NCT07657234 tDCS for Late-Life Depression
| NCT ID | NCT07657234 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Andre Russowsky Brunoni |
| Condition | Late Life Depression (LLD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-10 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2026-10 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Andre Russowsky Brunoni, MD PhD
PRINCIPAL INVESTIGATOR
University of Texas Southwestern Medical Center
Frequently Asked Questions
Who can join the NCT07657234 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Late Life Depression (LLD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07657234 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07657234 currently recruiting?
Yes, NCT07657234 is actively recruiting participants. Contact the research team at alexus.washington@utsouthwestern.edu for enrollment information.
Where is the NCT07657234 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT07657234 clinical trial?
NCT07657234 is sponsored by Andre Russowsky Brunoni. The principal investigator is Andre Russowsky Brunoni, MD PhD at University of Texas Southwestern Medical Center. The trial plans to enroll 20 participants.
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