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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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The goal of this clinical trial is to learn if a combination of non-drug treatments works to benefit memory, thinking, and brain functioning in older individuals with recurrent depression. The non-drug approaches the investigators are studying include transcranial direct current stimulation (tDCS) and computerized cognitive training. tDCS uses small currents of electricity on the forehead to potentially stimulate your brain's ability to process and learn. Computerized cognitive training uses tablet games to improve memory and thinking.
In this study, two different cognitive training programs are being investigated, both of which are stimulating and designed to engage brain activity. One that is believed to be a specific treatment for depression, while the other provides extra stimulation for the brain that is non-specific. Two different tDCS parameters - active stimulation and sham (or placebo) stimulation - are also being investigated.
Participants will be randomized to one of three study groups:
The main questions this clinical trial aims to answer are:
Participants will:
The purpose of this study is to determine whether stepwise engagement of the frontal lobe across randomized groups (active tDCS+depression cognitive training > sham tDCS+depression cognitive training > sham tDCS+non-specific cognitive training) will result in progressively greater improvements in executive functions and memory, as well as intrinsic functional connectivity of the Executive Control Network (ECN), in older adults with recurrent depression. The investigators will randomize 69 elderly depressed outpatients into one of three conditions daily over 4-weeks. Psychiatric and neuropsychological evaluations, as well as multimodal neuroimaging (focused on the ECN) will be obtained at baseline and following intervention completion to look at acute and long-term effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Depression Cognitive Training + Active Stimulation | Experimental | This arm receives the depression cognitive training combined with active tDCS. |
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| Depression Cognitive Training + Sham Stimulation | Experimental | This arm receives the depression cognitive training combined with sham tDCS. |
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| Non-Specific Cognitive Training + Sham Stimulation | Experimental | This arm receives the non-specific cognitive training combined with sham tDCS. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depression Cognitive Training | Behavioral | Computerized cognitive training targeting the underlying cerebral networks associated with depression. |
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| Measure | Description | Time Frame |
|---|---|---|
| NIH Examiner | This objective cognitive test battery assesses a range of executive functions (working memory, inhibition, set shifting, fluency, and planning). The investigators will examine intervention-related change its Executive Composite Score (primary outcome), and subcomposite (Cognitive Control, Working Memory, and Fluency; secondary outcomes) scores, where higher scores indicate better performance. | Baseline, Following completion of the 4-week intervention, 3-month Post-Intervention |
| Resting state fMRI functional connectivity | Functional connectivity from resting state fMRI will be processed using the CONN toolbox for connectivity, incorporating the Shaeffer network atlases to improve peer-research supported network usage in addition to the standard CONN atlases. A priori ROI-to-ROI analyses will be used to determine whether average connectivity changes in the Executive Control Network differs by treatment group. Analyses will control for multiple comparisons at false discovery rate (FDR) < 0.05. | Baseline, Following completion of the 4-week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery Asberg Depression Rating Scale | The MADRS is a 10-item clinician-rated measure of depression severity, with higher scores indicating greater symptom severity. We will look at change in depression severity over the course of the intervention by treatment arm in Exploratory Analyses. | Baseline and weekly thereafter, Following completion of the 4-week intervention, 3-Month Post-Intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Szymkowicz, PhD | Contact | 615-875-0032 | sarah.szymkowicz@vumc.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2026 | Mar 23, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D019954 | Neurobehavioral Manifestations |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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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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Triple-blinded
| Non-Specific Cognitive Training | Behavioral | Computerized cognitive training that provides extra stimulation for the brain that is non-specific. |
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| tDCS (active stimulation) | Device | A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0 milliamps (mA) direct current through two bicarbon rubber electrodes encased in saline soaked 5 cm x 7 cm sponges (8 cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (via 10-20 system). |
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| tDCS (sham stimulation) | Device | Sham stimulation will be performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure. |
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |