
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2022
• Est. completion date: August 2026

Study information

• Verified date: June 2024
• Source: Boston Scientific Corporation
• Contact: Heleen Scholtes
• Phone: 855-213-9890
• Email: BSNClinicalTrials[@]bsci.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 2026
• Est. primary completion date: August 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Peripheral Nervous System Diseases

Intervention

Device:
• Spinal Cord Stimulation (SCS)
Boston Scientific Spinal Cord Stimulation Systems with multiple modalities

Locations

Country	Name	City	State
Spain	Hospital La Paz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 12 months follow up
Secondary	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.	Up to 12 months follow up