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CompletedNCT06165445Updated Mar 18, 2026

Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder

An interventional study of transcranial direct current stimulation (tDCS) and multichannel transcranial direct current stimulation (tDCS) in Depressive Disorder, Cognitive Impairment and Psychiatric Disorder, sponsored by The National Brain Mapping Laboratory (NBML). Completed at 1 site in Iran. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by The National Brain Mapping Laboratory (NBML) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 5 months after the study started (first participant enrolled Jun 2021, registered Nov 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Depressive Disorder
  • Cognitive Impairment
  • Psychiatric Disorder

Keywords

  • major depressive disorder
  • tDCS
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

The National Brain Mapping Laboratory (NBML) is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    conventional tDCS group

    The conventional tDCS group will receive 30 sessions of 20-minute stimulation at 2 mA intensities using standard electrodes (7 x 5 cm) over the target region

    Device: transcranial direct current stimulation (tDCS)

  • Active comparator
    multi-channel tDCS group

    The multi-channel tDCS group will receive 30 sessions of 20-minute stimulation at 2 mA intensities using 7 electrodes (11 mm) over the target region

    Device: multichannel transcranial direct current stimulation (tDCS)

  • Placebo comparator
    sham tDCS group

    The conventional tDCS group will receive 30 session of 20-minute placebo stimulation using standard electrodes (7 x 5 cm) over the target region

    Device: transcranial direct current stimulation (tDCS)

Interventions

  • Devicetranscranial direct current stimulation (tDCS)

    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.

  • Devicemultichannel transcranial direct current stimulation (tDCS)

    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.

06

What researchers measure

Primary outcomes

  1. Montgomery-Asberg Depression Rating Scale scores

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

    Time frame: up to 3 months after the intervention

  2. Hamilton Depression Rating Scale scores

    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

    Time frame: up to 3 months after the intervention

  3. Beck Depression Inventory scores

    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

    Time frame: up to 3 months after the intervention

Secondary outcomes

  1. Working memory task

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

    Time frame: up to 1 month after the intervention

  2. Attention task

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

    Time frame: up to 1 month after the intervention

  3. Emotion Recognition Task

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

    Time frame: up to 1 month after the intervention

  4. electroencephalogram (EEG) functional connectivity

    Change in the EEG functional connectivity in the frontal areas

    Time frame: up to 1 week after the intervention

  5. electroencephalogram (EEG) power

    Change in the EEG alpha/theta/gamma power

    Time frame: up to 1 week after the intervention

07

Study locations

1 site
  • Zanjan University of Medical Sciences
    Zanjan, Zanjan Province, Iran
08

References and documents

Publications

  • Salehinejad MA, Abdi M, Dadashi M, Habibi M, Hallajian AH, Sharifi K, Khadem A, Salvador R, Ruffini G, Nitsche MA. Optimized multichannel 4 mA vs conventional transcranial direct current stimulation for major depressive disorder: A randomized sham-controlled trial. Mol Psychiatry. 2026 Apr 2. doi: 10.1038/s41380-026-03560-0. Online ahead of print. PubMed 41927768 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06165445
Lead sponsor
The National Brain Mapping Laboratory (NBML)
Collaborators
Leibniz Research Centre for Working Environment and Human Factors, Neuroelectrics Corporation, Zanjan University of Medical Sciences, RWTH Aachen University
Responsible party
Mohammad Ali Salehinejad (Principal Investigator, RWTH Aachen University) — Principal investigator
First posted
Dec 11, 2023
Start date
Jun 1, 2021
Primary completion
Dec 1, 2022
Completion
Mar 1, 2023
Last update
Mar 18, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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