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N/A N=15 Supportive Care

Neuropathic Pain in Pregnancy

Pain · Pregnancy

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

OutcomeResultp-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
View full record on ClinicalTrials.gov →

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.

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