Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-29 @ 5:45 PM
Study NCT ID:
NCT07199361
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2025-09-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Sponsor:
Florida International University
Organization:
Study Overview
Official Title:
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
Chronic pain (pain lasting ≥3 months) is a debilitating condition associated with depression, dementia, increased risk of suicide, decreased productivity, and substance abuse. Opioids continue to be a crucial part of pain management. However, the misuse of prescription opioids has led to a shift towards injectable opioids such as heroin, with nearly 80% of new heroin users reporting prior use of prescription opioids. Further, co-morbid substance abuse can exacerbate pain symptoms despite pharmaceutical treatment, revealing the limitations of current pain management strategies. Due to tolerance, people with a history of opioid dependence often need higher doses of opioids to treat acute pain and long-term opioid use paradoxically worsens chronic pain. From a public health perspective, there is an increased chance of transmitting and acquiring hepatitis B and C due to opioid use-related engagement in risky behaviors. Moreover, the economic burden of untreated pain in the US is estimated to be more than $100 billion per year. Therefore, there is an urgent need to develop novel therapeutic strategies and reduce reliance on opioids.
Peripheral Transcutaneous Magnetic Stimulation (pTMS) is a non-invasive method of relieving pain by stimulating the target area with magnetic pulses. The magnetic field pulse passing into the body induces a voltage difference between any two points, which creates an electric field and causes electrons to flow between these two points. The magnetic field can penetrate deep tissue, such as spinal nerve roots or muscles. No mechanical contact is necessary, making pTMS applicable to patients with extreme hypersensitivity or allodynia to skin touch. pTMS is FDA-cleared for post-traumatic and post-surgical chronic pain. However, to date, no clear evidence has emerged about pTMS's potential mechanism of pain relief, which has moderated its applicability and acceptability.
The study will require recruiting patients over the phone, followed by an on-site visit, which includes patient interaction, blood collection, pain study, performing pTMS therapy at the site of pain, and patient monitoring. Three more on-site visits on consecutive days will include pTMS therapy. The last (fourth) visit will include specimen collection and a pain study. The first and the fourth visits will take 2.5 hours, while the second and the third visits will require 30 minutes. The participants will be followed over the phone every 30 days till the completion of the study to inquire about their wellness.
Peripheral Transcutaneous Magnetic Stimulation (pTMS) is a non-invasive method of relieving pain by stimulating the target area with magnetic pulses. The magnetic field pulse passing into the body induces a voltage difference between any two points, which creates an electric field and causes electrons to flow between these two points. The magnetic field can penetrate deep tissue, such as spinal nerve roots or muscles. No mechanical contact is necessary, making pTMS applicable to patients with extreme hypersensitivity or allodynia to skin touch. pTMS is FDA-cleared for post-traumatic and post-surgical chronic pain. However, to date, no clear evidence has emerged about pTMS's potential mechanism of pain relief, which has moderated its applicability and acceptability.
The study will require recruiting patients over the phone, followed by an on-site visit, which includes patient interaction, blood collection, pain study, performing pTMS therapy at the site of pain, and patient monitoring. Three more on-site visits on consecutive days will include pTMS therapy. The last (fourth) visit will include specimen collection and a pain study. The first and the fourth visits will take 2.5 hours, while the second and the third visits will require 30 minutes. The participants will be followed over the phone every 30 days till the completion of the study to inquire about their wellness.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: