Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder

NCT06165445 | Completed

• 1 other identifier: ifado-NE-ZUMS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Disorder; Cognitive Impairment; Psychiatric Disorder

Keywords

major depressive disorder; tDCS

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Working memory task

  up to 1 month after the intervention

• Attention task

  up to 1 month after the intervention

• Emotion Recognition Task

  up to 1 month after the intervention

• electroencephalogram (EEG) functional connectivity

  up to 1 week after the intervention

• electroencephalogram (EEG) power

  up to 1 week after the intervention

Study Arms (3)

conventional tDCS group

ACTIVE COMPARATOR

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)

multi-channel tDCS group

ACTIVE COMPARATOR

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)

sham tDCS group

PLACEBO COMPARATOR

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

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.

conventional tDCS group; sham tDCS group

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.

multi-channel tDCS group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Zanjan University of Medical Sciences

Zanjan, Zanjan Province, Iran

Location

MeSH Terms

Conditions

Depressive Disorder; Cognitive Dysfunction; Mental Disorders; Depressive Disorder, Major

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mood Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: to secure investigator blinding, interventions were applied by independent investigators who were not involved in outcome measure ratings
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized, double-blind, parallel group trial

Study Record Dates

• First Submitted: November 24, 2023
• First Posted: December 11, 2023
• Study Start: June 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: March 1, 2023
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

IR (1)