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Completed

NCT Number: NCT04031547

fMRI Study of tES in Major Depression

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Center for Translational Imaging at Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Electrical Stimulation (TES)

Device

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

Other names: Transcranial Direct Current Stimulation (tDCS)

Primary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Brain & Behavior Research Foundation

Registry information

Official study title

Functional MRI Study of Transcranial Electrical Stimulation in Major Depression

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 24, 2019
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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