tDCS Brain-Stimulation for Depression
Recruiting in Palo Alto (17 mi)
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of California, Los Angeles
Must be taking: Antidepressants
Must not be taking: Anticonvulsants, Lithium, Psychostimulants, others
Disqualifiers: Pregnancy, Substance use disorder, Neurological conditions, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Patients, physicians, and those who fund depression research are keenly interested in depression treatments that do not involve taking medications. One promising candidate treatment is transcranial direct current stimulation (tDCS), a low-cost technique that involves placing electrodes on specific scalp locations and using a 9-volt battery to cause a small amount of electricity to pass through parts of the brain. Depending on the direction of electrical flow, tDCS can make brain cells (neurons) more likely or less likely to generate their own electrical signals. When evaluated as a treatment, tDCS is typically done in daily sessions over a period of two weeks.
One of the challenges of tDCS is to work out the best possible positioning of electrodes and direction of electricity flow to gradually cause lasting changes in brain activity in ways that might be expected to improve depression. To address this challenge, the investigators are using MRI to take pictures of the brain during tDCS. This data will help us better understand the short-term effects of tDCS in depression and help us learn how to customize future treatments to cause a lasting beneficial response.
Patients with depression between the ages of 20-55 years are eligible to take part in this research. Potential participants will undergo:
1. An assessment to confirm eligibility. This will take place over a secure videoconference call lasting no more than 3 hours.
2. Two in-person study visits lasting 30 min and 2-1/2 hours respectively. In the first visit, the investigators will use the MRI to take a picture of the brain and head structure to determine appropriate locations for placing the tDCS electrodes at the start of the second visit. Following electrode placement, an MRI scan will be performed to take pictures of the brain during tDCS. Depending on the study arm,
1. Participants may receive 'active' or 'sham' tDCS. The 'sham' condition is identical to the 'active' tDCS in every way except that it involves minimal tDCS and is designed to help rule out effects unrelated to the administered tDCS electricity.
2. Participants may also be asked to perform a mental task during MRI.
All participants will be compensated $150 + parking upon completion of all study-visits.
Will I have to stop taking my current medications?
If you are on a stable antidepressant regimen, you can continue taking it as long as there has been no change in your treatment for 6 weeks before and during the trial. However, if you are taking anticonvulsants, lithium, psychostimulants, or certain other medications, you may need to stop them before participating.
What data supports the effectiveness of the treatment tDCS Brain-Stimulation for Depression?
Research shows that transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (DLPFC) can engage and modulate brain areas related to depression, with some studies indicating improvements in symptoms like anhedonia (loss of interest or pleasure). Additionally, combining tDCS with positive psychotherapy has shown greater improvements in mood and optimism over time.
12345Is transcranial direct current stimulation (tDCS) safe for humans?
Research shows that tDCS is generally safe for humans, with no reports of serious adverse effects or irreversible injury in over 33,200 sessions across various populations, including potentially vulnerable groups like children and the elderly.
45678How is tDCS treatment for depression different from other treatments?
Transcranial Direct Current Stimulation (tDCS) is unique because it is a non-invasive treatment that uses mild electrical currents to stimulate specific areas of the brain, like the left dorsolateral prefrontal cortex (DLPFC), which is involved in mood regulation. Unlike medications, tDCS directly targets brain circuits and can be administered at home under supervision, offering an alternative for those with treatment-resistant depression.
145910Eligibility Criteria
This trial is for adults aged 20-55 with depression who can consent, are either treatment-naive or on a stable antidepressant regimen without changes in the past 6 weeks. They must live near UCLA and have moderate depression scores. Excluded are pregnant individuals, non-English speakers, those with skin conditions affecting electrode placement, metal implants, severe depression, recent psychotherapy or neuromodulation therapy.Inclusion Criteria
My gender does not affect my eligibility.
I understand the information given to me and can make decisions about my health care.
I am between 20 and 55 years old.
+4 more
Exclusion Criteria
I cannot stop taking my benzodiazepine medication for 2 weeks.
Actively suicidal as defined by a score of 4 on item 3 of HAMD
I have depression linked to my serious health condition.
+14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1 day
1 visit (virtual)
Baseline Assessment
Initial MRI scan to determine electrode placement for tDCS
1 day
1 visit (in-person)
Treatment
Participants receive tDCS with MRI monitoring, potentially performing a mental task
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests tDCS brain stimulation's effect on depression by placing electrodes on the scalp to alter neuron activity. MRI scans will monitor these effects during sessions over two weeks. Participants may receive real or sham tDCS and might perform cognitive tasks during MRI to see how this technique could be tailored for treating depression.
4Treatment groups
Experimental Treatment
Group I: Right DLPFC tDCS + taskExperimental Treatment2 Interventions
Participants randomized to this arm will receive tDCS at the right DLPFC brain region. Additionally, participants will be asked to perform a mental task (2-back working memory) at the same time.
Group II: Right DLPFC tDCSExperimental Treatment1 Intervention
Participants randomized to this arm will receive tDCS at the right DLPFC brain region.
Group III: Left DLPFC tDCS + taskExperimental Treatment2 Interventions
Participants randomized to this arm will receive tDCS at the left DLPFC brain region. Additionally, participants will be asked to perform a mental task (2-back working memory) at the same time.
Group IV: Left DLPFC tDCSExperimental Treatment1 Intervention
Participants randomized to this arm will receive tDCS at the left DLPFC brain region.
Left DLPFC tDCS is already approved in European Union for the following indications:
🇪🇺 Approved in European Union as Transcranial Direct Current Stimulation for:
- Depression
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California Los Angeles (UCLA)Los Angeles, CA
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Who Is Running the Clinical Trial?
University of California, Los AngelesLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
A randomized double-blind sham-controlled study of transcranial direct current stimulation for treatment-resistant major depression. [2021]Transcranial direct current stimulation (tDCS) has demonstrated some efficacy in treatment-resistant major depression (TRD). The majority of previous controlled studies have used anodal stimulation to the left dorsolateral prefrontal cortex (DLPFC) and a control location such as the supraorbital region for the cathode. Several open-label studies have suggested effectiveness from anodal stimulation to the left DLPFC combined with cathodal stimulation to the right DLPFC. Thus, this study evaluated the efficacy of tDCS using anodal stimulation to the left DLPFC and cathodal stimulation to the right DLPFC compared to sham tDCS.
Effects of transcranial direct current stimulation for treating depression: A modeling study. [2018]Transcranial direct current stimulation (tDCS) above the left dorsolateral prefrontal cortex (lDLPFC) has been widely used to improve symptoms of major depressive disorder (MDD). However, the effects of different stimulation protocols in the entire frontal lobe have not been investigated in a large sample including patient data.
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.
A pilot study of alternative transcranial direct current stimulation electrode montages for the treatment of major depression. [2018]Typically, transcranial direct current stimulation (tDCS) treatments for depression have used bifrontal montages with anodal (excitatory) stimulation targeting the left dorsolateral prefrontal cortex (DLPFC). There is limited research examining the effects of alternative electrode montages.
In-vivo imaging of targeting and modulation of depression-relevant circuitry by transcranial direct current stimulation: a randomized clinical trial. [2021]Recent clinical trials of transcranial direct current stimulation (tDCS) in depression have shown contrasting results. Consequently, we used in-vivo neuroimaging to confirm targeting and modulation of depression-relevant neural circuitry by tDCS. Depressed participants (N = 66, Baseline Hamilton Depression Rating Scale (HDRS) 17-item scores ≥14 and <24) were randomized into Active/Sham and High-definition (HD)/Conventional (Conv) tDCS groups using a double-blind, parallel design, and received tDCS individually targeted at the left dorsolateral prefrontal cortex (DLPFC). In accordance with Ampere's Law, tDCS currents were hypothesized to induce magnetic fields at the stimulation-target, measured in real-time using dual-echo echo-planar-imaging (DE-EPI) MRI. Additionally, the tDCS treatment trial (consisting of 12 daily 20-min sessions) was hypothesized to induce cerebral blood flow (CBF) changes post-treatment at the DLPFC target and in the reciprocally connected anterior cingulate cortex (ACC), measured using pseudo-continuous arterial spin labeling (pCASL) MRI. Significant tDCS current-induced magnetic fields were observed at the left DLPFC target for both active stimulation montages (Brodmann's area (BA) 46: pHD = 0.048, Cohen's dHD = 0.73; pConv = 0.018, dConv = 0.86; BA 9: pHD = 0.011, dHD = 0.92; pConv = 0.022, dConv = 0.83). Significant longitudinal CBF increases were observed (a) at the left DLPFC stimulation-target for both active montages (pHD = 3.5E-3, dHD = 0.98; pConv = 2.8E-3, dConv = 1.08), and (b) at ACC for the HD-montage only (pHD = 2.4E-3, dHD = 1.06; pConv = 0.075, dConv = 0.64). These results confirm that tDCS-treatment (a) engages the stimulation-target, and (b) modulates depression-relevant neural circuitry in depressed participants, with stronger network-modulations induced by the HD-montage. Although not primary outcomes, active HD-tDCS showed significant improvements of anhedonia relative to sham, though HDRS scores did not differ significantly between montages post-treatment.
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]This review updates and consolidates evidence on the safety of transcranial Direct Current Stimulation (tDCS). Safety is here operationally defined by, and limited to, the absence of evidence for a Serious Adverse Effect, the criteria for which are rigorously defined. This review adopts an evidence-based approach, based on an aggregation of experience from human trials, taking care not to confuse speculation on potential hazards or lack of data to refute such speculation with evidence for risk. Safety data from animal tests for tissue damage are reviewed with systematic consideration of translation to humans. Arbitrary safety considerations are avoided. Computational models are used to relate dose to brain exposure in humans and animals. We review relevant dose-response curves and dose metrics (e.g. current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to theoretically vulnerable populations including children and the elderly, subjects with mood disorders, epilepsy, stroke, implants, and home users. Evidence from relevant animal models indicates that brain injury by Direct Current Stimulation (DCS) occurs at predicted brain current densities (6.3-13 A/m(2)) that are over an order of magnitude above those produced by conventional tDCS. To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 milliamperes, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or irreversible injury across over 33,200 sessions and 1000 subjects with repeated sessions. This includes a wide variety of subjects, including persons from potentially vulnerable populations.
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.
Fronto-extracephalic transcranial direct current stimulation as a treatment for major depression: an open-label pilot study. [2018]Several recent trials have reported transcranial direct current stimulation (tDCS) to be effective in treating depression, though the relative benefits of different electrode montages remain unexplored. Whereas all recent studies have used a bifrontal (BF) electrode montage, studies published in the 1960s and 1970s placed one electrode in an extracephalic position, with some positive reports of efficacy. This study investigated the efficacy and safety of tDCS given with a fronto-extracephalic (F-EX) montage.
Transcranial direct current stimulation (tDCS) in depression induces structural plasticity. [2023]Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique involving administration of well-tolerated electrical current to the brain through scalp electrodes. TDCS may improve symptoms in neuropsychiatric disorders, but mixed results from recent clinical trials underscore the need to demonstrate that tDCS can modulate clinically relevant brain systems over time in patients. Here, we analyzed longitudinal structural MRI data from a randomized, double-blind, parallel-design clinical trial in depression (NCT03556124, N = 59) to investigate whether serial tDCS individually targeted to the left dorso-lateral prefrontal cortex (DLPFC) can induce neurostructural changes. Significant (FWEc p
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.