fMRI Study of tES in Major Depression

• ClinicalTrials.gov Identifier: NCT04031547
• Recruitment Status: Active, not recruiting
• First Posted: July 24, 2019
• Last Update Posted: February 24, 2021
• Sponsor: Northwestern University
• Collaborator: Brain & Behavior Research Foundation
• Information provided by (Responsible Party): Amber Leaver, Northwestern University

Tracking Information

• First Submitted Date: July 22, 2019
• First Posted Date: July 24, 2019
• Last Update Posted Date: February 24, 2021
• Actual Study Start Date: February 1, 2019
• Estimated Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: fMRI Study of tES in Major Depression
• Official Title: 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: Interventional
• Study Phase: Early Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Basic Science
• Condition: Depression

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: July 23, 2019): 20
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2022
• Estimated Primary Completion Date: July 31, 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04031547
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Amber Leaver, Northwestern University
• Study Sponsor: Northwestern University
• Collaborators: Brain & Behavior Research Foundation

Investigators

• Principal Investigator: Amber Leaver, PhD; Northwestern University

• PRS Account: Northwestern University
• Verification Date: February 2021