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Taking people in United StatesPhase 1/2

Tests high-dose brain stimulation for depression in older adults

Tests high-intensity electrical brain stimulation in adults aged 60 and older with depression.

Plain-language title generated from the registry record
Registry title: tDCS for Late-Life Depression

Key facts

Where
Dallas, United StatesSee the site
Phase
Phase 1/2

Where in United States

  • University of Texas Southwestern Medical CenterDallas, United StatesTaking people

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Trial details

Who runs it
Andre Russowsky Brunoni
Trial code
NCT07657234
Record updated
25 September 2026
Original description
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).Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: contraindications to magnetic resonance imaging (MRI) including pacemaker, cochlear implants, ferromagnetic implants, or claustrophobia; neuromodulation treatment including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), tDCS, or vagus nerve stimulation (VNS) within the past six months; concurrent use of medications that substantially lower seizure threshold; contraindications to tDCS including metallic cranial implants, skin conditions at electrode sites (eczema, open wounds, burns, lesions), or history of adverse reaction to tDCS; depressive disorder due to a medical condition; 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; a clinically established diagnosis of dementia as reported in the participant's health record or scoring 1 or above on CDR; Participants meeting any of the following criteria will be excluded:; psychotic depression; active suicidal ideation with plan or intent requiring a higher level of care; pregnancy; medically unstable in the clinical opinion of the principal investigators.

ClinicalTrials.gov NCT07657234