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NCT04507243 · ClinicalTrials.gov registry record · NA
Transcranial Direct Current Stimulation (tDCS) Therapy in Major Depression
A NA study of Major Depressive Disorder, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- NA
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT04507243 is a NA study of Major Depressive Disorder that has completed, run by University of California, Los Angeles. The registered enrollment target is 72 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04507243, a NA study of Major Depressive Disorder, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- NA
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
Noninvasive transcranial direct current stimulation (tDCS) is a low-intensity neuromodulation technique of minimal risk that has been used as an experimental procedure for reducing depressive symptoms and symptoms of other brain disorders. Though tDCS applied to prefrontal brain areas is shown to reduce symptoms in some people with major depressive disorder (MDD), the extent of antidepressant response often differs. Methods that map current flow directly in the brain while a person is receiving tDCS and that determine how functional neuroimaging signal changes after a series of tDCS sessions may help us understand how tDCS works, how it can be optimized, and if it can be used as an effective antidepressant. Investigators will address these questions in a two-part randomized double blind exploratory clinical trial. For this part of the study, investigators will determine relationships between target engagement and clinical outcomes (mood) and functional sub-constructs of cognitive control and emotion negativity bias, and whether imaging markers at baseline predict changes in antidepressant response. One hundred people with depression (50 in each group) will be randomized to receive either HD-tDCS or sham-tDCS for a total of 12 sessions each lasting 20 minutes occurring on consecutive weekdays. At the first and last session, subjects will receive 20-30 minutes of active or sham HD-tDCS in the MRI scanner, which will allow investigators to map tDCS currents, and track changes in regional cerebral blood flow (rCBF) pre-to- post treatment using completely non-invasive methods. At the first and last session and mid-way through the trial, participants will also complete a series of clinical ratings and neurocognitive tests.
Conditions Studied
Interventions
- DEVICE Active - HD tDCS
- DEVICE Sham - HD tDCS
Study Locations (1)
California
- University of California, Los Angeles (UCLA) - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2020-12-01 |
| Est. Completion | 2024-03-07 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04507243
The ClinicalTrials.gov registry entry for NCT04507243 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 72 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (81% lower). The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Active - HD tDCS is the first listed.
NCT04507243 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT04507243 about?
NCT04507243 is a clinical study titled "Transcranial Direct Current Stimulation (tDCS) Therapy in Major Depression". Noninvasive transcranial direct current stimulation (tDCS) is a low-intensity neuromodulation technique of minimal risk that has been used as an experimental procedure for reducing depressive symptoms and symptoms of other brain disorders. Though tDCS applied to prefrontal brain areas is shown to re...
What is the current status of trial NCT04507243?
This trial is currently completed. It is a NA study. The enrollment target is 72 participants. The study started on 2020-12-01. Estimated completion is 2024-03-07.
What conditions does trial NCT04507243 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT04507243?
The interventions under investigation include: Active - HD tDCS (DEVICE), Sham - HD tDCS (DEVICE).
Who is sponsoring clinical trial NCT04507243?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04507243 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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