Back to resultsfMRI Study of tES in Major Depression
Primary Purpose
Depression
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Transcranial Electrical Stimulation (tES)
Sponsored by
About this trial
This is an interventional basic science trial for Depression
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
Sites / Locations
- Center for Translational Imaging at Northwestern University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active tES-fMRI
Inactive/Sham tES-fMRI
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04031547
First Posted
July 22, 2019
Last Updated
February 8, 2023
Sponsor
Northwestern University
Collaborators
Brain & Behavior Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04031547
Brief Title
fMRI Study of tES in Major Depression
Official Title
Functional MRI Study of Transcranial Electrical Stimulation in Major Depression
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
Brain & Behavior Research Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active tES-fMRI
Arm Type
Active Comparator
Arm Title
Inactive/Sham tES-fMRI
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Transcranial Electrical Stimulation (tES)
Other Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Intervention Description
In tES, a mild electrical current is passed between two or more electrodes placed on the scalp.
Primary Outcome Measure Information:
Title
Changes in brain function measured with blood-oxygenation-level-dependent (BOLD) functional MRI
Description
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.
Time Frame
5 minutes before, 5 minutes during, and 5 minutes after tES
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amber Leaver, PhD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Translational Imaging at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
12. IPD Sharing Statement
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fMRI Study of tES in Major Depression
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