AgingNCT05400512
Cognitive Enhancement in Depression (The COG-D Study)
A study testing Cognitive Training and tDCS (active stimulation) in people with Aging and Depression, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
This study will investigate whether transcranial direct current stimulation (tDCS) enhances the effects of computerized cognitive training in older adults with recurrent depression (2 or more lifetime episodes; either current or within past 3 years). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Aging, Depression, Cognitive Symptom
- What is being tested?
- Cognitive Training and tDCS (active stimulation)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2023to 18 Aug 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60+ years
- Diagnosis of a current or past (within last 3 years) depressive episode (e.g., Major Depressive Disorder (MDD), Persistent Depressive Disorder (PDD)) using Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
- In total, participants must have 2 or more lifetime depressive episodes to be considered "recurrent"
- Either stable antidepressant regimen for at least 6 weeks or no current antidepressant treatment
- Evidence of subjective cognitive complaints on the Everyday Cognition Scale (ECog)
- English fluency
Who cannot join
- Other Axis I psychiatric conditions via the DSM-5, except for anxiety symptoms occurring in a depressive episode
- Acute suicidality on clinical evaluation
- Acute grief
- History of alcohol use disorder or substance use disorder in last 12 months
- Currently taking medications that would significantly interact with tDCS effects (such as sodium channel blockers or anticonvulsants)
- Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury, Parkinson's disease)
Show all 14Show fewer
- Montreal Cognitive Assessment (MoCA) score < 23
- Primary amnestic cognitive profile (>1.5 standard deviations (SDs) below demographically-adjusted mean on National Alzheimer's Coordinating Center (NACC) memory measures in context of otherwise normal cognitive profile)
- Any physical or intellectual disability affecting ability to complete assessments
- Unstable medical illness needing urgent treatment
- MRI contraindications
- Electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) in last 2 months
- Current involvement in psychotherapy
- Current involvement in other research studies (including but not limited to: neuromodulation [TMS or tDCS] or investigational drug studies)
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Non-invasive Neuromodulation to Enhance Targeted Cognitive Remediation in Older Adults With Depression
This study will investigate whether transcranial direct current stimulation (tDCS) enhances the effects of computerized cognitive training in older adults with recurrent depression (2 or more lifetime episodes; either current or within past 3 years).
Read the detailed description
The purpose of this study is to determine whether the addition of active tDCS to computerized cognitive remediation (nCCR) enhances brain activity and cognitive functions in older adults with recurrent depression to a greater degree than nCCR with sham stimulation. The investigators will randomize 20 elderly depressed outpatients to either double-blinded active or sham bifrontal tDCS plus daily nCCR over 4-weeks. Multimodal MRI (focused on the cognitive control network; CCN) and psychiatric and neuropsychological evaluations will be obtained at baseline and following intervention completion. Long-term CCN cognitive effects will be explored 3-months post-intervention via cognitive assessments.
- Conditions
- Aging, Depression, Cognitive Symptom
- Being tested
- Cognitive Training, tDCS (active stimulation), tDCS (sham stimulation)
- Keywords
- geriatrics, aging, elderly, cognition, memory, depression, tDCS, cognitive training, cognitive remediation
- Medical subject headings
- Depression, Neurobehavioral Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
Computerized cognitive training targeting the underlying cerebral networks associated with depression.
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 group | Role | What they receive |
|---|---|---|
| Cognitive Training + Active Stimulation | Experimental | This arm receives cognitive training combined with active tDCS. Receives: Behavioral: Cognitive Training; Device: tDCS (active stimulation) |
| Cognitive Training + Sham Stimulation | Experimental | This arm receives cognitive training combined with sham tDCS. Receives: Behavioral: Cognitive Training; Device: tDCS (sham stimulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task-based fMRI Activation Within the Cognitive Control Network During the N-back Task
MRI scans were performed at baseline (T1) and after completion of the intervention (4 to 6 weeks later; T2). MRI measured Cognitive Control Network function, operationalized as change in n-back functional MRI response in the anterior cingulate cortex (ACC), dorsolateral prefrontal cortex (DLPFC), and the posterior parietal cortex (PPC) regions of interest. The n-back functional MRI response was calculated as the activation difference (beta values) between 2-back and 0-back conditions of the n-back. Higher scores indicate more activation during the 2-back condition compared to the 0-back condition.
Measured: From baseline (T1) to post-intervention (4-6 weeks; T2)
N-back Behavioral Performance (Accuracy)
Target accuracy data on the n-back were extracted for each n-back condition (2-back and 0-back). Higher scores for the metrics indicated better accuracy.
Measured: From baseline (T1) to post-intervention (4-6 weeks; T2)
N-back Behavioral Performance (Response Time)
Target response time data on the n-back were extracted for each n-back condition (2-back and 0-back). Lower scores indicate faster response times.
Measured: From baseline (T1) to post-intervention (4-6 weeks; T2)
NIH Examiner Scores
Computerized neuropsychological battery to assess range of executive functions. The Executive Composite represents overall executive function performance across multiple neuropsychological measures. Item Response Theory (IRT) Empirical Bayes scoring based on the saved parameters from the 3 factors (Working Memory, Cognitive Control, Fluency) are used to generate scores, which are not a norm-referenced measure and are not adjusted for age. The composite is presented in the original metric used in the IRT algorithm. Scores range from -1.50 to 1.52. Higher scores mean better executive function.
Measured: From baseline (T1) to post-intervention (4-6 weeks; T2)
Secondary outcomes (1)
California Verbal Learning Test, 2nd Edition (CVLT-2) Scores
The California Verbal Learning Test, 2nd edition (CVLT-2) is a standardized measure of verbal learning and memory. Raw scores are obtained and converted to age and sex-adjusted z-scores, with 0 indicating population average. Positive values indicate of better than average learning and memory performances.
Measured: From baseline (T1) to post-intervention (4-6 weeks; T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start8 Feb 2023
- Primary completion18 Aug 2025
- Study completion18 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Neurology
- Responsible party
- Principal investigator, Sarah Szymkowicz, Vanderbilt University Medical Center
- Investigators
- Sarah M. Szymkowicz, PhD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400512
- Sponsor's protocol ID
- 220283
- Status last verified
- Sep 2026
- First submitted
- 27 May 2022
- Last updated
- 2 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Neuromodulation to Enhance Targeted Cognitive Remediation in Older Adults With Depression
- ClinicalTrials.gov ID
- NCT05400512
- Acronym / sponsor ID
- 220283
- Conditions
- Aging, Depression, Cognitive Symptom
- Keywords
- geriatrics, aging, elderly, cognition, memory, depression, tDCS, cognitive training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- American Academy of Neurology
- Study start
- 8 Feb 2023 (actual)
- Primary completion
- 18 Aug 2025 (actual)
- Study completion
- 18 Aug 2025 (actual)
- First posted
- 1 Jun 2022 (actual)
- Results
- Posted 2 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will investigate whether transcranial direct current stimulation (tDCS) enhances the effects of computerized cognitive training in older adults with recurrent depression (2 or more lifetime episodes; either current or within past 3 years).
Detailed description
The purpose of this study is to determine whether the addition of active tDCS to computerized cognitive remediation (nCCR) enhances brain activity and cognitive functions in older adults with recurrent depression to a greater degree than nCCR with sham stimulation. The investigators will randomize 20 elderly depressed outpatients to either double-blinded active or sham bifrontal tDCS plus daily nCCR over 4-weeks. Multimodal MRI (focused on the cognitive control network; CCN) and psychiatric and neuropsychological evaluations will be obtained at baseline and following intervention completion. Long-term CCN cognitive effects will be explored 3-months post-intervention via cognitive assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training + Active Stimulation | Experimental | Behavioral: Cognitive Training, Device: tDCS (active stimulation)This arm receives cognitive training combined with active tDCS. |
| Cognitive Training + Sham Stimulation | Experimental | Behavioral: Cognitive Training, Device: tDCS (sham stimulation)This arm receives cognitive training combined with sham tDCS. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 60+ years
- Diagnosis of a current or past (within last 3 years) depressive episode (e.g., Major Depressive Disorder (MDD), Persistent Depressive Disorder (PDD)) using Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria
- In total, participants must have 2 or more lifetime depressive episodes to be considered "recurrent"
- Either stable antidepressant regimen for at least 6 weeks or no current antidepressant treatment
- Evidence of subjective cognitive complaints on the Everyday Cognition Scale (ECog)
Key exclusion criteria (14 listed)
- Other Axis I psychiatric conditions via the DSM-5, except for anxiety symptoms occurring in a depressive episode
- Acute suicidality on clinical evaluation
- Acute grief
- History of alcohol use disorder or substance use disorder in last 12 months
- Currently taking medications that would significantly interact with tDCS effects (such as sodium channel blockers or anticonvulsants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TrainingComputerized cognitive training targeting the underlying cerebral networks associated with depression. | Behavioural | Cognitive Training + Active Stimulation, Cognitive Training + Sham Stimulation |
| tDCS (active stimulation)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). | Device | Cognitive Training + Active Stimulation |
| tDCS (sham stimulation)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. | Device | Cognitive Training + Sham Stimulation |
Primary outcome
Task-based fMRI Activation Within the Cognitive Control Network During the N-back Task
Time frame: From baseline (T1) to post-intervention (4-6 weeks; T2)
MRI scans were performed at baseline (T1) and after completion of the intervention (4 to 6 weeks later; T2). MRI measured Cognitive Control Network function, operationalized as change in n-back functional MRI response in the anterior cingulate cortex (ACC), dorsolateral prefrontal cortex (DLPFC), and the posterior parietal cortex (PPC) regions of interest. The n-back functional MRI response was calculated as the activation difference (beta values) between 2-back and 0-back conditions of the n-back. Higher scores indicate more activation during the 2-back condition compared to the 0-back condition.
N-back Behavioral Performance (Accuracy)
Time frame: From baseline (T1) to post-intervention (4-6 weeks; T2)
Target accuracy data on the n-back were extracted for each n-back condition (2-back and 0-back). Higher scores for the metrics indicated better accuracy.
N-back Behavioral Performance (Response Time)
Time frame: From baseline (T1) to post-intervention (4-6 weeks; T2)
Target response time data on the n-back were extracted for each n-back condition (2-back and 0-back). Lower scores indicate faster response times.
NIH Examiner Scores
Time frame: From baseline (T1) to post-intervention (4-6 weeks; T2)
Computerized neuropsychological battery to assess range of executive functions. The Executive Composite represents overall executive function performance across multiple neuropsychological measures. Item Response Theory (IRT) Empirical Bayes scoring based on the saved parameters from the 3 factors (Working Memory, Cognitive Control, Fluency) are used to generate scores, which are not a norm-referenced measure and are not adjusted for age. The composite is presented in the original metric used in the IRT algorithm. Scores range from -1.50 to 1.52. Higher scores mean better executive function.
1 secondary outcome
California Verbal Learning Test, 2nd Edition (CVLT-2) Scores
Time frame: From baseline (T1) to post-intervention (4-6 weeks; T2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Aging
Not yet recruiting
Effects of Art-Based Group Reminiscence Therapy on Resilience and Joy of Living in Older Adults
Resilience, Psychological, Joy of Living
Recruiting
Intergenerational Interaction Program for Nursing Home Residents and Nursing Students
Ageism, Loneliness
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
Active, not recruitingObservational study
Healthy Aging in Neighborhoods of Diversity Across the Life Span (HANDLS)
Diabetes, Cerebrovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah M. Szymkowicz, PhD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training and tDCS (active stimulation) in people with Aging and Depression, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task-based fMRI Activation Within the Cognitive Control Network During the N-back Task (time frame: From baseline (T1) to post-intervention (4-6 weeks; T2)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.