Recruiting
Phase 1
Phase 2

tDCS

Sponsor:

Andre Russowsky Brunoni

Code:

NCT07657234

Conditions

Late Life Depression (LLD)

Depression - Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT07657234

Start date

Oct, 2026

Status verified date

Sep, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Oct, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

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. depressive disorder due to a medical condition;
4. psychotic depression;
5. history of seizures or epilepsy;
6. bipolar disorder;
7. psychotic disorders;
8. severe personality disorder;
9. active substance use disorder within the past six months or history of substance induced mood or psychotic disorder;
10. neuromodulation treatment including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), tDCS, or vagus nerve stimulation (VNS) within the past six months;
11. active suicidal ideation with plan or intent requiring a higher level of care;
12. concurrent use of medications that substantially lower seizure threshold;
13. pregnancy;
14. a clinically established diagnosis of dementia as reported in the participant's health record or scoring 1 or above on CDR;
15. medically unstable in the clinical opinion of the principal investigators.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tDCS in older adults with LLD

Interventions

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

Primary outcome measure

  • Treatment Tolerability [ Time Frame: 6 weeks ]
  • Treatment Feasibility [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Principal Investigator:

Andre Russowsky Brunoni, MD PhD

More Information

Sponsor

Andre Russowsky Brunoni

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • brain stimulation
  • tDCS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Andre Russowsky Brunoni on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.