Late Life Depression (LLD)
Conditions
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.
Interventions
DEVICEHigh-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
Sponsors
Andre Russowsky Brunoni
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
This is a single-arm, open-label pilot study.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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 Mini International Neuropsychiatric Interview (MINI); 3. score of 17 or higher on the 17-item Hamilton Depression Rating Scale (HDRS-17) at screening; 4. stable antidepressant regimen for at least four weeks prior to enrollment, if applicable; 5. capacity to provide informed consent; 6. Clinical Dementia Rating scale of 0 or 0.5.
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. history of seizures or epilepsy; 4. bipolar disorder, psychotic disorders, or severe personality disorder; 5. dementia or MoCA score below 17; 6. substance use disorder within the past six months; 7. neuromodulation treatment including electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), tDCS, or vagus nerve stimulation (VNS) within the past six months; 8. active suicidal ideation with plan or intent requiring a higher level of care; 9. concurrent use of medications that substantially lower seizure threshold; 10. pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Completion Rate | 6 weeks | The proportion of enrolled participants who complete at least 7 of 9 treatment days. |
| Target dose achievement | 6 weeks | The proportion of participants who reach their calculated target dose without dose-limiting intolerance. |
| Session completion | 6 weeks | The proportion of scheduled sessions completed across all participants. |
| Adverse event profile | 6 weeks | Including incidence, severity, and time course of adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Target engagement | 6 weeks | Resting-state fMRI measures functional connectivity between the DLPFC and subgenual anterior cingulate cortex (sgACC). The DLPFC-sgACC connectivity is a biomarker of depression that predicts treatment response to neuromodulation. Target engagement would be a significant change in DLPFC-sgACC connectivity. |
| Clinical - HDRS-17 | 6 weeks | Clinical outcomes are assessed using the HDRS-17 at baseline, weeks 1-5, and week 6. Response is defined as ≥50% reduction in HDRS-17 from baseline. Remission is defined as HDRS-17 ≤7. |
| Correlation of Stimulation Dose With Change in HDRS 17 Scores | 6 weeks | Exploratory dose-response analyses will examine correlations between the device stimulation and the changes in clinical outcomes (HDRS-17). This is assessed by correlating achieved baseline E-field (Structural MRI (T1- and T2-weighted) values) and changes in clinical outcomes measured by Hamilton Depression Rating Scale-17 item (HDRS-17). Change in HDRS 17 is defined as the difference between baseline and post-treatment scores at 6 weeks. Correlation analyses (Pearson or Spearman coefficients) are used to quantify the relationship. |
Countries
United States
Contacts
CONTACTClinical Research Coordinator
PRINCIPAL_INVESTIGATORAndre Russowsky Brunoni, MD PhD
University of Texas Southwestern Medical Center
Outcome results
None listed