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Treatment Resistant DepressionNCT06236711

Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD)

A study testing tDCS in people with Treatment Resistant Depression, run by Mayo Clinic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation (tDCS) in hospitalized adult patients with Treatment Resistant Depression (TRD), assess for any preliminary effect on depressive and cognitive symptoms, and explore the utility of biomarkers to assess… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Treatment Resistant Depression
What is being tested?
tDCS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
20 Mar 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 years and older
  • Clinical diagnosis of treatment-resistant depression (defined as depression that does not remit following two or more treatment attempts of an adequate dose and duration of a minimum duration of 4 weeks)
  • Hospitalized in psychiatric units
  • Voluntary admission status
  • Moderate or severe depression, defined by PHQ-9 ≥ 15
  • Ability to provide informed consent
  • Ability to adhere to protocol

Who cannot join

  • Bipolar disorder
  • Active primary psychotic or substance use disorders (except nicotine dependence) within the past year
  • Any active neurological condition (including seizure disorder, traumatic brain injury, stroke)
  • Contraindications to tDCS (including pacemaker, metallic implants in the head or neck [except orthodontic hardware], skin disease causing irritation)
  • Current pregnancy or positive urine pregnancy test (clinical)
  • Any neuromodulation therapy (including ECT, rTMS, DBS, VNS, TES) within the last 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Feasibility Study of Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD) in Hospitalized Patients

The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation (tDCS) in hospitalized adult patients with Treatment Resistant Depression (TRD), assess for any preliminary effect on depressive and cognitive symptoms, and explore the utility of biomarkers to assess response to tDCS.

Read the detailed description

In this feasibility study the researchers propose to conduct a 5-day tDCS treatment protocol in hospitalized adult patients with TRD, with each treatment session lasting for 30 minutes, delivered twice daily, for a total of 10 stimulations over 5 days. Before and after the 5-day tDCS treatment protocol, assessments will include Montgomery-Asberg Depression Rating Scale (MADRS) to measure depressive symptoms, Snaith-Hamilton Pleasure Scale (SHAPS) to measure anhedonia, Stroop Test to measure memory and executive function, Revised Hopkins Verbal Learning Test (HVLT-R) to test verbal learning and memory, and Digital Symbol Coding Test (DSCT) to measure working memory. Electroencephalography (EEG) for objective electrophysiologic data will also be collected before and after tDCS. A wireless EEG unit (CGX, Cognionic, Inc.) will be used to collect EEG and peak alpha frequency (PAF) as potential target engagement marker for tDCS. The PAF measures the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance. Other potential predictors of treatment response measures collected at baseline include Adverse Childhood Experiences (ACE), premorbid intelligence quotient (pIQ), Wide Range Achievement Reading Test (WRART), and Socioeconomic Status (SES).

Being tested
tDCS
Medical subject headings
Depressive Disorder, Treatment-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCSDevice

    tDCS is a form of noninvasive transcranial stimulation of the brain by delivering low-intensity electrical current to the scalp through two electrodes. The Soterix Medical 1×1 Low Intensity Transcranial DC Stimulator Model 1300A (Soterix Medical, Inc., New York, NY, USA) device will be used in the study. The tDCS device is comprised of a small battery-operated control box that delivers the current through electrodes placed on the scalp, held in place by elastic bands or head straps and worn over the forehead like a headband.

Study groups in NCT06236711
Study groupRoleWhat they receive
tDCS interventional armExperimentalParticipants will receive a 30-minute tDCS treatments at 2 mA twice daily over the course of 5 days.
Receives: Device: tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility outcome

    Defined as 70% of eligible patients choosing to enroll in the study. Other feasibility parameters will include willingness of clinicians to refer and help recruit patients, number of eligible participants, willingness of participants to enroll, retention of patients, and completeness of data collection.

    Measured: through study completion, an average of 2 weeks

  2. Acceptability outcome

    Defined as 80% of study participants completing 80% of the 10-session tDCS treatment protocol. Investigators will also ask participants about their satisfaction, perceptions, and experiences with the tDCS treatments. Other acceptability parameters will include rates of adherence to tDCS protocol, dropout rates and reasons for non-completion.

    Measured: through study completion, an average of 2 weeks

  3. Tolerability outcome

    Defined as an overall tolerability rating of "very tolerable." This will be a self-report based on a global question "Considering all aspects of your experience, how would you rate the overall tolerability of the tDCS intervention?" The response options are: very tolerable, somewhat tolerable, neutral, somewhat intolerable, and very intolerable. Other tolerability parameters will include the tDCS adverse effects questionnaire.

    Measured: through study completion, an average of 2 weeks

Secondary outcomes (6)

  1. Change in Montgomery-Asberg Depression Rating Scale (MADRS)

    Measure of depressive symptoms. Response is defined by a 50% or more reduction in MADRS score. The MADRS has 10-items which are based on mood symptoms. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).

    Measured: baseline, 2 weeks

  2. Change in Snaith-Hamilton Pleasure Scale (SHAPS)

    Measure of anhedonia. The SHAPS has 14-items which are based on pleasure symptoms. Each item is scored 1 (definitely agree) to 4 (definitely disagree) with overall score ranges from 14 (experience high pleasure) to 56 (experience low pleasure)

    Measured: baseline, 2 weeks

  3. Change in Stroop Test

    Measure of measure memory and executive function. Reaction time (in seconds) in the different conditions of the task (reading the non-conflicting condition, reading the conflicting condition)

    Measured: baseline, 2 weeks

  4. Change in Revised Hopkins Verbal Learning Test (HVLT-R)

    Measure of verbal learning and memory. The HVLT-R has 12-items which are based on memory score. Total recall score (range from 0 to 36). The higher the score indicates better short-term memory, lowers scores indicates worse short-term memory.

    Measured: baseline, 2 weeks

  5. Change in Digital Symbol Coding Test (DSCT)

    Measure of working memory. The DSST involves a key consisting of the numbers 1-9, each paired with a unique, easy to draw symbol. Below the key are a series of numbers that 1-9 in random order and repeated several times, that are to be filled in the corresponding symbol for each number. One point is given for each correct response. Total scores range from 0-9, lower scores indicate worse memory; higher scores indicate better memory.

    Measured: baseline, 2 weeks

  6. Change in Peak alpha frequency (PAF)

    EEG measure of the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance.

    Measured: baseline, 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2024
  2. Study start20 Mar 2025
  3. Primary completion15 Oct 2025
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Open Label
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06236711
Sponsor's protocol ID
23-003274
Status last verified
Sep 2026
First submitted
11 Jan 2024
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Li JW, Ren C, Pazdernik VK, Kung S, Basso MR, Croarkin PE, Aaron B, Anderson AM, Caves CA, Hemm MN, Holland AL, Hoth CR, Jazdzewski EA, Kabristante E, Kandimalla M, Mickle CB, Min HK, Ozger C, Parsons JM, Sheldon RL, Skime MK, St Louis EK, Varatharajah Y, Wagh N, Welker KM, Williams SM, Worrell GA, Lapid MI. Transcranial direct current simulation as an adjunctive treatment for treatment-resistant depression in hospitalized patients: A feasibility study protocol. PLoS One. 2025 Jun 10;20(6):e0324808. doi: 10.1371/journal.pone.0324808. eCollection 2025.

    PubMed 40493630

Questions about this trial

What is this clinical trial studying?

A study testing tDCS in people with Treatment Resistant Depression, run by Mayo Clinic 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 7 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 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. 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?

This study is still under way. Results are not available in the source record yet.

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?

Feasibility outcome (time frame: through study completion, an average of 2 weeks). 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 NCT06236711, 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 Sep 2026.

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