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Device

At-Home tDCS for Depression in Pregnancy

N/A
Recruiting
Led By Simone Vigod, MD, MSc
Research Sponsored by Women's College Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
In a major depressive episode (MDE) with at least moderate symptom severity (PHQ-9 ≥10 and confirmed using MINI International Neuropsychiatric Interview as MDE without psychotic features)
Singleton pregnancy, 12 to end of 32 weeks single gestation at randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of week 1, week 2 and week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)
Awards & highlights

Study Summary

This trial will compare transcranial direct current stimulation (tDCS) against a sham condition to see if it is more effective at reducing symptoms of depression in pregnant people with moderate to severe depression. 156 participants will be enrolled at various data collection points throughout pregnancy and up to one year postpartum.

Who is the study for?
This trial is for pregnant individuals over 18 with moderate to severe depression, between 12-32 weeks into their pregnancy. They must have declined antidepressants and not started any new treatments for depression in the last month. Exclusions include active suicidality, bipolar disorder, major pregnancy complications, metal or electrical implants in the head, certain medication use that affects tDCS treatment, non-intact scalp skin, inability to consent in English or complete a workbook in French/English.Check my eligibility
What is being tested?
The study tests if transcranial direct current stimulation (tDCS) can reduce depression symptoms better than a sham (fake) treatment during pregnancy. Participants are randomly assigned to receive either active tDCS or sham alongside a workbook therapy. The effects will be monitored throughout pregnancy and up until one year postpartum.See study design
What are the potential side effects?
Possible side effects of tDCS may include discomfort at the electrode sites on the scalp like itching or tingling sensations during application; headache; fatigue; nausea; and insomnia. These side effects are generally mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am currently experiencing a moderate to severe depressive episode without psychosis.
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I am pregnant with one baby and between 12 to 32 weeks along.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of week 1, week 2 and week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of week 1, week 2 and week 3 of treatment, q4 weeks during pregnancy (up to 28 weeks), and 4-, 12-, 26- and 52-weeks postpartum (up to 80 weeks) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Depressive symptoms post treatment
Secondary outcome measures
Child Development
Depressive symptoms
Dyadic Relationship
+11 more
Other outcome measures
Concurrent Health Service Use
Integrity of Treatment Blindness Questionnaire
Stanford Expectancy Scale
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: active tDCSExperimental Treatment2 Interventions
2mA of direct current delivered to the dorsolateral prefrontal cortex for 30 minutes each, 5 times per week for 3 weeks, for a total of 15 sessions using the Soterix Medical tDCS mini-CT model 1601-LTE.
Group II: controlPlacebo Group2 Interventions
Sham stimulation where the current is turned off after 30 seconds in a slow ramp down, delivered to the dorsolateral prefrontal cortex for 30 minutes each, 5 times per week for 3 weeks, for a total of 15 sessions using the Soterix Medical tDCS mini-CT model 1601-LTE.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
active tDCS
2018
N/A
~790

Find a Location

Who is running the clinical trial?

Women's College HospitalLead Sponsor
99 Previous Clinical Trials
38,615 Total Patients Enrolled
Centre for Addiction and Mental HealthOTHER
351 Previous Clinical Trials
80,660 Total Patients Enrolled
Sunnybrook Health Sciences CentreOTHER
654 Previous Clinical Trials
1,543,141 Total Patients Enrolled

Media Library

active tDCS (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05097586 — N/A
Pregnancy Research Study Groups: active tDCS, control
Pregnancy Clinical Trial 2023: active tDCS Highlights & Side Effects. Trial Name: NCT05097586 — N/A
active tDCS (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05097586 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this research still possible?

"According to the official data published on clinicaltrials.gov, this research project is still open for participants and was first announced on November 8th 2021 with an update being made as recently as February 3rd 2022."

Answered by AI

What is the current intake capacity of this experiment?

"Affirmative. Clinicaltrials.gov's data confirms that, as of February 3rd 2022, this medical experiment is actively seeking patients to complete their trial. The initial posting was on November 8th 2021 and the team needs 156 participants across two different sites in order to complete the study successfully."

Answered by AI

Who else is applying?

What site did they apply to?
Women's College Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Want to learn more.
PatientReceived 2+ prior treatments
~47 spots leftby Mar 2025