CClinicalTrials.gg
CompletedNCT04031547Updated Feb 9, 2023

fMRI Study of tES in Major Depression

An Early Phase 1 interventional study of Transcranial Electrical Stimulation (tES) in Depression, sponsored by Northwestern University. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-09.

Sponsored by Northwestern University · Early Phase 1, Interventional, and Basic science

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Feb 2019, registered Jul 2019).
Phase
Early Phase 1
Study type
Interventional
Enrollment
11
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a functional MRI study that will examine the effects of noninvasive transcranial electrical stimulation (tES) on brain function in individuals with Major Depression.

Read the detailed description

The purpose of this research study is to understand how a kind of brain stimulation, called transcranial electrical stimulation (tES), affects brain function in people with major depression.

tES delivers low electrical current to the head using electrodes applied to the skin, and is described as a "neuromodulation" or "neurostimulation" technique. This study uses a specific kind of tES called "transcranial direct current stimulation", or tDCS, where a constant (unchanging) electrical current is passed between two electrodes on the head.

Neuromodulation methods like tES have shown promise in changing brain function, as well as treating some brain disorders like major depression. Yet, how tES brain function remains unclear. To better understand how tES works, the investigators will use MRI (a type of brain scan) to measure brain function during tES in people with major depression.

02

Conditions studied

03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 11 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Northwestern University is the lead sponsor of 1,396 studies on the registry; 199 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ages between 18 and 55
  • diagnosis of Major Depressive Disorder made by a physician, psychiatrist, or psychologist at least one year prior
  • mild-to-moderate symptoms of depression (Hamilton Depression Rating Scale 17-item, HDRS-17, score 8-23)
  • stable standard or no pharmacological antidepressant regimen (SSRI, SNRI, MAOI, or trycyclic/TCA) with no change in treatment 6 weeks prior to study start

Exclusion criteria

Exclusion Criteria:

  • suicidal thoughts, ideation, or behavior within the past month (HDRS-17 item 3 score greater than 1)
  • greater than moderate symptoms of depression within the past month (HDRS-17 score >23)
  • change in antidepressant medication within 6 weeks of study start
  • diagnosis of any medical condition potentially affecting brain function, including neuropsychiatric or mental disorders, other mood disorders (bipolar disorder, anxiety, PTSD), psychotic states or disorders, developmental disorders, neurological disorders, including mild cognitive impairment, significant head injury, significant history of alcohol/substance abuse or dependence
  • MRI contraindications: metal or other implants that are not MR-safe, claustrophobia, pregnancy or suspected pregnancy
  • tES contraindications: skin conditions or injuries on the scalp, hair extensions, wigs, braids, etc. that cannot be removed prior to the study, metal implants or pacemakers
  • other major medical conditions (e.g., cancer, stroke)
  • current medication use potentially affecting brain function, including decongestants, antihistamines, benzodiazepines or other anticonvulsants, anti-psychotics, or antidepressants
  • prisoners will not participate in this study
05

Study design

Phase
Early Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
11 participants (actual)

Study arms

  • Active comparator
    Active tES-fMRI

    Device: Transcranial Electrical Stimulation (tES)

  • Sham comparator
    Inactive/Sham tES-fMRI

    Device: Transcranial Electrical Stimulation (tES)

Interventions

  • DeviceTranscranial Electrical Stimulation (tES)

    In tES, a mild electrical current is passed between two or more electrodes placed on the scalp.

    Also known as: Transcranial Direct Current Stimulation (tDCS)

06

What researchers measure

Primary outcomes

  1. Changes in brain function measured with blood-oxygenation-level-dependent (BOLD) functional MRI

    Blood-oxygenation-level-dependent functional MRI will be used to measure changes in the temporal coherence (functional connectivity) amongst brain regions before, during, and after tES.

    Time frame: 5 minutes before, 5 minutes during, and 5 minutes after tES

07

Study locations

1 site
  • Center for Translational Imaging at Northwestern University
    Chicago, Illinois 60611, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04031547
Lead sponsor
Northwestern University
Collaborators
Brain & Behavior Research Foundation
Responsible party
Amber Leaver (Research Assistant Professor, Northwestern University) — Principal investigator
First posted
Jul 24, 2019
Start date
Feb 1, 2019
Primary completion
Nov 30, 2022
Completion
Nov 30, 2022
Last update
Feb 9, 2023

Study contacts

Amber Leaver, PhD
principal investigator · Northwestern University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion