Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder

NCT ID: NCT06165445

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2023-03-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

multichannel transcranial direct current stimulation (tDCS)

Intervention Type: 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.

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

Group Type: PLACEBO_COMPARATOR

transcranial direct current stimulation (tDCS)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leibniz Research Centre for Working Environment and Human Factors

OTHER

Sponsor Role: collaborator

Neuroelectrics Corporation

INDUSTRY

Sponsor Role: collaborator

Zanjan University of Medical Sciences

OTHER

Sponsor Role: collaborator

The National Brain Mapping Laboratory (NBML)

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Ali Salehinejad

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zanjan University of Medical Sciences

Zanjan, Zanjan Province, Iran

Countries

Iran

Other Identifiers

ifado-NE-ZUMS

Identifier Type: -

Identifier Source: org_study_id