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

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Depression Cognitive Training — BEHAVIORAL
    Computerized cognitive training targeting the underlying cerebral networks associated with depression.
  • Non-Specific Cognitive Training — BEHAVIORAL
    Computerized cognitive training that provides extra stimulation for the brain that is non-specific.
  • 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).
  • 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.

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 Stimulation
    This arm receives the depression cognitive training combined with active tDCS.
  • Experimental: Depression Cognitive Training + Sham Stimulation
    This arm receives the depression cognitive training combined with sham tDCS.
  • Experimental: Non-Specific Cognitive Training + Sham Stimulation
    This 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

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37212-

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