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: Completed NA study of Anxiety Disorders Generalized, sponsored by Carmen Andreescu.
NCT03577106 is a NA study of Anxiety Disorders Generalized that has completed, run by Carmen Andreescu. The registered enrollment target is 24 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Penn State Worry Questionnaire (PSWQ) scores range from 16 to 80 with higher levels indicating greater worry severity.
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 |
What the finished NCT03577106 record still lists
NCT03577106 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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
How this trial's enrollment target compares
Where NCT03577106's enrollment target sits among peer trials
24 1736th of 2000 higher than 246 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02331979 · 24 participants · NA
Improving Bladder Function in SCI by Neuromodulation
- NCT03096197 · 24 participants · NA
Exoskeleton and Spinal Cord Stimulation for SCI
- NCT03223922 · 24 participants · NA
Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases
- NCT03326921 · 24 participants · Phase 1
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI