CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 72 enrolled
Drug / intervention
Active - HD tDCS +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04507243
NCT04507243N/ACompleted

Imaging-guided tDCS Therapy in Major Depression

University of California, Los Angeles·interventional·Posted Aug 11, 2020·Updated Apr 30, 2024

In Brief

A clinical study evaluating Active - HD tDCS and Sham - HD tDCS for Major Depressive Disorder. Completed, enrolled 72 participants across 1 site.

Detailed Summary

Noninvasive transcranial direct current stimulation (tDCS) is a low-intensity neuromodulation technique of minimal risk that has been used as an experimental procedure for reducing depressive symptoms and symptoms of other brain disorders. Though tDCS applied to prefrontal brain areas is shown to reduce symptoms in some people with major depressive disorder (MDD), the extent of antidepressant response often differs. Methods that map current flow directly in the brain while a person is receiving tDCS and that determine how functional neuroimaging signal changes after a series of tDCS sessions may help us understand how tDCS works, how it can be optimized, and if it can be used as an effective antidepressant. Investigators will address these questions in a two-part randomized double blind exploratory clinical trial. For this part of the study, investigators will determine relationships between target engagement and clinical outcomes (mood) and functional sub-constructs of cognitive control and emotion negativity bias, and whether imaging markers at baseline predict changes in antidepressant response. One hundred people with depression (50 in each group) will be randomized to receive either HD-tDCS or sham-tDCS for a total of 12 sessions each lasting 20 minutes occurring on consecutive weekdays. At the first and last session, subjects will receive 20-30 minutes of active or sham HD-tDCS in the MRI scanner, which will allow investigators to map tDCS currents, and track changes in regional cerebral blood flow (rCBF) pre-to- post treatment using completely non-invasive methods. At the first and last session and mid-way through the trial, participants will also complete a series of clinical ratings and neurocognitive tests.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 11, 2020
Enrollment StartDec 1, 2020
Primary CompletionMar 7, 2024
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 5.9 years ago

Interventions

Active - HD tDCSdevice

Non-invasive neuromodulation using HD electrodes placed on the scalp to deliver a constant, low current at 2 mA.

Sham - HD tDCSdevice

Sham neuromodulation using HD electrodes placed on the scalp to deliver a low current ramped up/down for 20 sec.