RCT of At-Home tDCS for Depression in Pregnancy (NCT05097586)
Randomized Controlled Trial of At-home Transcranial Direct Current Stimulation (tDCS) for Depression in Pregnancy
🩺 Plain-English Summary (8th-Grade Level)
This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham condition at reducing the symptoms of depression in pregnant people with moderate to severe depression. The study aims to enrol 156 participants across all sites. Data collection occurs at baseline, immediately after treatment, every 4 weeks during pregnancy and 4-, 12-, 26- and 52-weeks postpartum
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (11 items).
Location: Sunnybrook Health Sciences Centre — Toronto, Ontario
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion criteria:
- Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS
- Active suicidality as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
- Bipolar disorder as assessed by MINI International Neuropsychiatric Interview
- Schizophrenia or other psychotic disorder as assessed by MINI International Neuropsychiatric Interview
- Major unstable or life-threatening medical illness (e.g. such as advanced cancer), pre-eclampsia/eclampsia in current pregnancy or neurologic illness or seizure history
- Major congenital anomalies or major obstetrical complications in current pregnancy (determined by clinical PI/Co-I assessment)
- Metal implants in cranium or any electrical implants
- Benzodiazepine (except intermittent low-dose lorazepam no more than 2mg equivalent per day) or anticonvulsant use as these interfere with anodal tDCS
- Visibly non-intact skin/rash on scalp areas at stimulation electrode sites
- Unable to consent or complete study measures in English, or unable to complete depression in pregnancy workbook (the attention-control) in French or English
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Sunnybrook Health Sciences Centre — Toronto, Ontario
- Women's College Hospital — Toronto, Ontario
📞 Contact the Study Coordinator
Phone: (416) 323-6400
Email: simone.vigod@wchospital.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Major Depression
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- Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression — Belmont, Massachusetts
- Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression — Birmingham, Alabama
- Accelerated High-Dose tDCS for Depression — Charleston, South Carolina
Explore by condition: All Major Depression clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.