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fMRI Study of tES in Major Depression

Sponsor
Northwestern University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04031547
Collaborator
Brain & Behavior Research Foundation (Other)
20
Enrollment
1
Location
2
Arms
40.9
Anticipated Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Electrical Stimulation (tES)
 Early Phase 1

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Functional MRI Study of Transcranial Electrical Stimulation in Major Depression
Actual Study Start Date :
Feb 1, 2019
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active tES-fMRI

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

    		•
    Sham Comparator: Inactive/Sham tES-fMRI

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

    		•

    Outcome Measures

    Primary Outcome Measures

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    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:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Center for Translational Imaging at Northwestern University Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Northwestern University
    • Brain & Behavior Research Foundation

    Investigators

    • Principal Investigator: Amber Leaver, PhD, Northwestern University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Amber Leaver, Research Assistant Professor, Northwestern University
    ClinicalTrials.gov Identifier:
    NCT04031547
    Other Study ID Numbers:
    • STU00207022
    First Posted:
    Jul 24, 2019
    Last Update Posted:
    Aug 16, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder

    Study Results

    No Results Posted as of Aug 16, 2021