Brain Stimulation + Cognitive Behavioral Therapy for Depression
Recruiting in Palo Alto (17 mi)
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.
12345Is 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.
678910How 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.
1461112Eligibility 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
+2 more
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
Participant Groups
The 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.
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
Research Locations NearbySelect from list below to view details:
University of ManitobaWinnipeg, Canada
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Who Is Running the Clinical Trial?
University of ManitobaLead Sponsor
Winnipeg FoundationCollaborator
References
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.
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) has shown mixed results for depression treatment. The efficacies of tDCS combination therapies have not been investigated deliberately. This review aims to evaluate the clinical efficacy of tDCS as a monotherapy and in combination with medication, psychotherapy, and ECT for treating adult patients with major depressive disorder (MDD) and identified the factors influencing treatment outcome measures (i.e. depression score, dropout, response, and remission rates).
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 (tDCS), a relatively new neuromodulation approach, provides some evidence of an antidepressant effect. This randomized, 4-week, double-blind study with 8-week, open-label, follow-up compared the efficacy and tolerability of left anodal tDCS with venlafaxine ER (VNF) in the treatment of depression and prevention of early relapse.
Transcranial direct current stimulation based on quantitative electroencephalogram combining positive psychotherapy for major depression. [2018]Frontal cortex activity is reduced in the left hemisphere during depression. Transcranial direct current stimulation is a noninvasive neuromodulation technique that can increase frontal cortex activity. Therapy based on transcranial Direct Current Stimulation and positive psychology therapy was applied for improving patients’ quality of life. The present study compared three conditions of subjects with clinical depression; (a) transcranial Direct Current Stimulation therapy, (b) positive psychotherapy, and(c) combined treatment. Hamilton Depression Rating Scale, Adult State Hope Scale and Optimism/Pessimism Scale was used at baseline, 2-week, 4-week, and 3-month follow-up. Combined condition participants showed greater reduction in depressed mood, improved hope and optimism after 4-weeks as well as during 3-month follow-up than the other conditions. Results are discussed in terms of additive or synergistic relation between transcranial direct current stimulation and positive psychology treatment.
Transcranial direct current stimulation in treatment resistant depression: a randomized double-blind, placebo-controlled study. [2022]Anodal transcranial direct current stimulation (tDCS) of the prefrontal cortex has been proposed as therapeutic intervention in major depression. According to clinical needs, this study addresses the question whether tDCS is effective in treatment resistant major depressive episodes.
Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data. [2019]Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation modality that has been increasingly used for major depressive disorder (MDD) treatment. Although studies in healthy volunteers showed that the technique is well-tolerated, tDCS safety and acceptability have not been sufficiently explored in patients with MDD.
Safety of transcranial direct current stimulation in healthy participants. [2021]•Transcranial Direct Current Stimulation (tDCS) is mostly reported as safe.•BUT it could induce life-changing conditions in healthy volunteers.•Scientific community MUST be warned that tDCS may be harmful and protect healthy volunteers.
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation investigated as a treatment for several neuropsychiatric disorders. Notwithstanding tDCS-induced adverse events (AEs) are considered to be low and transient, systematic review analyses on safety and tolerability of tDCS derive mostly from single-session studies.
Tolerability and blinding of high-definition transcranial direct current stimulation among older adults at intensities of up to 4 mA per electrode. [2023]Few studies have investigated tolerability, blinding, and double-blinding of High-Definition transcranial Direct Current Stimulation (HD-tDCS) at amplitudes above 2 milliamps (mA).
tDCS for the treatment of depression: a comprehensive review. [2018]Transcranial direct current stimulation (tDCS) has been investigated for the treatment of major depressive disorders in recent years. Here, we review the implications of current research for the clinical use of tDCS in the treatment of major depressive disorder. Meta-analyses, randomized, placebo-controlled clinical trials, open-label trials, case reports and review articles were identified through a systematic search of the literature database of the National Institutes of Health (USA). Available articles were evaluated with regard to their clinical relevance. Results of tDCS efficacy are inconsistent due to the small sample sizes, the heterogeneous patient samples and the partially high treatment resistance in some studies. Overall, tDCS has very low side effects. Meta-analyses suggest some efficacy of tDCS in the treatment of acute depressive disorder with moderate effect size, and low efficacy in treatment-resistant depression. A general statement about the efficacy of tDCS as a therapeutic tool in major depression seems to be premature. tDCS is considered as a safe therapeutic option and is associated with only minor side effects. The effectiveness of tDCS decreases with resistance to treatment. Psychotropic drugs may attenuate or amplify its effects. The use of 2 mA current strength over 20 min per day over a short time span can be considered as safe.
Transcranial direct current stimulation as a therapeutic tool for the treatment of major depression: insights from past and recent clinical studies. [2009]Transcranial direct current stimulation (tDCS) is a noninvasive method of brain stimulation that has been increasingly tested for the treatment of neuropsychiatric disorders. It has useful characteristics, such as low cost, ease of use, reliable sham methodology, and relatively powerful effects on cortical excitability. Because of its potential to modulate cortical excitability noninvasively, tDCS has been tested for the treatment of depression for several decades. Therefore, we reviewed evidence on the use of tDCS for major depression examining evidence from past and recent tDCS studies. We also briefly compared tDCS with other techniques of neuromodulation, namely deep brain stimulation, vagal nerve stimulation, and transcranial magnetic stimulation; and suggest future directions for the use of tDCS in major depression.
The Neurostimulation of the Brain in Depression Trial: Protocol for a Randomized Controlled Trial of Transcranial Direct Current Stimulation in Treatment-Resistant Depression. [2021]Major depressive disorder (MDD) is the second highest cause of disability worldwide. Standard treatments for MDD include medicine and talk therapy; however, approximately 1 in 5 Canadians fail to respond to these approaches and must consider alternatives. Transcranial direct current stimulation (tDCS) is a safe, noninvasive method that uses electrical stimulation to change the activation pattern of different brain regions. By targeting those regions known to be affected in MDD, tDCS may be useful in ameliorating treatment-resistant depression.