N/A
Completed N=15
Neuropathic Pain in Pregnancy
Source: ClinicalTrials.gov NCT02608463 ↗Enrolled (actual)
15
Serious AEs
40.0%
Results posted
Sep 2020
Primary outcomePrimary: Change From Baseline Visual Analogue Scale for Pain — -0.57; -14.4 score on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Visual Analogue Scale for Pain |
-0.57; -14.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02608463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.