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fMRI Study of tES in Major Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04031547
Recruitment Status : Recruiting
First Posted : July 24, 2019
Last Update Posted : July 25, 2019
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Amber Leaver, Northwestern University

Tracking Information
First Submitted Date  ICMJE July 22, 2019
First Posted Date  ICMJE July 24, 2019
Last Update Posted Date July 25, 2019
Actual Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE fMRI Study of tES in Major Depression
Official Title  ICMJE Functional MRI Study of Transcranial Electrical Stimulation in Major Depression
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Condition  ICMJE Depression
Intervention  ICMJE 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)
Study Arms  ICMJE
  • Active Comparator: Active tES-fMRI
    Intervention: Device: Transcranial Electrical Stimulation (tES)
  • Sham Comparator: Inactive/Sham tES-fMRI
    Intervention: Device: Transcranial Electrical Stimulation (tES)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 23, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amber Leaver, PhD 3126942966 inmri@northwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04031547
Other Study ID Numbers  ICMJE STU00207022
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amber Leaver, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Brain & Behavior Research Foundation
Investigators  ICMJE
Principal Investigator: Amber Leaver, PhD Northwestern University
PRS Account Northwestern University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP