NCT07199361 Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
| NCT ID | NCT07199361 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Florida International University |
| Condition | Post-Surgical Pain, Chronic |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-03-24 |
| Primary Completion | 2028-01-25 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-03-24 with a primary completion date of 2028-01-25.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Saurabh Aggarwal, MD., PhD
PRINCIPAL INVESTIGATOR
Florida International University
Frequently Asked Questions
Who can join the NCT07199361 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 80 Years, studying Post-Surgical Pain, Chronic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07199361 currently recruiting?
Yes, NCT07199361 is actively recruiting participants. Contact the research team at saaggarw@fiu.edu for enrollment information.
Where is the NCT07199361 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07199361 clinical trial?
NCT07199361 is sponsored by Florida International University. The principal investigator is Saurabh Aggarwal, MD., PhD at Florida International University. The trial plans to enroll 50 participants.