tDCS for Late-Life Depression
High-Dose Spaced Bilateral tDCS for Late-Life Depression: Open-Label Pilot Study
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 3 weeks
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether tDCS, a treatment that uses electrical current to stimulate the brain, helps adults age 60 or older with depression. It also checks whether high-dose treatment (6 mA) is safe, manageable, and practical to give. Treatment includes three sessions a day, on three days a week, for three weeks.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 60 or older.
- A study interview confirms major depression that is not part of bipolar disorder.
- You score 16 or higher on the QIDS-C depression symptom scale at screening.
- If you take antidepressants, your treatment has been stable for at least four weeks before joining.
- You are willing and able to understand the study and agree to join.
- You have a Clinical Dementia Rating (CDR) score of 0 or 0.5.
- Someone who knows enough about your daily activities is available to give information to the study team.
Who can't join
- You cannot safely receive tDCS because of metal implants in your skull, skin problems where the pads go, or a past bad reaction to tDCS.
- You cannot have an MRI scan because of a pacemaker, hearing implant, magnetic metal implant, or fear of enclosed spaces.
- You have depression caused by a medical condition, bipolar disorder, a severe personality disorder, or psychosis—with or without depression. Psychosis means losing touch with reality.
- You have a history of seizures or epilepsy, or take medicines that greatly raise seizure risk.
- You have had an active drug or alcohol use disorder in the past six months, or a past mood disorder or psychosis caused by substance use.
- You have received brain or nerve stimulation treatment in the past six months, including ECT, TMS, tDCS, or VNS.
- You have thoughts of suicide with a plan or intent that require more intensive care.
- You are pregnant, have diagnosed dementia or a CDR score of 1 or higher, or the study doctors consider your health medically unstable.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (1)
TX
- University of Texas Southwestern Medical Center · Dallas, TX 75390Andre Russowsky Brunoni, MD PhD · Principal investigatorMore trials in Dallas