~4 spots leftby Aug 2025

Brain Stimulation + Cognitive Behavioral Therapy for Depression

Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Manitoba
Disqualifiers: Metallic implants, Claustrophobia, others
No Placebo Group
Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of the proposed study is to examine if a repeated treatment of High Definition Transcranial Direct Current Stimulation (HD-tDCS) can increase the functional connectivity between the left ventrolateral prefrontal cortex and posterior cingulate, which may further enhance the effects of cognitive behavioral therapy with mindfulness classes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment HD-tDCS for depression?

Research shows that transcranial direct current stimulation (tDCS), a part of HD-tDCS, can help improve symptoms of depression, especially when combined with other therapies like positive psychotherapy. Studies have found that people receiving combined treatments often experience greater mood improvements and increased hope and optimism.12345

Is brain stimulation with tDCS safe for humans?

Transcranial direct current stimulation (tDCS) is generally considered safe for humans, with very low and minor side effects reported. However, there are warnings that it could potentially cause serious conditions in healthy individuals, so caution is advised.678910

How does the Brain Stimulation + Cognitive Behavioral Therapy treatment for depression differ from other treatments?

This treatment is unique because it combines transcranial direct current stimulation (tDCS), a non-invasive method that uses electrical currents to stimulate specific brain areas, with cognitive behavioral therapy (CBT), a type of talk therapy. This combination aims to enhance the effects of each component, potentially offering a more effective approach for those who do not respond to standard treatments like medication or CBT alone.1461112

Eligibility Criteria

This trial is for individuals in Manitoba enrolled in virtual mental health programs, such as CBT or DBT, or those who provide these services. It's not suitable for people with MRI contraindications like metallic implants or claustrophobia.

Inclusion Criteria

I am enrolled in mental health programs like CBT or group therapy.
Patients who have agreed to participate in virtual mental health treatment at health care sites throughout Manitoba
Must be located within Manitoba
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Exclusion Criteria

Contraindication for MRI (e.g., metallic implants and claustrophobia)

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive repeated treatment of High Definition Transcranial Direct Current Stimulation (HD-tDCS) combined with cognitive behavioral therapy and mindfulness classes

5 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • HD-tDCS (Non-invasive Brain Stimulation)
Trial OverviewThe study tests if brain stimulation using the MxN-9 HD-tES device can boost the effects of cognitive behavioral therapy and mindfulness classes by improving brain connectivity.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Active StimulationActive Control1 Intervention
MxN-9 HD-tES Stimulator (Soterix Inc.) will be used to deliver direct current (High-Definition Transcranial Direct Current Stimulation) to the target brain areas via electrodes and conducive gels. A constant current will be applied for 20 minutes with peak current of 2 mA. The 9 electrodes (8 channels + 1 ground) positions and current intensity have been determined based on computer simulation using HDTargets software (Soterix Inc.) that results in maximum focal current on the left VLPFC (x=-50, y=+26, z=+8) and the PCC (x=1, y=-61, z=38) with inward field orientation.
Group II: Inactive StimulationPlacebo Group1 Intervention
The current will be applied for 30 seconds ramp-up followed by 30 seconds ramp-down, and thus no active stimulation will be administered except for the initial and last 1 minutes of 20 minute stimulation duration.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+

Winnipeg Foundation

Collaborator

Trials
2
Recruited
90+

Findings from Research

Transcranial direct current stimulation (tDCS) significantly reduced depression scores compared to sham treatment, with the most effective results seen when tDCS was combined with medication, particularly selective serotonin re-uptake inhibitors (SSRIs).
The study included 12 randomized, sham-controlled trials with 251 participants receiving active tDCS and 204 receiving sham, showing that while tDCS alone or combined with psychotherapy did not significantly improve outcomes, the combination with medication led to a higher response rate and a greater reduction in depression scores.
Is transcranial direct current stimulation, alone or in combination with antidepressant medications or psychotherapies, effective in treating major depressive disorder? A systematic review and meta-analysis.Wang, J., Luo, H., Schülke, R., et al.[2022]
In a randomized study of 57 participants, both transcranial direct-current stimulation (tDCS) and venlafaxine ER (VNF) showed similar efficacy in reducing depression symptoms, with no significant differences in the Montgomery-Åsberg Depression Rating Scale scores after 4 weeks.
The response and remission rates were also comparable between tDCS (24% response, 17% remission) and VNF (43% response, 32% remission), suggesting that tDCS may be a viable alternative treatment for depression, although further research is needed to confirm its clinical effectiveness.
Transcranial Direct-Current Stimulation (tDCS) Versus Venlafaxine ER In The Treatment Of Depression: A Randomized, Double-Blind, Single-Center Study With Open-Label, Follow-Up.Bares, M., Brunovsky, M., Stopkova, P., et al.[2022]
Transcranial direct current stimulation (tDCS) combined with positive psychotherapy significantly improved mood, hope, and optimism in patients with clinical depression, showing greater benefits than either treatment alone after 4 weeks and at a 3-month follow-up.
The study utilized standardized scales to measure outcomes in participants, indicating that the combination of tDCS and positive psychology may have a synergistic effect in enhancing treatment efficacy for depression.
Transcranial direct current stimulation based on quantitative electroencephalogram combining positive psychotherapy for major depression.Khayyer, Z., Ngaosuvan, L., Sikström, S., et al.[2018]

References

A Clinical Case Series of Acute and Maintenance Home Administered Transcranial Direct Current Stimulation in Treatment-Resistant Depression. [2023]
Is transcranial direct current stimulation, alone or in combination with antidepressant medications or psychotherapies, effective in treating major depressive disorder? A systematic review and meta-analysis. [2022]
Transcranial Direct-Current Stimulation (tDCS) Versus Venlafaxine ER In The Treatment Of Depression: A Randomized, Double-Blind, Single-Center Study With Open-Label, Follow-Up. [2022]
Transcranial direct current stimulation based on quantitative electroencephalogram combining positive psychotherapy for major depression. [2018]
Transcranial direct current stimulation in treatment resistant depression: a randomized double-blind, placebo-controlled study. [2022]
Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data. [2019]
Safety of transcranial direct current stimulation in healthy participants. [2021]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode. [2023]
tDCS for the treatment of depression: a comprehensive review. [2018]
11.United Statespubmed.ncbi.nlm.nih.gov
Transcranial direct current stimulation as a therapeutic tool for the treatment of major depression: insights from past and recent clinical studies. [2009]
The Neurostimulation of the Brain in Depression Trial: Protocol for a Randomized Controlled Trial of Transcranial Direct Current Stimulation in Treatment-Resistant Depression. [2021]