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NCT03851380 · ClinicalTrials.gov record · last posted 2026-08-03

Improving Brain Stimulation Through Imaging

Study acronym: IBSI
StatusCompleted
PhaseNot specified
Started2019-09-30
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from the ClinicalTrials.gov record
There are two protocols, one involving rTMS therapy in people with treatment resistant depression and one involving tDCS in people with stress from the COVID 19 pandemic. Clinic-Based rTMS Therapy: 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. Home-Based Neuromodulation: 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 whom we're studying the effect of neuromodulation on functioning.

Protocol amendment history 3 changes detected by DataLookout

2026-08-04
notable
Trial completed
2026-08-04
critical
Primary endpoint(s) modified
WasVeterans RAND 36-Item, World Health Organization Disability Assessment Schedule 2.0
NowAcceptable distance between TMS treatment location and brain target: Anticorrelation with Subgenual Cingulate, Acceptable distance between TMS treatment location and brain target: fMRI Emotional Working Memory
2026-08-04
minor
Completion moved earlier: 2026-05-01 → 2024-07-31
Trial Details
NCT Number NCT03851380
Lead Sponsor VA Office of Research and Development
Collaborators: Providence VA Medical Center, Atlanta VA Medical Center
Conditions Depression, Depressive Disorder, Treatment-Resistant, COVID Stress, PTSD - Post Traumatic Stress Disorder
Enrollment 54 participants
Start Date 2019-09-30
Primary Completion 2024-07-31 (estimated)
Study Completion 2024-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-03