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NCT Number: NCT07657234

tDCS for Late-Life Depression

The purpose of this research study is to determine the effectiveness of Transcranial direct current stimulation (tDCS) therapy in the treatment of participants with Late-life depression (LLD).

The study will evaluate feasibility, safety, and tolerability of high-dose (6mA) bilateral tDCS delivered as three daily sessions, 3 times a week, for 3 weeks in older adults (60 y/o and older) with late-life depression.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location contact

Andre Russowsky Brunoni, MD PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants must meet all of the following criteria:

  • age 60 years or older;
  • diagnosis of unipolar major depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by the Mini International Neuropsychiatric Interview (MINI);
  • score of 17 or higher on the 17-item Hamilton Depression Rating Scale (HDRS-17) at screening;
  • stable antidepressant regimen for at least four weeks prior to enrollment, if applicable;
  • capacity to provide informed consent;
  • Clinical Dementia Rating scale of 0 or 0.5.

Exclusion criteria

Participants meeting any of the following criteria will be excluded:

  • contraindications to tDCS including metallic cranial implants, skin conditions at electrode sites (eczema, open wounds, burns, lesions), or history of adverse reaction to tDCS;
  • contraindications to magnetic resonance imaging (MRI) including pacemaker, cochlear implants, ferromagnetic implants, or claustrophobia;
  • history of seizures or epilepsy;
  • bipolar disorder, psychotic disorders, or severe personality disorder;
  • dementia or MoCA score below 17;
  • substance use disorder within the past six months;
  • neuromodulation treatment including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), tDCS, or vagus nerve stimulation (VNS) within the past six months;
  • active suicidal ideation with plan or intent requiring a higher level of care;
  • concurrent use of medications that substantially lower seizure threshold;
  • pregnancy.

Treatment and study plan

High-intensity (6 mA) transcranial direct current stimulation (tDCS)

Device

High-intensity (6 mA), spaced (three daily sessions, 3 times a week, for 3 weeks) transcranial direct current stimulation (tDCS) in older adults (60 y/o and over) with Late-Life Depression

Primary outcomes

  1. Completion Rate

    Time frame: 6 weeks

    The proportion of enrolled participants who complete at least 7 of 9 treatment days.

  2. Target dose achievement

    Time frame: 6 weeks

    The proportion of participants who reach their calculated target dose without dose-limiting intolerance.

  3. Session completion

    Time frame: 6 weeks

    The proportion of scheduled sessions completed across all participants.

  4. Adverse event profile

    Time frame: 6 weeks

    Including incidence, severity, and time course of adverse events.

Secondary outcomes

  1. Target engagement

    Time frame: 6 weeks

    Resting-state fMRI measures functional connectivity between the DLPFC and subgenual anterior cingulate cortex (sgACC). The DLPFC-sgACC connectivity is a biomarker of depression that predicts treatment response to neuromodulation.

    Target engagement would be a significant change in DLPFC-sgACC connectivity.

  2. Clinical - HDRS-17

    Time frame: 6 weeks

    Clinical outcomes are assessed using the HDRS-17 at baseline, weeks 1-5, and week 6. Response is defined as ≥50% reduction in HDRS-17 from baseline. Remission is defined as HDRS-17 ≤7.

  3. Correlation of Stimulation Dose With Change in HDRS 17 Scores

    Time frame: 6 weeks

    Exploratory dose-response analyses will examine correlations between the device stimulation and the changes in clinical outcomes (HDRS-17).

    This is assessed by correlating achieved baseline E-field (Structural MRI (T1- and T2-weighted) values) and changes in clinical outcomes measured by Hamilton Depression Rating Scale-17 item (HDRS-17). Change in HDRS 17 is defined as the difference between baseline and post-treatment scores at 6 weeks. Correlation analyses (Pearson or Spearman coefficients) are used to quantify the relationship.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research Coordinator

CONTACT

[email protected]

214-645-2991

Sponsors and collaborators

Lead sponsor

Andre Russowsky Brunoni

Other

Registry information

Official study title

High-Dose Spaced Bilateral tDCS for Late-Life Depression: Open-Label Pilot Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 18, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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