N/A
N=15
Neuropathic Pain in Pregnancy
Pain · Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02608463 ↗Enrolled (actual)
15
Serious AEs
40.0%
Results posted
Sep 2020
Primary outcome: Primary: Change From Baseline Visual Analogue Scale for Pain — -0.57; -14.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- painDETECT Questionnaire (Behavioral); Pain Catastrophizing Scale (Behavioral); Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale (Behavioral); Beck Depression Inventory (Behavioral); Visual Analogue Scale (Behavioral); Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale (Behavioral); Transcranial Magnetic Stimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Arkansas
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Visual Analogue Scale for Pain |
-0.57; -14.4 | — |
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.
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.