Depressive DisorderNCT06165445
Optimizing tDCS Protocol for Clinical Use in Major Depressive Disorder
A study testing transcranial direct current stimulation (tDCS) and multichannel transcranial direct current stimulation (tDCS) in people with Depressive Disorder and Cognitive Impairment, run by The National Brain Mapping Laboratory (NBML) at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depressive Disorder, Cognitive Impairment, Psychiatric Disorder
- What is being tested?
- transcranial direct current stimulation (tDCS) and multichannel transcranial direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIran
- Study dates
- 1 Jun 2021to 1 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- transcranial direct current stimulation (tDCS), multichannel transcranial direct current stimulation (tDCS)
- Keywords
- major depressive disorder, tDCS
- Medical subject headings
- Depressive Disorder, Cognitive Dysfunction, Mental Disorders, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: transcranial direct current stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale scores
the score on the MADRS (Montgomery-Asberg Depression Rating Scale)
Measured: 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
Measured: 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
Measured: up to 3 months after the intervention
Secondary outcomes (5)
Working memory task
Performance in the Spatial Working Memory (SWM) task, which is a recommended test for depression by Cambridge Cognition (CANTAB)
Measured: 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)
Measured: 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)
Measured: up to 1 month after the intervention
electroencephalogram (EEG) functional connectivity
Change in the EEG functional connectivity in the frontal areas
Measured: up to 1 week after the intervention
electroencephalogram (EEG) power
Change in the EEG alpha/theta/gamma power
Measured: up to 1 week after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Jun 2021
- Primary completion1 Dec 2022
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, double-blind, parallel group trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)
- Sponsor type
- University, hospital or other
- Collaborators
- Leibniz Research Centre for Working Environment and Human Factors, Neuroelectrics Corporation, Zanjan University of Medical Sciences, RWTH Aachen University
- Responsible party
- Principal investigator, Mohammad Ali Salehinejad, RWTH Aachen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165445
- Sponsor's protocol ID
- ifado-NE-ZUMS
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2023
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 Aug;31(8):4632-4644. doi: 10.1038/s41380-026-03560-0. Epub 2026 Apr 2.
PubMed 41927768
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Multichannel tDCS Protocol vs Conventional and Sham tDCS for Clinical Use in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT06165445
- Acronym / sponsor ID
- ifado-NE-ZUMS
- Keywords
- major depressive disorder, tDCS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The National Brain Mapping Laboratory (NBML)University, hospital or other
- Collaborators
- Leibniz Research Centre for Working Environment and Human Factors, Neuroelectrics Corporation, Zanjan University of Medical Sciences, RWTH Aachen University
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- randomized, double-blind, parallel group trial
| Arm | Type | Receives |
|---|---|---|
| conventional tDCS group | Active comparator | Device: transcranial direct current stimulation (tDCS)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 |
| multi-channel tDCS group | Active comparator | Device: multichannel transcranial direct current stimulation (tDCS)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 |
| sham tDCS group | Placebo comparator | Device: transcranial direct current stimulation (tDCS)The conventional tDCS group will receive 30 session of 20-minute placebo stimulation using standard electrodes (7 x 5 cm) over the target region |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- smoker
- pregnancy
- alcohol or substance dependence
- history of seizure
- history of neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | conventional tDCS group, sham tDCS group |
| 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. | Device | multi-channel tDCS group |
Primary outcome
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)
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
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
5 secondary outcomes
Working memory task
Time frame: up to 1 month after the intervention
Attention task
Time frame: up to 1 month after the intervention
Emotion Recognition Task
Time frame: up to 1 month after the intervention
electroencephalogram (EEG) functional connectivity
Time frame: up to 1 week after the intervention
electroencephalogram (EEG) power
Time frame: up to 1 week after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Derived from this study: PubMed 41927768Salehinejad 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 Aug;31(8):4632-4644. doi: 10.1038/s41380-026-03560-0. Epub 2026 Apr 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation (tDCS) and multichannel transcranial direct current stimulation (tDCS) in people with Depressive Disorder and Cognitive Impairment, run by The National Brain Mapping Laboratory (NBML) at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale scores (time frame: up to 3 months after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06165445, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026; AzTrials last refreshed its copy on 29 Oct 2026.