Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation

Summary

This research aims to uncover the Mechanisms of pain relief through the FDA-cleared peripheral transcutaneous magnetic stimulation (pTMS) device by MagVenture. 50 people with chronic pain (post-surgical or post-traumatic) will be identified and recruited. The eligibility for participation in the study will be evaluated by a series of pain and mental health questionnaires followed by quantitative sensory testing (QST) to assess response to noxious heat, cold, and pressure stimuli. Blood will be drawn to isolate plasma, serum, and leukocytes. Participants will then undergo pTMS at the site of pain for four consecutive days. At the end of the therapy, pain testing will be done again, followed by blood withdrawal to assess the changes in plasma and leukocyte levels of mediators of pain. It is anticipated that pTMS will increase mediators of pain relief and reduce inflammatory mediators. Risks: It is possible that a few participants may not respond to pTMS therapy. However, plasma analysis of mediators of pain may help stratify these participants into responders vs. non-responders. Risks associated with the study are minimal and mainly involve discomfort associated with pain testing. The importance of knowledge gained includes understanding pain relief mechanisms by medical devices such as pTMS, which will result in better pain management.

Conditions

• Post-Surgical Pain, Chronic
• Post-traumatic Pain, Chronic

Interventions

DEVICE

Peripheral Transcutaneous Magnetic Stimulation from MagVenture

MagVenture Pain Therapy System: It is an FDA-cleared magnetic stimulator system that provides brief and focused magnetic pulses to non-invasively stimulate peripheral nerves and provide relief of chronic intractable, post-traumatic, and post-surgical pain for patients 18 years or older. It is a relatively new technique in the US for pain relief in the clinical setting and thus not very widespread yet. Evidence shows Magnetic Peripheral Nerve Stimulation to have a promising average pain relief of up to 87%\*. Using magnetic pulses, MagVenture Pain Therapy engages sensory, pain, and motor fibers mechanistically to recondition the central nervous system by eliminating noxious pain signals to the brain, reducing chronic neuropathic pain for responsive patients. \*Bedder M, Parker L.: Magnetic Peripheral Nerve Stimulation (mPNS) for Chronic Pain, 2023

Sponsors & Collaborators

• Baptist Health South Florida

  collaborator OTHER

• Florida International University

  lead OTHER

Principal Investigators

• Saurabh Aggarwal, MD., PhD · Florida International University

• Patricia Junquera, MD · Florida International University and Baptist Health South Florida

• Eduardo Icaza, MD · Baptist Health South Florida

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

19 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-03-24

Primary Completion

2028-01-25

Completion

2028-02-25

FDA Device

Yes

Countries

• United States

Study Locations