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fMRI Study of tES in Major Depression

Functional MRI Study of Transcranial Electrical Stimulation in Major Depression

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04031547
Enrollment
11
Registered
2019-07-24
Start date
2019-02-01
Completion date
2022-11-30
Last updated
2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Brief 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.

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.

Interventions

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

Sponsors

Brain & Behavior Research Foundation
CollaboratorOTHER
Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Changes in brain function measured with blood-oxygenation-level-dependent (BOLD) functional MRI5 minutes before, 5 minutes during, and 5 minutes after tESBlood-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026