Cognitive Enhancement in Recurrent Depression (The COG-D-R Study)
Part of paid clinical trials in Nashville, Tennessee.
- Sponsor
- Vanderbilt University Medical Center
- Study ID
- NCT07527273
- Status
- Not Yet Recruiting
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Conditions
- Aging
- Cognitive Symptoms
- Depression
Eligibility Criteria
- Sex
- ALL
- Age
- 60 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Depression Cognitive Training — BEHAVIORALComputerized cognitive training targeting the underlying cerebral networks associated with depression.
- Non-Specific Cognitive Training — BEHAVIORALComputerized cognitive training that provides extra stimulation for the brain that is non-specific.
- tDCS (active stimulation) — DEVICEA 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).
- tDCS (sham stimulation) — DEVICESham 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.
Study Details
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: 1. Depression cognitive training treatment with active brain stimulation 2. Depression cognitive training treatment with sham brain stimulation 3. Non-specific cognitive training treatment with sham brain stimulation The main questions this clinical trial aims to answer are: * Does "depression cognitive training treatment with active brain stimulation" benefit thinking and memory more so than the other treatments? * Does "depression cognitive training treatment with active brain stimulation" benefit brain functioning more so than the other treatments? Participants will: * Complete several baseline and post-intervention visits at the research center for checkups and tests over the course of 3-4 months. * Visit the research center daily for 4 weeks to complete their assigned treatment.
Key Dates
- Start date
- Sep 1, 2026
- Status verified
- May 2026
- Primary completion
- May 30, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 69 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Depression Cognitive Training + Active StimulationThis arm receives the depression cognitive training combined with active tDCS.
- Experimental: Depression Cognitive Training + Sham StimulationThis arm receives the depression cognitive training combined with sham tDCS.
- Experimental: Non-Specific Cognitive Training + Sham StimulationThis arm receives the non-specific cognitive training combined with sham tDCS.
Primary Outcome Measure
NIH Examiner [ Time Frame: Baseline, Following completion of the 4-week intervention, 3-month Post-Intervention ]
Central Contacts
- Sarah Szymkowicz, PhD615-875-0032
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | - |
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