Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2023-02-08
2025-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cognitive Training + Active Stimulation
This arm receives cognitive training combined with active tDCS.
Cognitive Training
Computerized cognitive training targeting the underlying cerebral networks associated with depression.
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).
Cognitive Training + Sham Stimulation
This arm receives cognitive training combined with sham tDCS.
Cognitive Training
Computerized cognitive training targeting the underlying cerebral networks associated with depression.
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.
Interventions
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Cognitive Training
Computerized cognitive training targeting the underlying cerebral networks associated with depression.
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).
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
* 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)
60 Years
ALL
No
Sponsors
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American Academy of Neurology
OTHER
Vanderbilt University Medical Center
OTHER
Responsible Party
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Sarah Szymkowicz
Research Instructor
Principal Investigators
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Sarah M. Szymkowicz, PhD
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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220283
Identifier Type: -
Identifier Source: org_study_id
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