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

NCT05188248 | Completed Results DMC FDA Device

• 1 other identifier: 21-01461
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (7)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Female participants with Depression

EXPERIMENTAL

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.

Device: Transcranial direct current stimulation (tDCS)

Interventions

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)

Female participants with Depression

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 100176, United States

Location

Related Publications (1)

• Pilloni G, Cho H, Tian TE, Beringer J, Bikson M, Charvet L. Immediate and Differential Response to Emotional Stimuli Associated With Transcranial Direct Current Stimulation for Depression: A Visual-Search Task Pilot Study. Neuromodulation. 2024 Jun;27(4):759-765. doi: 10.1016/j.neurom.2023.07.006. Epub 2023 Aug 20.

  PMID: 37598327 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Matthew Lustberg
• Organization: NYU Langone

matthew.lustberg@nyulangone.org

929-455-5090

Study Officials

• Leigh Charvet, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 12, 2022
• Study Start: December 15, 2021
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: January 10, 2024
• Results First Posted: January 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• 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.
• 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.

Locations

US (1)