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Completed

NCT Number: NCT06165445

Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder

In this project, the efficacy of different tDCS protocols in major depression will be investigated. The tDCS protocols have already been investigated in humans, and results showed that stimulation intensity has a different effect on tDCS long-term aftereffects based on the human motor cortex model. The project has three major goals: first, we want to see if the differential outcome of tDCS dosage, as present in healthy populations, can be translated to patients with major depression. Second, we want to compare the efficacy of a multi-channel novel protocol with conventional tDCS modules. Lastly, we are interested in the safety and tolerability of optimized multi-channel. The project output will be an optimized tDCS protocol for major depression treatment.

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Key information

Conditions

Depressive Disorder Cognition Disorders Cognitive Dysfunction Cognitive Impairment Depressive Disorder, Major Mental Disorders Mood Disorders Neurocognitive Disorders Psychiatric Disorder

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zanjan University of Medical Sciences

Zanjan, Zanjan Province, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet DSM-5 criteria for a moderate-to-severe major depression, primarily by a DSM-5-based structured interview by a licensed psychiatrist, confirmed by score on Hamilton Rating Scale for Depression (HAMD)
  • being 18-60 years old
  • providing written informed consent
  • If female, negative urine pregnancy test
  • Treatment naïve or on a stable standard antidepressant regimen (including selective serotonin reuptake inhibitors (SSRIs), serotonin-noradrenaline reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MOAIs) or tricyclics (TCAs)) with no change in treatment 6-weeks prior to and during the tDCS intervention

Exclusion criteria

  • smoker
  • pregnancy
  • alcohol or substance dependence
  • history of seizure
  • history of neurological disorder
  • comorbid Schizophrenia Axis I disorder, bipolar disorder, substance abuse or dependence, dementia, personality disorder
  • history of head injury
  • currently receiving any form of Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, or Acceptance and Commitment Therapy
  • Presence of ferromagnetic objects in the body that are contraindicated for brain stimulation of the head (pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips, metallic prostheses, permanent eyeliner, implanted delivery pump, or shrapnel fragments)

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

In tDCS, direct electrical currents at the intensity of interest (2 mA for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through a pair of saline-soaked sponge electrodes (7×5 cm) or via more than two but smaller round electrodes over the target regions.

multichannel transcranial direct current stimulation (tDCS)

Device

In multichannel tDCS, direct electrical currents at the intensity of interest (2 mA for example) are generated by an electrical stimulator and are noninvasively delivered to the scalp through more than two and smaller round electrodes over the target regions.

Primary outcomes

  1. Montgomery-Asberg Depression Rating Scale scores

    Time frame: up to 3 months after the intervention

    the score on the MADRS (Montgomery-Asberg Depression Rating Scale)

  2. Hamilton Depression Rating Scale scores

    Time frame: up to 3 months after the intervention

    the score on the Hamilton Depression Rating Scale (HDRS). The HDRS is a multiple-item questionnaire designed for measuring adult depression and is administered by health care professionals. It is currently the most common depression measure used worldwide. Items on the HDRS are scored from 0 to 4 or 0 to 2 depending on the symptom assessed, with high scores indicating greater symptom pathology. scores typically ranging from 15 to 20 indicate a clinical level of depressive symptomatology

  3. Beck Depression Inventory scores

    Time frame: up to 3 months after the intervention

    the score on the Beck Depression Inventory (BDI-II). The BDI is a self-reported twenty-one questions about how the subject has been feeling in the last week, and each question has four answers ranging in intensity. Scoring 19 or higher on the BDI-II is considered moderate depression

Secondary outcomes

  1. Working memory task

    Time frame: up to 1 month after the intervention

    Performance in the Spatial Working Memory (SWM) task, which is a recommended test for depression by Cambridge Cognition (CANTAB)

  2. Attention task

    Time frame: up to 1 month after the intervention

    Performance in the Rapid Visual Information Processing (RVP) task, which is a recommended test for depression by Cambridge Cognition (CANTAB)

  3. Emotion Recognition Task

    Time frame: up to 1 month after the intervention

    Performance in the Emotion Recognition Task (ERT), which is a recommended test for depression by Cambridge Cognition (CANTAB)

  4. electroencephalogram (EEG) functional connectivity

    Time frame: up to 1 week after the intervention

    Change in the EEG functional connectivity in the frontal areas

  5. electroencephalogram (EEG) power

    Time frame: up to 1 week after the intervention

    Change in the EEG alpha/theta/gamma power

Sponsors and collaborators

Lead sponsor

The National Brain Mapping Laboratory (NBML)

Other

Collaborators

  • Leibniz Research Centre for Working Environment and Human Factors
  • Neuroelectrics Corporation
  • RWTH Aachen University
  • Zanjan University of Medical Sciences

Registry information

Official study title

Optimized Multichannel tDCS Protocol vs Conventional and Sham tDCS for Clinical Use in Patients With Major Depressive Disorder

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 11, 2023
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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