Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder

Optimized Multichannel tDCS Protocol vs Conventional and Sham tDCS for Clinical Use in Patients With 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.

Study Overview

• Status: Completed
• Conditions: Depressive Disorder; Cognitive Impairment; Psychiatric Disorder
• Intervention / Treatment: Device: transcranial direct current stimulation (tDCS); Device: multichannel transcranial direct current stimulation (tDCS)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran
  • Zanjan Province
    • Zanjan, Zanjan Province, Iran
      • Zanjan University of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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.
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); 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.
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montgomery-Asberg Depression Rating Scale scores	the score on the MADRS (Montgomery-Asberg Depression Rating Scale)	up to 3 months after the intervention
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	up to 3 months after the intervention
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	up to 3 months after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Working memory task	Performance in the Spatial Working Memory (SWM) task, which is a recommended test for depression by Cambridge Cognition (CANTAB)	up to 1 month after the intervention
Attention task	Performance in the Rapid Visual Information Processing (RVP) task, which is a recommended test for depression by Cambridge Cognition (CANTAB)	up to 1 month after the intervention
Emotion Recognition Task	Performance in the Emotion Recognition Task (ERT), which is a recommended test for depression by Cambridge Cognition (CANTAB)	up to 1 month after the intervention
electroencephalogram (EEG) functional connectivity	Change in the EEG functional connectivity in the frontal areas	up to 1 week after the intervention
electroencephalogram (EEG) power	Change in the EEG alpha/theta/gamma power	up to 1 week after the intervention

Collaborators and Investigators

• Sponsor: The National Brain Mapping Laboratory (NBML)
• Collaborators: RWTH Aachen University; Neuroelectrics Corporation; Leibniz Research Centre for Working Environment and Human Factors; Zanjan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): December 1, 2022
• Study Completion (Actual): March 1, 2023

Study Registration Dates

• First Submitted: November 24, 2023
• First Submitted That Met QC Criteria: December 2, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: tDCS; major depressive disorder
• Additional Relevant MeSH Terms: Neurocognitive Disorders; Cognition Disorders; Mood Disorders; Cognitive Dysfunction; Depressive Disorder; Mental Disorders; Depressive Disorder, Major; Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: ifado-NE-ZUMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No