Actively Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Led by Florida International University · Updated on 2025-09-30
50
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
F
Florida International University
Lead Sponsor
B
Baptist Health South Florida
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of chronic peripheral pain caused by trauma or surgery
- Age between 19 and 80 years
- Currently receiving pain medication
- Chronic peripheral pain occurring more than once per week for at least three consecutive months
- Stable on pain medications for at least 60 days prior to participation
You will not qualify if you...
- Presence of implanted electronic devices or conductive objects near the head (e.g., deep brain stimulators, cochlear implants, vagus nerve stimulators)
- Non-removable metallic objects within 30 cm of the treatment coil (e.g., aneurysm clips, stents, bullet fragments)
- Active microbial infections
- Positive urine drug test for non-pain medications (excluding stable methadone or buprenorphine for opioid addiction treatment)
- Systemic rheumatic diseases such as rheumatoid arthritis or lupus
- Severe frailty or wasting syndrome as determined by Groningen Frailty Index score greater than 4
- Uncontrolled hypertension or cardiovascular/peripheral arterial disease
- Poorly controlled diabetes (HbA1c greater than 8%)
- Neurological diseases like Parkinson's or multiple sclerosis
- Serious psychiatric disorders requiring hospitalization in the past 12 months or active suicidal thoughts
- Cognitive impairment with MMSE score less than 18
- Pregnancy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ambulatory Care Center, Florida International University
Miami, Florida, United States, 33199
Actively Recruiting
Research Team
A
Associate Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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