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Completed

NCT Number: NCT05188248

A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 100176, United States

About this study

This prospective pilot study will recruit 25 female participants, ages 18-45 (inclusive), with mild to moderate depression (based on BDI-II score range 14-19 for mild and 20-28 for moderate) to determine if a single-session of tDCS can alter negative attention bias. The primary objective is to study if single-session tDCS will affect attention bias in depression and is not meant to treat depression. Subjects may or may not be receiving treatment for mild-moderate depression.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial direct current stimulation (tDCS)

Device

Participants will complete a single 30 minutes tDCS session targeting the left DLPFC while sitting in a comfortable position. At the end of the tDCS session possible side effects experienced during the tDCS session will be recorded along with their intensity (rated using the visual analogue scale, 0-10) and duration. The session can be aborted at any time for any reason if the participant wishes.The MINDD STIM tDCS system is composed of a management component, treatment module, single-use sponge patches and supporting patches, a headband to hold in position the sponge patches, and 2 cables. A trained study technician will program the stimulation device through the management component setting to the following stimulation parameters:Stimulation intensity: 2.0 mA or 1.5 mA; Stimulation duration: 30 minutes;Ramp up duration: 30 seconds (beginning of stimulation);Ramp down duration: 30 seconds (end of stimulation)

Primary outcomes

  1. Beck Depression Inventory (BDI-II) Score

    Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)

    Measured by the Beck Depression Inventory (BDI-II) which is a brief, criteria-referenced assessment for measuring depression severity. The BDI-II consists of 21 items to assess the intensity of depression. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The items are scored as 0, 1, 2, or 3. The score range is 0-63. Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression.

  2. Analog Mood Scale (AMS) Anxiety Score

    Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)

    Analog Mood Scale (AMS) Anxiety is a brief measure of positive and negative mood asking "How anxious are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of anxiety.

  3. Analog Mood Scale (AMS) Sad Score

    Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)

    Analog Mood Scale (AMS) Sad is a brief measure of positive and negative mood asking "How sad are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of sadness.

  4. Analog Mood Scale (AMS) Happy Score

    Time frame: Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)

    Analog Mood Scale (AMS) Happy is a brief measure of positive and negative mood asking "How happy are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of happiness.

  5. Change in Analog Mood Scale (AMS) Anxiety Score

    Time frame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)

    Analog Mood Scale (AMS) Anxiety is a brief measure of positive and negative mood asking "How anxious are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of anxiety. The AMS Anxiety will be administered before and after the Transcranial direct current stimulation (tDCS) session. The change in AMS Anxiety scores (Pre-tDCS Administration Time (1 hour) minus Post-tDCS Administration Time (1 hour)) is reported. A positive value indicates an improvement, less anxiety post-tDCS administration. A negative value indicates increased anxiety post-tDCS administration.

  6. Change in Analog Mood Scale (AMS) Sad Score

    Time frame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)

    Analog Mood Scale (AMS) Sad is a brief measure of positive and negative mood asking "How sad are you?". Participants were told to indicate their present mood by identifying a location on a horizontal line divided into 30 equally distanced segments labeled 1 (not at all) to 30 (very much). Higher scores indicated greater level of sadness. The AMS Sad will be administered before and after the Transcranial direct current stimulation (tDCS) session. The change in AMS Sad scores (Pre-tDCS Administration Time (1 hour) minus Post-tDCS Administration Time (1 hour)) is reported. A positive value indicates an improvement, less sadness post-tDCS administration. A negative value indicates increased sadness post-tDCS administration.

  7. Change in Normalized Response Time

    Time frame: Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)

    The Visual Search task will be administered to further assess attention bias, particularly examining the interference and facilitation effects in attention using emotional stimuli. The task uses emotional faces or words as stimuli, where the participant is instructed to search for the face that does not fit into the search set with respect to gender, where the target and distractors are expressing different or same emotions. This study will use this task as an outcome measure of Attention Bias. For this task, the change in mean response time (the time between display onset and button press) to the target stimulus is measured as the main outcome variable.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 12, 2022
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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