RECRUITING

Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation

Quick Facts

Study Start:2025-03-24
Study Completion:2028-02-25
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07199361

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.

Ages Eligible for Study:19 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of chronic peripheral pain secondary to trauma or surgery. Age 19 - 80; the lower end of this age range was chosen to capture young adults with pain, and participants over 80 years are increasingly likely to meet one or more exclusion criteria.
  1. * Implanted Electronic Devices and / or Conductive Objects in or near the head: Patients who have an implanted device that is activated or controlled in any way by physiological signals (examples: deep brain stimulators, cochlear implants, and vagus nerve stimulators).

Contacts and Locations

Study Contact

Associate Professor
CONTACT
305-348-9634
saaggarw@fiu.edu

Principal Investigator

Saurabh Aggarwal, MD., PhD
PRINCIPAL_INVESTIGATOR
Florida International University
Patricia Junquera, MD
PRINCIPAL_INVESTIGATOR
Florida International University and Baptist Health South Florida
Eduardo Icaza, MD
PRINCIPAL_INVESTIGATOR
Baptist Health South Florida

Study Locations (Sites)

Ambulatory Care Center, Florida International University
Miami, Florida, 33199
United States

Collaborators and Investigators

Sponsor: Florida International University

  • Saurabh Aggarwal, MD., PhD, PRINCIPAL_INVESTIGATOR, Florida International University
  • Patricia Junquera, MD, PRINCIPAL_INVESTIGATOR, Florida International University and Baptist Health South Florida
  • Eduardo Icaza, MD, PRINCIPAL_INVESTIGATOR, Baptist Health South Florida

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 Registration Dates

Study Start Date2025-03-24
Study Completion Date2028-02-25

Study Record Updates

Study Start Date2025-03-24
Study Completion Date2028-02-25

Terms related to this study

Keywords Provided by Researchers

  • Peripheral Transcutaneous Magnetic Stimulation
  • Post-Traumatic and Post-Surgical Chronic Pain

Additional Relevant MeSH Terms

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