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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05188248
• Other study ID #: 21-01461
• Status: Completed
• Phase: N/A
• Start date: December 15, 2021
• Est. completion date: December 14, 2022

Study information

• Verified date: December 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 14, 2022
• Est. primary completion date: December 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Transcranial direct current stimulation (tDCS)
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)

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Beck Depression Inventory (BDI-II) Score	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.	Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
Primary	Analog Mood Scale (AMS) Anxiety Score	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.	Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
Primary	Analog Mood Scale (AMS) Sad Score	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.	Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
Primary	Analog Mood Scale (AMS) Happy Score	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.	Study tDCS Administration Visit (Day1), Pre-tDCS Administration Time (1 hour)
Primary	Change in Analog Mood Scale (AMS) Anxiety Score	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.	Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Primary	Change in Analog Mood Scale (AMS) Sad Score	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.	Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Primary	Change in Normalized Response Time	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.	Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)