fMRI Study of tES in Major Depression

Depression Clinical Trial

Official title:

Functional MRI Study of Transcranial Electrical Stimulation in Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04031547
• Other study ID #: STU00207022
• Status: Completed
• Phase: Early Phase 1
• Start date: February 1, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: February 2023
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Transcranial Electrical Stimulation (tES)
In tES, a mild electrical current is passed between two or more electrodes placed on the scalp.

Locations

Country	Name	City	State
United States	Center for Translational Imaging at Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Brain & Behavior Research Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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