fMRI Study of tES in Major Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Functional MRI Study of Transcranial Electrical Stimulation in Major Depression

Conditions
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Depression

Intervention / Treatment
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* Device: Transcranial Electrical Stimulation (tES)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active tES-fMRI<br> | Device: Transcranial Electrical Stimulation (tES)<br>* In tES, a mild electrical current is passed between two or more electrodes placed on the scalp.<br>* Other names: Transcranial Direct Current Stimulation (tDCS);|
| Sham Comparator: Inactive/Sham tES-fMRI<br> | Device: Transcranial Electrical Stimulation (tES)<br>* In tES, a mild electrical current is passed between two or more electrodes placed on the scalp.<br>* Other names: Transcranial Direct Current Stimulation (tDCS);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 5 minutes before, 5 minutes during, and 5 minutes after tES |