DepressionNCT05090397
MRI-Guided High-Definition Transcranial Direct Current Stimulation (tDCS) for Depression
A study testing Transcranial Direct Current Stimulation in people with Depression, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this research is to understand how a neurostimulation technique, transcranial electrical stimulation (tES), affects brain function in adults with major depression measured with functional magnetic resonance imaging (fMRI). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Transcranial Direct Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 31 Mar 2025
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Ages between 18 and 65
- 2. Race/ethnicity: all races and ethnic groups
- 3. Sex/Gender: all
- 4. Capacity to provide informed consent
- 5. Diagnosis of Major Depressive Disorder made by volunteer's physician at least one year prior (confirmed by patient self-report)
- 6. Currently under the care of a clinician for depression (psychiatrist, psychologist, or other clinician)
- 7. Currently experiencing symptoms of depression (Patient Health Questionnaire 9, PHQ9 >4 at screening; Hamilton Depression Rating Scale 17-item, HDRS-17, score >8 at Visit 1)
- 8. Stable or no pharmacological antidepressant regimen (SSRI, SNRI, MOAI, or tricyclic/TCA) with no change in treatment 6 weeks prior to study start
Who cannot join
- 1. Ages below 18 (neurobiology is quite different in children vs. adults)
- 2. Ages above 65 (cortical excitability changes with age)
- 3. Active suicidal thoughts, ideation, or behavior with plan within the past month (HDRS-17 item 3 score 3-4)
- 4. Change in antidepressant medication within 6 weeks of study start
- 5. Diagnosis of any medical condition potentially affecting brain function: neuropsychiatric or mental disorders, other mood disorders (bipolar disorder, primary anxiety disorder, PTSD), psychotic states or disorders, developmental disorders, neurological disorders, including mild cognitive impairment, significant head injury, significant history of alcohol/substance abuse or dependence within past 12 months, chronic pain (current, or for more than one year within the past one year), other major medical conditions (e.g., cancer, stroke).
- 6. MRI contraindications: metal or other implants that are not MR-safe, claustrophobia, pregnancy or suspected pregnancy
Show all 11Show fewer
- 7. tES contraindications: skin conditions or injuries on the scalp hair extensions, wigs, braids, etc. that cannot be removed prior to the study, metal implants or pacemakers (also contraindicated for MRI)
- 8. Non-English speakers (due to written consent and questionnaires administered)
- 9. Neurostimulation or neuromodulation treatment for any reason within the past 3 months
- 10. Current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics.
- 11. Prisoners will not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applied Strategies for MRI-Guided High-Definition tDCS for Major Depression
The purpose of this research is to understand how a neurostimulation technique, transcranial electrical stimulation (tES), affects brain function in adults with major depression measured with functional magnetic resonance imaging (fMRI). This study targets a specific kind of tES called transcranial direct current stimulation (tDCS), where a mild, constant current is passed between electrodes placed on the scalp.
Read the detailed description
This is an investigator-initiated MRI research study of a noninvasive neurostimulation technique, transcranial direct current stimulation (tDCS) using focal "high definition" (HD) electrodes positioned using pre-treatment MRI. Primary objective is to measure changes in brain function during MRI-guided HDtDCS with MRI. Secondary objective is to measure changes in depressive symptoms after five consecutive days of MRI-guided tDCS (20 minutes per session).
- Conditions
- Depression
- Being tested
- Transcranial Direct Current Stimulation, Sham Transcranial Direct Current Stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationDevice
Transcranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions).
Sham Transcranial Direct Current StimulationDevice
Sham Transcranial Direct Current Stimulation
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Not described Receives: Device: Transcranial Direct Current Stimulation |
| Sham | Sham comparator | Not described Receives: Device: Sham Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in brain functional connectivity
Functional MRI will measure changes in brain function during tDCS. Specifically, the investigators will measure change in functional connectivity of prefrontal cortex (% change in Fisher's z).
Measured: Acute/immediate
Secondary outcomes (2)
Changes in depressive symptoms (Hamilton)
Symptoms of depression will be measured before and after 5 sessions of tDCS using Hamilton Depression Rating Scale (HDRS 17-item). Change HDRS score will be used as a secondary outcome measure. Score range is 0-53, where low scores indicate low symptoms.
Measured: 1 week, 2 weeks, 1 month
Changes in depressive symptoms (Beck)
Symptoms of depression will be measured before and after 5 sessions of tDCS using Beck Depression Inventory (BDI). Change BDI score will be used as a secondary outcome measure. Score range is 0-62, where low scores indicate low symptoms.
Measured: 1 week, 2 weeks, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start1 Jul 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Leaver, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05090397
- Sponsor's protocol ID
- STU00213826
- Status last verified
- Aug 2026
- First submitted
- 8 Oct 2021
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applied Strategies for MRI-Guided High-Definition tDCS for Major Depression
- ClinicalTrials.gov ID
- NCT05090397
- Acronym / sponsor ID
- STU00213826
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 22 Oct 2021 (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.
The purpose of this research is to understand how a neurostimulation technique, transcranial electrical stimulation (tES), affects brain function in adults with major depression measured with functional magnetic resonance imaging (fMRI). This study targets a specific kind of tES called transcranial direct current stimulation (tDCS), where a mild, constant current is passed between electrodes placed on the scalp.
Detailed description
This is an investigator-initiated MRI research study of a noninvasive neurostimulation technique, transcranial direct current stimulation (tDCS) using focal "high definition" (HD) electrodes positioned using pre-treatment MRI. Primary objective is to measure changes in brain function during MRI-guided HDtDCS with MRI. Secondary objective is to measure changes in depressive symptoms after five consecutive days of MRI-guided tDCS (20 minutes per session).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Transcranial Direct Current Stimulation |
| Sham | Sham comparator | Device: Sham Transcranial Direct Current Stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Ages between 18 and 65
- 2. Race/ethnicity: all races and ethnic groups
- 3. Sex/Gender: all
- 4. Capacity to provide informed consent
- 5. Diagnosis of Major Depressive Disorder made by volunteer's physician at least one year prior (confirmed by patient self-report)
Key exclusion criteria (11 listed)
- 1. Ages below 18 (neurobiology is quite different in children vs. adults)
- 2. Ages above 65 (cortical excitability changes with age)
- 3. Active suicidal thoughts, ideation, or behavior with plan within the past month (HDRS-17 item 3 score 3-4)
- 4. Change in antidepressant medication within 6 weeks of study start
- 5. Diagnosis of any medical condition potentially affecting brain function: neuropsychiatric or mental disorders, other mood disorders (bipolar disorder, primary anxiety disorder, PTSD), psychotic states or disorders, developmental disorders, neurological disorders, including mild cognitive impairment, significant head injury, significant history of alcohol/substance abuse or dependence within past 12 months, chronic pain (current, or for more than one year within the past one year), other major medical conditions (e.g., cancer, stroke).
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 StimulationTranscranial Direct Current Stimulation (tDCS) uses a mild electrical current to make small (or subtle) changes to how the brain works (or functions). | Device | Active |
| Sham Transcranial Direct Current StimulationSham Transcranial Direct Current Stimulation | Device | Sham |
Primary outcome
Changes in brain functional connectivity
Time frame: Acute/immediate
Functional MRI will measure changes in brain function during tDCS. Specifically, the investigators will measure change in functional connectivity of prefrontal cortex (% change in Fisher's z).
2 secondary outcomes
Changes in depressive symptoms (Hamilton)
Time frame: 1 week, 2 weeks, 1 month
Changes in depressive symptoms (Beck)
Time frame: 1 week, 2 weeks, 1 month
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 12 Aug 2026.
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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 in people with Depression, run by Northwestern University at 1 site in United States.
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 8 inclusion and 11 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 12 Aug 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 United States. 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?
Changes in brain functional connectivity (time frame: Acute/immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.