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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS in older adults with LLD | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-intensity (6 mA) transcranial direct current stimulation (tDCS) | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Completion Rate | The proportion of enrolled participants who complete at least 7 of 9 treatment days. | 6 weeks |
| Target dose achievement | The proportion of participants who reach their calculated target dose without dose-limiting intolerance. | 6 weeks |
| Session completion | The proportion of scheduled sessions completed across all participants. | 6 weeks |
| Adverse event profile | Including incidence, severity, and time course of adverse events. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 weeks |
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Inclusion Criteria:
Participants must meet all of the following criteria:
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Coordinator | Contact | 214-645-2991 | alexus.washington@utsouthwestern.edu |
| Name | Affiliation | Role |
|---|---|---|
| Andre Russowsky Brunoni, MD PhD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 4, 2026 | Jun 6, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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This is a single-arm, open-label pilot study.
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| 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. |
| 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. | 6 weeks |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |