tDCS for Late-Life Depression

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Late Life Depression (LLD)
• Intervention / Treatment: Device: High-intensity (6 mA) transcranial direct current stimulation (tDCS)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clinical Research Coordinator; Phone Number: 214-645-2991; Email: alexus.washington@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
      • Principal Investigator: Andre Russowsky Brunoni, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Participants must meet all of the following criteria:

1. age 60 years or older;
2. 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);
3. score of 17 or higher on the 17-item Hamilton Depression Rating Scale (HDRS-17) at screening;
4. stable antidepressant regimen for at least four weeks prior to enrollment, if applicable;
5. capacity to provide informed consent;
6. Clinical Dementia Rating scale of 0 or 0.5.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS in older adults with LLD	Device: High-intensity (6 mA) transcranial direct current stimulation (tDCS); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Completion Rate	The proportion of enrolled participants who complete at least 7 of 9 treatment days.	6 weeks
Target dose achievement	The proportion of participants who reach their calculated target dose without dose-limiting intolerance.	6 weeks
Session completion	The proportion of scheduled sessions completed across all participants.	6 weeks
Adverse event profile	Including incidence, severity, and time course of adverse events.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target engagement	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.	6 weeks
Clinical - HDRS-17	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.	6 weeks
Correlation of Stimulation Dose With Change in HDRS 17 Scores	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.	6 weeks

Collaborators and Investigators

• Sponsor: Andre Russowsky Brunoni
• Investigators: Principal Investigator: Andre Russowsky Brunoni, MD PhD, University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: June 6, 2026
• First Submitted That Met QC Criteria: June 12, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 12, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Behavioral Disciplines and Activities; Electric Stimulation Therapy; Convulsive Therapy; Psychiatric Somatic Therapies; Electroshock; Psychological Techniques; Transcranial Direct Current Stimulation
• Other Study ID Numbers: STU20260143

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No