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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
20
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
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Completion Rate
The proportion of enrolled participants who complete at least 7 of 9 treatment days.
Time frame: 6 weeks
Target dose achievement
The proportion of participants who reach their calculated target dose without dose-limiting intolerance.
Time frame: 6 weeks
Session completion
The proportion of scheduled sessions completed across all participants.
Time frame: 6 weeks
Adverse event profile
Including incidence, severity, and time course of adverse events.
Time frame: 6 weeks
Target engagement
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.
Time frame: 6 weeks
Clinical - HDRS-17
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.
Time frame: 6 weeks
Correlation of Stimulation Dose With Change in HDRS 17 Scores
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.
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Time frame: 6 weeks