tDCS for Late-Life Depression

NCT07657234 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: STU20260143
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Late Life Depression (LLD); Depression - Major Depressive Disorder

Keywords

brain stimulation; tDCS

Outcome Measures

Primary Outcomes (2)

• Treatment Tolerability

  The proportion of participants who tolerate 6mA across the entire treatment course without dose-limiting adverse events.

  6 weeks

• Treatment Feasibility

  Completion Rate: The proportion of enrolled participants who complete 21 of 27 treatments over a 3-week period.

  6 weeks

Secondary Outcomes (2)

• Mean change in IDS-C score

  6 weeks

• Depression Response Rate

  6 weeks

Other Outcomes (1)

• Target engagement

  6 weeks

Study Arms (1)

tDCS in older adults with LLD

EXPERIMENTAL

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

Interventions

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

tDCS in older adults with LLD

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 Structured Clinical Interview for DSM-5 (SCID-5);
• score of 16 or higher on the Quick Inventory of Depressive Symptomology-Clinician Rated (QIDS-C) at screening;
• stable antidepressant regimen for at least four weeks prior to enrollment, if applicable;
• willingness and capacity to provide informed consent;
• Clinical Dementia Rating scale of 0 or 0.5.
• availability of an informant who has sufficient knowledge of the participant's daily functioning as ascertained by the study team.

You may not qualify if:

• 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;
• depressive disorder due to a medical condition;
• psychotic depression;
• history of seizures or epilepsy;
• bipolar disorder;
• psychotic disorders;
• severe personality disorder;
• active substance use disorder within the past six months or history of substance induced mood or psychotic disorder;
• 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;
• a clinically established diagnosis of dementia as reported in the participant's health record or scoring 1 or above on CDR;

Sponsors & Collaborators

• Andre Russowsky Brunoni: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Andre Russowsky Brunoni, MD PhD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Research Coordinator

CONTACT

214-645-2991; alexus.washington@utsouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chief of the Division of Interventional Psychiatry Department of Psychiatry UT Southwestern Medical Center Peter O'Donnell Jr. Brain Institute

Model Details: This is a single-arm, open-label pilot study.

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 18, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

US (1)