Neuropathic Pain in Pregnancy

This is an interventional supportive care trial for Pain focused on measuring neuropathic pain, pregnancy Read More

Part A

Inclusion Criteria:

• age 18-45 years old,
• ability to give informed consent,
• viable pregnancy, and
• enrollment prior or equal to 24 weeks gestation

Exclusion Criteria:

• Active or history of substance use disorder within the past year
• Non-English speaking

Part B

Inclusion Criteria:

• Subjects enrolled in Part A and willing to consent to Part B of this protocol
• Pregnant with current chronic neuropathic pain

• Subjects failed treatment with amitriptyline or nortriptyline as defined by one of the following:

  • no clinical improvement following a 4-week trial of amitriptyline or nortriptyline (i.e., CGI-I score ≥4)
  • an inability to tolerate the medication (i.e., side effects)
• Subjects must pass the TMS Safety Checklist Adult Safety Screen (TASS).
• Subjects should be off medication, which can lower seizure thresholds (e.g., amitriptyline and nortriptyline) for at least two weeks prior to study entry.
• Subjects with neuropathic pain including those with diagnosis of spinal cord injury, fibromyalgia, compression neuropathies (including diabetic peripheral neuropathy), post stroke pain, and multiple sclerosis
• Subjects with a baseline VAS score greater than 30

Exclusion Criteria:

• Current or past history of a seizure disorder (e.g., epilepsy)
• Current history of preeclampsia
• Current or history of brain lesions (e.g., aneurysm)
• History of major head trauma (e.g., stroke; previous cranial neurosurgery)
• Ferromagnetic metal in the head, neck, or chest (e.g., plates or pins, bullets, shrapnel)
• Microprocessor implants in the head (e.g., cochlear implants) or life-sustaining microprocessor implants anywhere in the body (e.g., prosthetic cardiac valves)
• Cardiac pacemaker
• Active or inactive implants (e.g., deep brain stimulators, vagus nerve stimulators)
• Active treatment with medications that lower seizure threshold (e.g., bupropion, amitriptyline, nortriptyline, or other TCA)
• Increased intracranial pressure (which lowers seizure threshold)
• Implanted medication pumps
• Intracardiac lines
• Significant heart disease defined as heart disease that causes moderate to severe symptoms and/or is characterized by moderate to severe pathology, including a recent history of myocardial infarction and heart failure with an ejection fraction of less than 30% or with a New York Heart Association Functional Classification of Class III or IV.
• Bipolar disorder (to reduce the risk of mania)
• History of suicide attempt(s)
• Family history of epilepsy
• Heavy alcohol consumption within the past 48 hours
• Permanent makeup or tattoos with metallic dyes