Neuropathic Pain in Pregnancy

Completed · Not applicable

Conditions studied: Pain, Pregnancy

In brief

This will be the first study to investigate the use of rTMS in the treatment of neuropathic pain in pregnancy. This study will enroll 60 pregnant subjects, age 18-45. All participants will receive treatment as usual. Subjects diagnosed with neuropathic pain will be offered rTMS as a treatment option.

Key facts

Study ID

NCT02608463

Run by

University of Arkansas

People needed

15

Starts

2016-01-01

Expected to finish

2019-04-19

Last updated by the study team

2021-06-23

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• University of Arkansas For Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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