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NCT03851380 · ClinicalTrials.gov registry record
Improving Brain Stimulation Through Imaging
A clinical trial of Depression and Depressive Disorder, Treatment-Resistant, sponsored by VA Office of Research and Development.
- Active
- Registry status
- 54
- Enrollment target
- 1
- Study location
NCT03851380: Active study of Depression and Depressive Disorder, Treatment-Resistant, sponsored by VA Office of Research and Development.
NCT03851380 is a study of Depression and Depressive Disorder, Treatment-Resistant that is active but no longer recruiting, run by VA Office of Research and Development. The registered enrollment target is 54 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03851380, a study of Depression and Depressive Disorder, Treatment-Resistant, is active but no longer recruiting, sponsored by VA Office of Research and Development.
- ACTIVE NOT RECRUITING
- Registry status
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
Repetitive pulse transcranial magnetic stimulation (rTMS) is a noninvasive treatment that involves stimulating the brain; however, treatment benefit depends on placing a TMS coil in the correct place on the head to reach critical brain regions below. Clinicians typically use scalp-based targeting, a process in which rather than using MRI guidance to target brain regions for stimulation, they use landmarks on the scalp. Several researchers, including the investigators' lab, showed that the current scalp-based targeting techniques do not position stimulation above the correct brain region, and patients fail to respond. The investigators propose to improve clinical scalp-based targeting by comparing it to MRI guided targeting. The most common clinical population receiving rTMS therapy is depressed patients. The investigators' plan is to study the accuracy of certain scalp-based rules in patients with depression. Accurate brain stimulation targeting is critical for effective rTMS therapy. For participants who are not undergoing rTMS therapy who have COVID-19 distress, we are offering a combined home-based neuromodulation (transcranial electrical stimulation) and focused psychotherapy program dedicated to improving the same outcome measure, quality of life. Transcranial electrical stimulation (tES) stimulates the brain over a large region; however, we are able to model with brain imaging which brain regions receive the strongest stimulation. Our goal is still to examine stimulation precision, but we will test whether strength of tES in the same brain regions that rTMS is targeting will also lead to improved quality of life. We will also carefully assess whether it is possible to measure healthy functioning, an outcome in the rTMS study, because sheltering in place may reduce activities and thus distort our measure. We will also test whether our psychotherapy intervention will mitigate this effect and, if so, we may make it available to all those depressed Veterans in wh
Primary Outcome
Targeting accuracy was defined as being within 1.36 cm which is within the resolution of the TMS coil and which should be achievable based on work by Mir-Moghtadaei et al 2015 comparing to a fixed coordinate. The anticorrelation with the subgenual cingulate is a resting-state functional connectivity-based target that has evidence of being effective in reducing depression (Cash et al, 2020)
Conditions Studied
Interventions
- BEHAVIORAL Psychological / Functional Assessment
- OTHER Structural and Functional MRI
- DEVICE Transcranial Magnetic Brain Stimulation and MR Image Guidance
- DEVICE Transcranial Electrical Stimulation (tES)
Study Locations (1)
California
- VA Palo Alto Health Care System, Palo Alto, CA - Palo Alto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2019-09-30 |
| Est. Completion | 2026-05-01 |
What the registry record for NCT03851380 still lists
NCT03851380 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 786-participant average among 679 other Depression trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Depression appearing as the primary indexed condition, and to 4 interventions - of which Psychological / Functional Assessment is the first listed.
NCT03851380 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03851380 about?
NCT03851380 is a clinical study titled "Improving Brain Stimulation Through Imaging". Repetitive pulse transcranial magnetic stimulation (rTMS) is a noninvasive treatment that involves stimulating the brain; however, treatment benefit depends on placing a TMS coil in the correct place on the head to reach critical brain regions below. Clinicians typically use scalp-based targeting, a...
What is the current status of trial NCT03851380?
This trial is currently active not recruiting. The enrollment target is 54 participants. The study started on 2019-09-30. Estimated completion is 2026-05-01.
What conditions does trial NCT03851380 study?
This clinical trial studies the following conditions: Depression, Depressive Disorder, Treatment-Resistant, COVID Stress.
What interventions are being tested in trial NCT03851380?
The interventions under investigation include: Psychological / Functional Assessment (BEHAVIORAL), Structural and Functional MRI (OTHER), Transcranial Magnetic Brain Stimulation and MR Image Guidance (DEVICE), Transcranial Electrical Stimulation (tES) (DEVICE).
Who is sponsoring clinical trial NCT03851380?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03851380 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03851380's enrollment target sits among peer trials
54 457th of 679 higher than 219 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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