fMRI Study of tES in Major Depression
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ClinicalTrials.gov Identifier: NCT04031547 |
Recruitment Status :
Active, not recruiting
First Posted : July 24, 2019
Last Update Posted : February 24, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | July 22, 2019 | ||||
First Posted Date ICMJE | July 24, 2019 | ||||
Last Update Posted Date | February 24, 2021 | ||||
Actual Study Start Date ICMJE | February 1, 2019 | ||||
Estimated Primary Completion Date | July 31, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
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. |
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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 |
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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)
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE |
20 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | July 31, 2022 | ||||
Estimated Primary Completion Date | July 31, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
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 |
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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 |
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PRS Account | Northwestern University | ||||
Verification Date | February 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |