Back to resultsA Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS)
Sponsored by
About this trial
This is an interventional treatment trial for 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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Female participants with Depression
Arm Description
Female participants with mild to moderate depression 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.
Outcomes
Primary Outcome Measures
Level of Depression before Transcranial direct current stimulation (tDCS)
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.
Level of Anxiety before Transcranial direct current stimulation (tDCS)
Measured by the Beck Anxiety Inventory (BAI) which is a brief, criteria-referenced assessment for measuring anxiety severity and level. Participants respond to 21 items rated on a scale from 0 to 3. Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety. BAI has been found to discriminate well between anxious and non-anxious diagnostic groups in a variety of clinical populations.
Intensity level of Depressive Symptoms
Measured by the Hamilton Depression Rating Scale (HAM-D) which is a 17-item measure that was designed to assess frequency and intensity of depressive symptoms in patients with Major Depressive Disorder (MDD). This measure contains somatic and suicidal ideation items and has demonstrated reliability, validity, and efficiency in adult populations
Intensity level of Depressive Symptoms using SMDDS
The Symptoms of Major Depressive Disorder Scale (SMDDS) is a brief self reported measure for adults with MDD and measures specific symptom dimensions. The qualitative measure has good psychometric properties including high reliability and validity.
Change in the negative affect after Transcranial direct current stimulation (tDCS)
The Positive and Negative Affect Schedule (PANAS-SF) will be administered before and after the Transcranial direct current stimulation (tDCS) session. This is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect.
Change in the negative mood after Transcranial direct current stimulation (tDCS)
Will be assessed by using the Analog Mood Scale (AMS). This is a brief measure of positive and negative mood consisting of three questions (i.e., "How anxious are you?", "How sad are you?", and "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).
Change in attention bias using the Dot Probe task
The dot-probe task will be used to assess depression-related attention bias before and after tDCS administration.To complete the Dot-Probe task, participants will be shown two emotional images (e.g., sad and neutral pair or happy and neutral pair) simultaneously followed by a target in the location of one of the emotional images. Response latencies to targets replacing either the negative/positive or neutral images will be measured before and after training which will be the primary study outcome.
Change in attention bias using the Visual Search task
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 alongside the Dot Probe task. For this task, mean response time (the time between display onset and button press) to the target stimulus for each stimulus type is measured as the main outcome variable.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05188248
Brief Title
A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression
Official Title
A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
December 15, 2021 (Actual)
Primary Completion Date
December 14, 2022 (Actual)
Study Completion Date
December 14, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Female participants with Depression
Arm Type
Experimental
Arm Description
Female participants with mild to moderate depression 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.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS)
Intervention Description
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 Outcome Measure Information:
Title
Level of Depression before Transcranial direct current stimulation (tDCS)
Description
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.
Time Frame
Study tDCS Administration Visit (Day1)
Title
Level of Anxiety before Transcranial direct current stimulation (tDCS)
Description
Measured by the Beck Anxiety Inventory (BAI) which is a brief, criteria-referenced assessment for measuring anxiety severity and level. Participants respond to 21 items rated on a scale from 0 to 3. Each item is descriptive of subjective, somatic, or panic-related symptoms of anxiety. BAI has been found to discriminate well between anxious and non-anxious diagnostic groups in a variety of clinical populations.
Time Frame
Study tDCS Administration Visit (Day1)
Title
Intensity level of Depressive Symptoms
Description
Measured by the Hamilton Depression Rating Scale (HAM-D) which is a 17-item measure that was designed to assess frequency and intensity of depressive symptoms in patients with Major Depressive Disorder (MDD). This measure contains somatic and suicidal ideation items and has demonstrated reliability, validity, and efficiency in adult populations
Time Frame
Study tDCS Administration Visit (Day1)
Title
Intensity level of Depressive Symptoms using SMDDS
Description
The Symptoms of Major Depressive Disorder Scale (SMDDS) is a brief self reported measure for adults with MDD and measures specific symptom dimensions. The qualitative measure has good psychometric properties including high reliability and validity.
Time Frame
Study tDCS Administration Visit (Day1)
Title
Change in the negative affect after Transcranial direct current stimulation (tDCS)
Description
The Positive and Negative Affect Schedule (PANAS-SF) will be administered before and after the Transcranial direct current stimulation (tDCS) session. This is a self-report questionnaire that consists of two 10-item scales (20 items total) to measure both positive and negative affect.
Time Frame
Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Title
Change in the negative mood after Transcranial direct current stimulation (tDCS)
Description
Will be assessed by using the Analog Mood Scale (AMS). This is a brief measure of positive and negative mood consisting of three questions (i.e., "How anxious are you?", "How sad are you?", and "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).
Time Frame
Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Title
Change in attention bias using the Dot Probe task
Description
The dot-probe task will be used to assess depression-related attention bias before and after tDCS administration.To complete the Dot-Probe task, participants will be shown two emotional images (e.g., sad and neutral pair or happy and neutral pair) simultaneously followed by a target in the location of one of the emotional images. Response latencies to targets replacing either the negative/positive or neutral images will be measured before and after training which will be the primary study outcome.
Time Frame
Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
Title
Change in attention bias using the Visual Search task
Description
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 alongside the Dot Probe task. For this task, mean response time (the time between display onset and button press) to the target stimulus for each stimulus type is measured as the main outcome variable.
Time Frame
Pre-tDCS Administration Time (1 hour) and Post-tDCS Administration Time (1 hour)
10. Eligibility
Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Charvet, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
100176
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to leigh.charvet@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
A Pilot Study of the Immediate Effects of DLPFC tDCS on Attention Bias in Depression
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