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Cognitive Training + tDCS for Depression

N/A
Recruiting
Led By Sarah M. Szymkowicz, PhD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Depression severity of 15+ on the MADRS
Age 60+ years
Must not have
Neurological disorders (e.g., dementia, stroke, seizures, traumatic brain injury, Parkinson's disease)
Currently taking medications that would significantly interact with tDCS effects (such as sodium channel blockers or anticonvulsants)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to post-intervention (4-6 weeks)
Awards & highlights
No Placebo-Only Group

Summary

This trial will investigate whether tDCS, a noninvasive brain stimulation technique, can enhance the effects of cognitive training in older adults with depression.

Who is the study for?
This trial is for adults aged 60 and over who have been diagnosed with Major Depressive Disorder, as per DSM-5 criteria. They should be experiencing cognitive complaints and a depression severity of 15+ on the MADRS scale. Participants must speak English fluently and either be on a stable antidepressant regimen for at least six weeks or not taking any antidepressants.
What is being tested?
The study examines if transcranial direct current stimulation (tDCS), which uses mild electrical currents applied to the head, can improve cognitive function when combined with cognitive training in older adults suffering from depression.
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode site, itching, tingling, headache, fatigue, and in rare cases mood changes. Sham stimulation is used as a control and typically has no active side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My depression is severe, scoring 15 or more on a scale.
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I am 60 years old or older.
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I have been diagnosed with Major Depressive Disorder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a neurological disorder such as dementia, stroke, or Parkinson's.
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I am not on medication that affects brain stimulation treatments.
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I do not have disabilities that affect my ability to complete health assessments.
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My memory and thinking test score is below 23.
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I haven't had ECT or TMS in the last 2 months.
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I do not have any urgent medical conditions needing immediate treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to post-intervention (4-6 weeks)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to post-intervention (4-6 weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in NIH Examiner scores
Secondary study objectives
Change in Montgomery Asberg Depression Rating Scale (MADRS) scores)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cognitive Training + Sham StimulationExperimental Treatment2 Interventions
This arm receives cognitive training combined with sham tDCS.
Group II: Cognitive Training + Active StimulationExperimental Treatment2 Interventions
This arm receives cognitive training combined with active tDCS.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Training
2008
Completed Phase 3
~4100
tDCS (sham stimulation)
2017
N/A
~380
tDCS (active stimulation)
2017
N/A
~380

Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
903 Previous Clinical Trials
938,556 Total Patients Enrolled
17 Trials studying Depression
2,379 Patients Enrolled for Depression
American Academy of NeurologyOTHER
11 Previous Clinical Trials
352 Total Patients Enrolled
1 Trials studying Depression
Sarah M. Szymkowicz, PhDPrincipal InvestigatorVanderbilt University Medical Center

Media Library

Cognitive Training Clinical Trial Eligibility Overview. Trial Name: NCT05400512 — N/A
Depression Research Study Groups: Cognitive Training + Sham Stimulation, Cognitive Training + Active Stimulation
Depression Clinical Trial 2023: Cognitive Training Highlights & Side Effects. Trial Name: NCT05400512 — N/A
Cognitive Training 2023 Treatment Timeline for Medical Study. Trial Name: NCT05400512 — N/A
Depression Patient Testimony for trial: Trial Name: NCT05400512 — N/A
~4 spots leftby Jun 2025
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