Transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy: study protocol for a pilot randomized controlled trial

Abstract

BackgroundWomen with depression in pregnancy are faced with difficult treatment decisions. Untreated, antenatal depression has serious negative implications for mothers and children. While antidepressant drug treatment is likely to improve depressive symptoms, it crosses the placenta and may pose risks to the unborn child. Transcranial direct current stimulation is a focal brain stimulation treatment that improves depressive symptoms within 3 weeks of treatment by inducing changes to brain areas involved in depression, without impacting any other brain areas, and without inducing changes to heart rate, blood pressure or core body temperature. The localized nature of transcranial direct current stimulation makes it an ideal therapeutic approach for treating depression during pregnancy, although it has never previously been evaluated in this population.Methods/designWe describe a pilot randomized controlled trial of transcranial direct current stimulation among women with depression in pregnancy to assess the feasibility of a larger, multicentre efficacy study. Women over 18 years of age and between 14 and 32 weeks gestation can be enrolled in the study provided they meet diagnostic criteria for a major depressive episode of at least moderate severity and have been offered but refused antidepressant medication. Participants are randomized to receive active transcranial direct current stimulation or a sham condition that is administered in 15 30-minute treatments over three weeks. Women sit upright during treatment and receive obstetrical monitoring prior to, during and after each treatment session. Depressive symptoms, treatment acceptability, and pregnancy outcomes are assessed at baseline (prior to randomization), at the end of each treatment week, every four weeks post-treatment until delivery, and at 4 and 12 weeks postpartum.DiscussionTranscranial direct current stimulation is a novel therapeutic option for treating depression during pregnancy. This protocol allows for assessment of the feasibility of, acceptability of and adherence with a clinical trial protocol to administer this treatment to pregnant women with moderate to severe depression. Results from this pilot study will guide the development of a larger multicentre trial to definitively test the efficacy and safety of transcranial direct current stimulation for pregnant women with depression.Trial registrationClinical Trials Gov NCT02116127.

Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

“…A calculation of current intensities arriving at different parts of the body (e.g., heart, uterus) during transcranial stimulation has not been performed yet. There are only two published case reports of pregnant women who underwent tDCS treatment for depression and hallucinations related to schizophrenia (Shenoy et al, 2015; Vigod et al, 2014). The first case reported was a 25-year-old woman with schizophrenia (DSM-IV) and drug non-responsive auditory verbal hallucinations (Shenoy et al, 2015).…”

Transcranial Direct Current Stimulation (tDCS) for Depression during Pregnancy: Scientific Evidence and What Is Being Said in the Media—A Systematic Review

“…The patients were treated at the Mount Sinai Hospital Toronto, Canada, for 30 minutes with active 2 mA tDCS [2]. The study results will be published in the near future (NCT02116127).…”

The Escitalopram versus Electric Current Therapy for Treating Depression Clinical Study (ELECT-TDCS): rationale and study design of a non-inferiority, triple-arm, placebo-controlled clinical trial

“…pregnant women, 86 HIV patients 87 and patients presenting clinical conditions in which the pharmacokinetic interactions are problematic. 88 Our study is also interesting from a cost-efficacy perspective, since tDCS is an affordable, portable and ease-to-use therapy.…”