Recruiting

pTMS

Sponsor:

Florida International University

Code:

NCT07199361

Conditions

Post-Surgical Pain, Chronic

Post-traumatic Pain, Chronic

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Peripheral Transcutaneous Magnetic Stimulation from MagVenture

Study Details

Brief 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

Study ID

NCT07199361

Start date

Mar 24, 2025

Status verified date

Sep, 2025

Completion date

Feb 25, 2028

Anticipated

Primary completion date

Jan 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Currently receiving pain medication Chronic pain must self-report peripheral pain, more than once per week, for at least three consecutive months

Exclusion Criteria:

  • 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).

Non-Removable Metallic Objects near the coil: Patients who have conductive, ferromagnetic, or other magnetic-sensitive metals implanted in their head or within 30 cm of the treatment coil (examples: cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, and bullet fragments). F NOTE: Standard amalgam dental fillings are not affected by the magnetic field and are acceptable in patients.

Active microbial infections may alter the quantity or quality of blood inflammatory cells such as monocytes and neutrophils.

Positive Urine Drug test: (COC/AMP/OPI/mAMP/PCP/BAR/BZO/MTD/MDMA/OXY/PPX/BUP/TCA) Use of any medication other than pain medications. However, participants will not be excluded or asked to withdraw from medications used for pain management since temporary withdrawal from these medications could affect pain measures (exceptions will be therapies such as methadone or buprenorphine used to treat opioid addiction). Only those who have been stable on these medications for at least 60 days will be included. All patient medications used for at least 60 days prior to participation will be recorded and controlled in statistical analyses as needed.

Systemic rheumatic disease (e.g., rheumatoid arthritis, systemic lupus erythematosus). These rheumatologic conditions will be excluded due to their autoimmune characteristic.

Cachexia (wasting syndrome) and severe frailty as determined by the Groningen Frailty Index (score >4). This exclusion is in place to protect against the stress of experimental pain testing.

Uncontrolled hypertension (i.e. SBP/DBP of >140/90) or cardiovascular or peripheral arterial disease. These exclusions are in place primarily for safety reasons because the cold pressor task represents a cardiovascular challenge. However, uncontrolled hypertension can also affect pain perception, which is another reason for excluding these individuals.

Poorly controlled diabetes (HbA1c > 8%) for both safety reasons and because diabetic neuropathy could alter pain perception.

Neurological disease (e.g. Parkinson's, multiple sclerosis). Serious psychiatric disorder requiring hospitalization within the past 12 months or characterized by active suicidal ideation. Any participant deemed to be actively suicidal upon study screening will be escorted to the emergency room and evaluated by the Psychiatry Service.

A diminished cognitive function that would interfere with the understanding of study procedures. The Mini-Mental Status Exam (MMSE) will be administered to ensure that participants are free of cognitive impairment that would compromise study participation. MMSE <18 will be excluded.

Pregnancy

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

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

Primary outcome measure

  • Pressure Pain Assessment [ Time Frame: 1. On Day 1 (Baseline) 2. On Day 4 (post therapy) ]
  • Thermal (Heat) pain [ Time Frame: 1. On day 1 (Baseline) 2. On day 4 (Post therapy) ]
  • Thermal (Cold) Pain [ Time Frame: 1. On day 1 (Baseline) 2. On day 4 (Post therapy) ]
  • Temporal Heat Summation [ Time Frame: 1. On day 1 (Baseline) 2. On Day 4 (Post therapy) ]
  • Conditioned Pain Modulation [ Time Frame: 1. On day 1 (Baseline) 2. On day 4 (Post Therapy) ]

Central Contacts and Locations

Central contacts

Locations

Ambulatory Care Center, Florida International University

Recruiting

Miami, Florida, United States, 33199

Contacts

More Information

Sponsor

Florida International University

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Florida International University on 2025-09-30.