Retrospective-Prospective PNS Study

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: Chronic Pain
• Intervention / Treatment: Device: PNS device, observational study, no intervention during study

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Recruiting
      • The MetroHealth System
      • Contact: Samantha Pope; Phone Number: 216-778-1270; Email: Spope1@metrohealth.org
      • Contact: Brendan Astley, MD

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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	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	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	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	Average hours of sleep per night will be evaluated at baseline and all follow-up visits	12 months
Sleep disturbances	The amount of sleep disturbances (awakenings) per night to track quality of sleep	12 months
EQ-5D-5L	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	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

• Sponsor: Curonix LLC
• Collaborators: MetroHealth System, Ohio

Study record dates

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: chronic pain, PNS, Retrospective, prospective
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• 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