Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation

Conditions

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

Eligibility Criteria

Sex

ALL

Age

19 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• Peripheral Transcutaneous Magnetic Stimulation from MagVenture — DEVICE
  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

Study Details

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.

Key Dates

Start date

Mar 24, 2025

Status verified

Sep 2025

Primary completion

Jan 25, 2028

Completion

Feb 25, 2028

Study Design

Enrollment

50 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Arms

• Experimental: Post-traumatic or post-surgical chronic pain
  Arm Description: 50 Participants with post-surgical or post-traumatic chronic pain below the neck will be administered peripheral transcutaneous magnetic stimulation at the site of pain for 13 minutes for 4 consecutive days. Participants will be male or female between the ages of 19 and 80 years.

Primary Outcome Measure

Pressure Pain Assessment [ Time Frame: 1. On Day 1 (Baseline) 2. On Day 4 (post therapy) ]

Central Contacts

• Associate Professor
  305-348-9634
  [email protected]

Locations (1)

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