Status:
RECRUITING
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Lead Sponsor:
Florida International University
Collaborating Sponsors:
Baptist Health South Florida
Conditions:
Post-Surgical Pain, Chronic
Post-traumatic Pain, Chronic
Eligibility:
All Genders
19-80 years
Phase:
NA
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-surgic...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 25 2028
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07199361
Start Date
March 24 2025
End Date
February 25 2028
Last Update
September 30 2025
Active Locations (1)
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1
Ambulatory Care Center, Florida International University
Miami, Florida, United States, 33199