At-Home tDCS for Depression in Pregnancy

Recruiting at 1 trial location

Overseen By Simoe Vigod

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Women's College Hospital

Must not be taking: Benzodiazepines, Anticonvulsants

Disqualifiers: Substance use, Suicidality, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 3 weeks

156 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called transcranial direct current stimulation (tDCS) to determine its effectiveness in reducing depression symptoms in pregnant individuals. Participants will receive either the active tDCS treatment or a sham (inactive) version to compare effects. The trial focuses on those who are pregnant, experiencing moderate to severe depression, and have opted not to use antidepressant medication. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could lead to new treatment options for depression during pregnancy.

Will I have to stop taking my current medications?

The trial requires that you have not started any new treatments for depression and have not taken any depression medications in the 4 weeks before starting the study. If you are taking benzodiazepines, you can only use low-dose lorazepam up to 2mg per day.

What prior data suggests that transcranial direct current stimulation (tDCS) is safe for pregnant individuals?

Studies have shown that transcranial direct current stimulation (tDCS) is generally safe for pregnant people with depression. Research indicates that participants did not experience any serious side effects during trials. In one study, those who used tDCS expressed positive opinions about the treatment, with no negative effects reported. Other findings suggest that tDCS not only helps reduce depression symptoms during pregnancy but also lowers the risk of depression after childbirth. Overall, tDCS is considered a promising and safe option for treating depression during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for depression during pregnancy, like antidepressant medications and psychotherapy, can take weeks to show full effectiveness and may have side effects. Unlike these standard options, the active tDCS treatment is unique because it involves a non-invasive technique that delivers a mild electrical current to the brain's dorsolateral prefrontal cortex. Researchers are excited because this method has the potential to rapidly alleviate depressive symptoms without medication, making it a promising option for pregnant individuals who are concerned about medication effects on their pregnancy. Additionally, it's designed for at-home use, offering convenience and ease of access.

What evidence suggests that transcranial direct current stimulation (tDCS) is effective for depression in pregnancy?

Research has shown that transcranial direct current stimulation (tDCS) can help reduce symptoms of depression. One study found that 34% of non-pregnant patients responded positively to tDCS, compared to 19% who received a sham treatment. This trial will compare active tDCS with sham tDCS in pregnant individuals. Another study suggested that using tDCS during pregnancy might lower depression symptoms and reduce the risk of postpartum depression. Early findings also indicate that tDCS can improve depression scores without causing serious side effects. Although researchers have not fully studied tDCS in pregnant individuals, these results provide promising evidence of its potential benefits. ^{1 2 3 4 6}

Who Is on the Research Team?

Daniel Blumberger, MD

Principal Investigator

Centre for Addiction and Mental Health

Sophie Grigoriadis, MD

Principal Investigator

Sunnybrook Health Sciences Centre

Simone Vigod

Principal Investigator

Women's College Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am currently experiencing a moderate to severe depressive episode without psychosis.

I am pregnant with one baby and between 12 to 32 weeks along.

I haven't started any new depression treatments in the last 4 weeks.

Exclusion Criteria

I do not use benzodiazepines or anticonvulsants regularly, except for low-dose lorazepam.

I have visible skin issues or rashes where electrodes might be placed on my scalp.

Active alcohol or substance use disorder in previous 12 months as assessed by GAIN-SS

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Training

Participants receive at least one in-person training session with the research team to learn how to self-administer tDCS

1 week

1 visit (in-person)

Treatment

Participants self-administer 30-minute tDCS treatments 5 times per week for 3 weeks, for a total of 15 sessions

3 weeks

15 sessions (at-home)

Pregnancy Monitoring

Participants are monitored every 4 weeks during pregnancy for depressive symptoms and other health outcomes

up to 28 weeks

Postpartum Follow-up

Participants are monitored for safety and effectiveness at 4-, 12-, 26-, and 52-weeks postpartum

up to 52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• active tDCS
• sham tDCS

Trial Overview 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.

How Is the Trial Designed?

Group I: active tDCS Experimental Treatment 2 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: control Placebo Group 2 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.

active tDCS is already approved in Canada for the following indications:

Approved in Canada as tDCS for:

• Depression in pregnancy

Who Is Running the Clinical Trial?

Women's College Hospital

Lead Sponsor

Trials

108

Recruited

43,700+

Centre for Addiction and Mental Health

Collaborator

Trials

388

Recruited

84,200+

Sunnybrook Health Sciences Centre

Collaborator

Trials

693

Recruited

1,569,000+

Published Research Related to This Trial

A pilot randomized controlled trial involving 20 pregnant women with major depressive disorder showed that transcranial direct current stimulation (tDCS) is feasible and well-accepted, with no serious adverse events reported.

At 4 weeks postpartum, 75% of women who received tDCS were in remission compared to only 12.5% in the sham-control group, suggesting that tDCS may effectively improve treatment outcomes for antenatal depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for depression in pregnancy: A pilot randomized controlled trial. Vigod, SN., Murphy, KE., Dennis, CL., et al.[2020]

Transcranial electrical stimulation (tES) appears to be a safe and effective treatment for psychiatric disorders during the perinatal period, with no serious adverse effects reported for mothers or their children in a review of seven studies involving 33 women.

The systematic review and three original case reports suggest that tES, particularly transcranial direct current stimulation (tDCS), can be beneficial for conditions like bipolar depression and postpartum depression, indicating its potential as a non-pharmacological treatment option during pregnancy and breastfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Transcranial Electric Stimulation during the Perinatal Period: A Systematic Literature Review and Three Case Reports. Laurin, A., Nard, N., Dalmont, M., et al.[2022]

In a case series of 16 treatment-resistant depression patients, home-administered transcranial direct current stimulation (HA-tDCS) showed clinical benefits, with 5 out of 12 patients responding within 6 weeks and 9 maintaining improvements after 12 weeks of treatment.

HA-tDCS was found to be safe and well-tolerated, with no significant cognitive impairments reported over up to 2 years of treatment, although two patients experienced mild side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Clinical Case Series of Acute and Maintenance Home Administered Transcranial Direct Current Stimulation in Treatment-Resistant Depression. Le, B., Alonzo, A., Bull, M., et al.[2023]

Transcranial direct current stimulation (tDCS) shows promise as a treatment for major depression during pregnancy, potentially offering a safer alternative to traditional therapies that may have adverse effects on the fetus.

The review identified only 13 articles on tDCS for depression in pregnant women, indicating a need for more research to establish its efficacy and safety in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation (tDCS) for Depression during Pregnancy: Scientific Evidence and What Is Being Said in the Media-A Systematic Review. Kurzeck, AK., Kirsch, B., Weidinger, E., et al.[2020]

Transcranial direct current stimulation (tDCS) is a promising treatment for depression during pregnancy, as it targets specific brain areas involved in depression without affecting other areas or causing changes in heart rate, blood pressure, or body temperature.

This pilot randomized controlled trial aims to assess the feasibility and acceptability of tDCS in pregnant women with moderate to severe depression who have refused antidepressant medication, paving the way for a larger study to evaluate its efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for treatment of major depression during pregnancy: study protocol for a pilot randomized controlled trial. Vigod, S., Dennis, CL., Daskalakis, Z., et al.[2022]

A randomized controlled trial (HomeDC) on the use of transcranial direct current stimulation (tDCS) at home for major depressive disorder was prematurely terminated due to safety concerns, specifically skin lesions in patients, highlighting the need for better safety monitoring.

Although the study showed significant reductions in depression scales over time, active tDCS did not demonstrate superior efficacy compared to sham tDCS, indicating that further high-quality research is necessary to explore the potential of tDCS for treating depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TDCS at home for depressive disorders: an updated systematic review and lessons learned from a prematurely terminated randomized controlled pilot study. Kumpf, U., Palm, U., Eder, J., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31257092/

Transcranial direct current stimulation (tDCS) for ... Transcranial direct current stimulation (tDCS), a non-invasive brain stimulation treatment for depression, has not been evaluated in pregnancy.

2. womensmentalhealth.org womensmentalhealth.org/posts/tdcs-pregnancy/

Transcranial Direct Current Stimulation for Depression ... This study suggests that tDCS administered during pregnancy leads to reductions in depressive symptoms and simultaneously reduces risk for postpartum depression ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1935861X19302736

Transcranial direct current stimulation (tDCS) for ... A recent meta-analysis of 6 trials (289 non-pregnant patients with depression) found active tDCS superior to sham-control with response rates of 34% vs. 19%, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05097586

RCT of At-Home tDCS for Depression in Pregnancy This is a randomized, sham-controlled trial to determine whether treatment with transcranial direct current stimulation (tDCS) is superior to a sham ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8304475/

Transcranial Direct Current Stimulation (tDCS) for ... The results showed a significant improvement of HAMD and BDI in six patients undergoing Phase 1 and tDCS was well tolerated without any serious ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6119899/

Transcranial Direct Current Stimulation (tDCS) for ... However, all articles deemed tDCS as a potentially helpful treatment method for depressed women during pregnancy that was “safe and effective” [ ...