NCT05188248

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2021-12-15
• Primary completion: 2022-12-14
• Completion: 2022-12-14
• First posted: 2022-01-12
• Last updated: 2024-01-10
• Results posted: 2024-01-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study