Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03577106 · ClinicalTrials.gov registry record · NA
A Pilot fMRI Study of TMS in Late-Life Severe Worry
A NA study of Anxiety Disorders Generalized, sponsored by Carmen Andreescu.
- Completed
- Registry status
- NA
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT03577106 is a NA study of Anxiety Disorders Generalized that has completed, run by Carmen Andreescu. The registered enrollment target is 24 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03577106, a NA study of Anxiety Disorders Generalized, has completed, sponsored by Carmen Andreescu.
- COMPLETED
- Registry status
- NA
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Investigators will test a novel intervention through experimental therapeutic approach using fMRI-directed Intermittent Theta Burst Stimulation (iTBS), a high frequency TMS paradigm, for the treatment of severe, uncontrollable worry. While worry is a universal human experience, severe and excessive worry has been recently linked to increased risk of stroke and other cardiovascular diseases, increased risk of conversion to Alzheimer's disease as well as to higher risk of all-cause mortality in midlife and late-life. Severe, uncontrollable worry has been repeatedly associated with reduced quality of life and impaired functioning. Current treatment choices (antidepressant/anxiolytic medications and psychotherapeutic interventions) have been proven moderately efficacious in reducing anxiety/depression burden, but ineffective in reducing worry severity, a phenomenon that may contribute to the high relapse rates associated with mood and anxiety disorders. Our research indicated that worry severity is associated with hyperactivation in specific regions such as orbital frontal cortex, superior parietal gyrus, amygdala and parahippocampal gyrus. This pilot study will explore the efficacy of targeting one of these regions with iTBS. Based on investigators' previous results, the most accessible target is the right superior parietal gyrus (rSPG) - a region that remained significantly associated with severe worry after controlling for effects of comorbid depression or overall anxiety. As this region showed an increased in cerebrovascular flow in association with worry severity, investigators will use iTBS (5x/week for 2 weeks) to modulate cortical plasticity in this region and consequently, to reduce worry severity. TMS during wakefulness has been shown to alter subsequent sleep \[4\], Further, changes in sleep in response to TMS has been associated with how participants respond to the TMS as a treatment \[5\]. Thus, the study will measure sleep throughout the protocol to deter
Conditions Studied
Interventions
- DEVICE Transcranial magnetic stimulation (TMS)
Study Locations (1)
Pennsylvania
- University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-12-06 |
| Est. Completion | 2022-05-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03577106
The ClinicalTrials.gov registry entry for NCT03577106 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Carmen Andreescu, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Anxiety Disorders Generalized appearing as the primary indexed condition, and to 1 intervention - of which Transcranial magnetic stimulation (TMS) is the first listed.
NCT03577106 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03577106 about?
NCT03577106 is a clinical study titled "A Pilot fMRI Study of TMS in Late-Life Severe Worry". Investigators will test a novel intervention through experimental therapeutic approach using fMRI-directed Intermittent Theta Burst Stimulation (iTBS), a high frequency TMS paradigm, for the treatment of severe, uncontrollable worry. While worry is a universal human experience, severe and excessive ...
What is the current status of trial NCT03577106?
This trial is currently completed. It is a NA study. The enrollment target is 24 participants. The study started on 2018-12-06. Estimated completion is 2022-05-04.
What conditions does trial NCT03577106 study?
This clinical trial studies the following conditions: Anxiety Disorders Generalized.
What interventions are being tested in trial NCT03577106?
The interventions under investigation include: Transcranial magnetic stimulation (TMS) (DEVICE).
Who is sponsoring clinical trial NCT03577106?
This trial is sponsored by Carmen Andreescu, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03577106 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.