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fMRI Study of tES in Major Depression

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ClinicalTrials.gov Identifier: NCT04031547
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Amber Leaver, Northwestern University

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
Depression 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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Transcranial Direct Current Stimulation (tDCS)




Primary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04031547


Contacts
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Contact: Amber Leaver, PhD 3126942966 inmri@northwestern.edu

Locations
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United States, Illinois
Center for Translational Imaging at Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Brain & Behavior Research Foundation
Investigators
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Principal Investigator: Amber Leaver, PhD Northwestern University

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Responsible Party: Amber Leaver, Research Assistant Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT04031547     History of Changes
Other Study ID Numbers: STU00207022
First Posted: July 24, 2019    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders