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Using rTMS to Treat Depression

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 1, 2026 → Sep 1, 2027
See other at-risk trials from Florida International University

Record History

  1. Notable Primary completion pushed from Sep 1, 2026 to Sep 1, 2027
    • Study completion pushed from Sep 25, 2026 to Sep 25, 2027
    v9
  2. Notable Primary completion date: Sep 1, 2025 to Sep 1, 2026
    • Publications: details revised at 4 of 4 entries
    v8
  3. Minor Study completion date: Sep 25, 2025 to Sep 25, 2026v7
  4. Notable Primary completion date: Dec 24, 2024 to Sep 1, 2025v6
  5. Minor Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jul 28, 2024 to Dec 24, 2024
    • Site details revised
    • Publications: details revised at 4 of 4 entries
    v5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Primary completion date: Feb 26, 2024 to Jul 28, 2024v4
  2. Notable Trial status: Active, Not Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Mar 25, 2022 to Feb 26, 2024
    • Start date: Sep 9, 2021 to Jan 9, 2023
    • Study completion date: Sep 25, 2024 to Sep 25, 2025
    • Site details revised
  3. Minor Study completion date: Jul 25, 2022 to Sep 25, 2024v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Repetitive Transcranial Magnetic Stimulation (rTMS) is a promising, novel, non-invasive therapy for depression. In fact, there is an FDA-approved depression protocol to stimulate the dorsolateral prefrontal cortex (dlPFC). Its efficacy and safety have improved significantly with continued research and clinical experience. However, it is not known how to identify potential patients who would benefit most from treatment. The primary goal of this study is to determine if changes in specific electroencephalogram (EEG) parameters after treatment can predict whether patients are responders or non-responders to rTMS. The second objective is to analyze changes in the functional connectivity of specific brain regions in responders compared to non-responders. The hypothesis is that through rTMS treatment, investigators will be able to increase the activity in the frontal region that includes the dorsolateral prefrontal cortex (DLPFC). Scalp EEG signals will be processed in order to compare EEG brain connectivity and Frontal alpha asymmetry index (FAA) to determine if there are differences before and after the treatment. EEG FAA is usually calculated by subtracting the right-side EEG power estimates from the respective counterpart on the other side. According to literature, depressive patients seem to have comparatively higher left frontal alpha power. Cortical activity is related to a reduced EEG power, which is reflected in depressed subjects. On the other hand, higher alpha power could also be interpreted as inhibition. Investigators will try to delineate changes in resting EEG functional connectivity before and after high-frequency left prefrontal rTMS, by using biomarkers such as: time/frequency connectivity, Alpha asymmetry index, among others. TMS also allows cortical properties, such as excitability, inhibition, oscillatory activity and connectivity to be directly probed within a specific region of the cortex. Other studies suggest that alterations in gamma oscillations in the dorsolateral prefrontal cortex and neighboring frontal regions are also potential shared biomarkers in psychiatry, highlighting the potential of EEG signals to help identify suitable biomarkers. Given its relative low cost and ease of use, when compared to brain imaging tools such as magnetic resonance imaging (MRI) or positron emission tomography (PET), EEG could be added to the clinical study so that precise neurophysiological changes before and after treatments can be assessed.
Trial Details
NCT Number NCT05424224
Lead Sponsor Florida International University
Conditions
(from sponsor)
Depression
Related terms Depression
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov