N/A
N=21
A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression
Depression
Bottom Line
View on ClinicalTrials.gov: NCT05188248 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Beck Depression Inventory (BDI-II) Score — 21.29 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Transcranial direct current stimulation (tDCS) (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Beck Depression Inventory (BDI-II) Score |
21.29 | — |
| PRIMARY Analog Mood Scale (AMS) Anxiety Score |
7.95 | — |
| PRIMARY Analog Mood Scale (AMS) Sad Score |
7.19 | — |
| PRIMARY Analog Mood Scale (AMS) Happy Score |
11.67 | — |
| PRIMARY Change in Analog Mood Scale (AMS) Anxiety Score |
2.76 | — |
| PRIMARY Change in Analog Mood Scale (AMS) Sad Score |
2.62 | — |
| PRIMARY Change in Normalized Response Time |
-0.39 | — |
Summary
Depression and other psychiatric conditions are marked by exaggerated, preferential processing (or attention bias) of negative information relative to neutral or positive information. This depression-related attention bias can be measured using the Dot Probe task and Visual Search, that allow assessment of the degree to which one shows bias toward negative information in the presence of neutral or positive information. A clinically effective treatment for depression is noninvasive brain stimulation with transcranial direct current stimulation (tDCS), targeting the dorsolateral prefrontal cortex (DLPFC), delivered in repeated sessions across a period of time. The study will test the effect of a single session of DLPFC tDCS on attention bias in patients with mild to moderate depression.
Eligibility Criteria
Inclusion Criteria
- Aged 18-45
- Female
- Mild to moderate depression (determined by BDI-II scores of 14-19 and 20-28, respectively)
- If taking antidepressants, medication must be stable ≥ 30 days prior to screening
Exclusion Criteria
- Wide-Range Achievement Test-Fourth Edition (WRAT-4) Reading Subtest standard score <85 (to ensure understanding of test procedures)
- Insufficient visual and motor ability to operate the intervention and assessments as judged by treating neurologist or study staff
- Primary psychiatric disorder other than depression (based on MINI)
- Primary neurologic condition that would prevent ability to participate (as determined by study clinician).
- History of head trauma in the last year
- Medical device implants in the head or neck
- History or current uncontrolled seizure disorder
- Current substance abuse disorder
- . Pregnant or lactating women
- Skin disorder/sensitive skin near stimulation locations
Data sourced from ClinicalTrials.gov (NCT05188248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.