At-Home tDCS for Depression in Pregnancy

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Sophie Grigoriadis, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Women's College Hospital

Must not be taking: Benzodiazepines, Anticonvulsants

Disqualifiers: Substance use, Suicidality, Bipolar, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of this treatment for depression during pregnancy?

Research suggests that transcranial direct current stimulation (tDCS) could be a promising treatment for depression during pregnancy due to its localized effect on the brain and lack of serious side effects. While studies specifically on pregnant women are limited, tDCS has shown potential in improving depressive symptoms in other populations, and its safety profile makes it an attractive option for pregnant women who want to avoid medication.

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Is at-home transcranial direct current stimulation (tDCS) safe for use during pregnancy?

Transcranial direct current stimulation (tDCS) is generally considered safe, with no serious adverse effects reported in studies involving pregnant women with psychiatric conditions. However, a study on at-home tDCS for depression was stopped early due to skin lesions, highlighting the need for careful safety monitoring.

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How does the treatment tDCS for depression in pregnancy differ from other treatments?

tDCS is unique because it is a non-invasive brain stimulation treatment that targets specific brain areas involved in depression without affecting other parts of the body, making it potentially safer for pregnant women compared to traditional antidepressant drugs that can cross the placenta and pose risks to the unborn child.

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Eligibility Criteria

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 am 18 years old or older.

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

Trial Timeline

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

Participant Groups

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.

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Women's College Hospital Toronto, Canada

Sunnybrook Health Sciences Centre Toronto, Canada

Who Is Running the Clinical Trial?

Women's College Hospital Lead Sponsor

Centre for Addiction and Mental Health Collaborator

Sunnybrook Health Sciences Centre Collaborator

References

1. Switzerland 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. [2020] Major depression is the most frequent morbidity in pregnancy. The first-line therapies, psychopharmacologic treatment and psychotherapy, are either insufficient or may cause severe or teratogenic adverse events. As a result of its local limitation to the patient's brain, transcranial direct current stimulation (tDCS) could potentially be an ideal treatment for pregnant women with depression. A literature search was conducted in medical databases, globally published newspapers, search engines, and clinical trial registers to collect all articles on tDCS for the treatment of depression during pregnancy. The aim of this review was to investigate the scientific evidence of tDCS use for depression during pregnancy and to compare these results with the textual and emotional perception in the media as interventions during pregnancy are under particular surveillance. We detected 13 medical articles dealing with tDCS for depression in pregnancy. Overall, the scientific evidence as well as articles in the media for tDCS in pregnancy are sparse, but promising. Further studies are required in this specifically vulnerable population of pregnant women to generate evidence. It is likely that public interest will increase when the results of a pilot study in Canada are published.

2. Germany 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. [2023] The application of transcranial direct current stimulation (tDCS) at home for the treatment of major depressive disorder (MDD) is the subject of current clinical trials. This is due to its positive safety profile, cost-effectiveness, and potential scalability for a wide outreach in clinical practice. Here, we provide a systematic review of the available studies and also a report on the results of a randomized controlled trial (RCT) on tDCS at home for the treatment of MDD. This trial had to be prematurely terminated due to safety concerns. The HomeDC trial is a double-blinded, placebo-controlled, parallel-group study. Patients with MDD (DSM-5) were randomized to active or sham tDCS. Patients conducted tDCS at home for 6 weeks with 5 sessions/week (30 min at 2 mA) anode over F3, cathode over F4. Sham tDCS resembled active tDCS, with ramp-in and ramp-out periods, but without intermittent stimulation. The study was prematurely terminated due to an accumulation of adverse events (AEs, skin lesions), so that only 11 patients were included. Feasibility was good. Safety monitoring was not sufficient enough to detect or prevent AEs within an appropriate timeframe. Regarding antidepressant effects, the reduction in depression scales over time was significant. However, active tDCS was not superior to sham tDCS in this regard. Both the conclusions from this review and the HomeDC trial show that there are several critical issues with the use of tDCS at home that need to be addressed. Nevertheless the array of transcranial electric simulation (TES) methods that this mode of application offers, including tDCS, is highly interesting and warrants further investigation in high quality RCTs.

3. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Transcranial Electric Stimulation during the Perinatal Period: A Systematic Literature Review and Three Case Reports. [2022] Introduction: The perinatal period is an at-risk period for the emergence or decompensation of psychiatric disorders. Transcranial electrical stimulation (tES) is an effective and safe treatment for many psychiatric disorders. Given the reluctance to use pharmacological treatments during pregnancy or breastfeeding, tES may be an interesting treatment to consider. Our study aims to evaluate the efficacy and safety of tES in the perinatal period through a systematic literature review followed by three original case reports. Method: Following PRISMA guidelines, a systematic review of MEDLINE and ScienceDirect was undertaken to identify studies on tES on women during the perinatal period. The initial research was conducted until 31 December 2021 and search terms included: tDCS, transcranial direct current stimulation, tACS, transcranial alternating current stimulation, tRNS, transcranial random noise stimulation, pregnancy, perinatal, postnatal, and postpartum. Results: Seven studies reporting on 33 women during the perinatal period met the eligibility criteria. No serious adverse effects for the mother or child were reported. Data were limited to the use of tES during pregnancy in patients with schizophrenia or unipolar depression. In addition, we reported three original case reports illustrating the efficacy and safety of tDCS: in a pregnant woman with bipolar depression, in a pregnant woman with post-traumatic stress disorder (sham tDCS), and in a breastfeeding woman with postpartum depression. Conclusions: The results are encouraging, making tES a potentially safe and effective treatment in the perinatal period. Larger studies are needed to confirm these initial results, and any adverse effects on the mother or child should be reported. In addition, research perspectives on the medico-economic benefits of tES, and its realization at home, are to be investigated in the future.

4. United States pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation (tDCS) for depression in pregnancy: A pilot randomized controlled trial. [2020] Depression in pregnancy negatively affects maternal-child health. Transcranial direct current stimulation (tDCS), a non-invasive brain stimulation treatment for depression, has not been evaluated in pregnancy.

5. England 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. [2022] Women 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.

6. United States pubmed.ncbi.nlm.nih.gov

A Clinical Case Series of Acute and Maintenance Home Administered Transcranial Direct Current Stimulation in Treatment-Resistant Depression. [2023] Transcranial direct current stimulation (tDCS) is a noninvasive neurostimulation technique being translated clinically for the treatment of depression. There is limited research documenting the longer-term effectiveness and safety of tDCS treatment. This case series is the first report of remotely supervised, home-administered tDCS (HA-tDCS) for depression in a clinical setting.