Retrospective-Prospective PNS Study

February 24, 2025 updated by: Curonix LLC

Retrospective-Prospective Clinical Trial Investigating the Treatment of Chronic Pain with the Freedom Peripheral Nerve Stimulation System

This is a retrospective-prospective study in which 40 patients have received a permanent Freedom PNS System. Subjects presented with chronic, intractable pain of peripheral nerve origin refractory to standard medical and/or surgical treatment.

A retrospective chart review will be conducted to assess baseline and follow-up parameters in patients who have received a permanent implant with the Freedom PNS system for at least 12 months. Missing data might be collected after informed consent.

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 Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Recruiting
        • The MetroHealth System
        • Contact:
        • Contact:
          • Brendan Astley, MD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

A. Subject is ≥ 18 years of age at time permanent implant; B. Subject has been implanted with the Freedom PNS system; C. Subject is willing to attend visit as scheduled, and comply with the study requirements (if prospective); D. Patient is capable of giving informed consent.

Exclusion Criteria:

A. Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study (if prospective); B. Any additional active implanted devices for the treatment of chronic pain in addition to the Freedom PNS system.

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Observational
observational
Device: PNS device, observational study, no intervention during study
PNS device, observational study, no intervention during study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain scores
Time Frame: 12 months
A text description of the subject's pain location(s) and severity will be recorded to correlate with subject feedback. The VRS will be used to measure severity.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioids
Time Frame: 12 months
Each subject's opioid medication type, dose, frequency, and method of administration will be recorded at baseline and follow-up visit.
12 months
Work status
Time Frame: 12 months
Work history and status will be evaluated based on a subject's self-reported questionnaire(s) completed at screening/baseline and all follow up visits.
12 months
GPES
Time Frame: 12 months
Subject satisfaction with the implant will be measured by assessing global perceived effects (GPES) on a 7-point scale (1 = worst and 7 = best)
12 months
Amount of sleep
Time Frame: 12 months
Average hours of sleep per night will be evaluated at baseline and all follow-up visits
12 months
Sleep disturbances
Time Frame: 12 months
The amount of sleep disturbances (awakenings) per night to track quality of sleep
12 months
EQ-5D-5L
Time Frame: 12 months
The European Quality of Life - 5 Dimension - 5L (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome.
12 months
Claims data
Time Frame: 12 months
The value of claims data at the site will be measured from 1 year before and up to the date of implant and compared to the claims value up to 1 year after implant. The number of appointments will be collected together with the CPT codes used for pain interventions.
12 months

Collaborators and Investigators

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

Sponsor

Curonix LLC

Collaborators

MetroHealth System, Ohio

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)

July 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 24, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

No

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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