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NCT06320028 · ClinicalTrials.gov registry record · Phase 1
Altering Default Mode Network Activity With Transcranial Focused Ultrasound to Reduce Depressive Symptoms
A Phase 1 study of Depression and Depressive Disorder, Major, sponsored by University of Arizona.
- Active
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06320028 is a Phase 1 study of Depression and Depressive Disorder, Major that is active but no longer recruiting, run by University of Arizona. The registered enrollment target is 20 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06320028, a Phase 1 study of Depression and Depressive Disorder, Major, is active but no longer recruiting, sponsored by University of Arizona.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Depression is a leading cause of disability worldwide, affecting roughly 21 million adults. Repetitive Negative Thought (RNT) has been identified as a potential maintaining factor in depression, such that those who exhibit higher degrees of RNT endorse greater symptoms. Research also suggests that the Default Mode Network (DMN), responsible for self-referential processing, plays an important role in depression wherein it has been linked to RNT. In depressed individuals, this network appears to be hyper-connected, or "too connected", within itself which, in turn, is thought to promote RNT. Half of depressed individuals are treatment-resistant, creating a critical need to identify more effective interventions derived from a better mechanistic understanding of the development and maintenance of depression. Non-invasive Transcranial-Focused Ultrasound Stimulation (tFUS) is promising for the treatment of depression. tFUS directs a low-intensity (nonthermal) focused ultrasound beam that passes safely through the skull. Compared to other noninvasive neuromodulation approaches, tFUS can target deeper brain regions with high spatial precision. The present study is an exploratory non-blinded single treatment study to investigate whether tFUS targeting a major hub of the DMN, the anterior-medial prefrontal cortex, can improve depression symptoms and reduce RNT. Twenty depressed individuals with high RNT (75th percentile) will complete up to eleven ultrasound sessions targeting the anterior medial prefrontal cortex, a hub of the brain's default mode network that has been found to be hyper-connected in depression. MRI scans will be obtained before the first and after the last ultrasound sessions. Based on previous literature, it is predicted that depression interview ratings and self-report symptoms will decrease after the intervention, and also that DMN connectivity will decrease following intervention.
Conditions Studied
Interventions
- DEVICE Non-Invasive Transcranial Focused Ultrasound
Study Locations (1)
Arizona
- University of Arizona - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-04-27 |
| Est. Completion | 2024-06-03 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06320028
The ClinicalTrials.gov registry entry for NCT06320028 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower). The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Non-Invasive Transcranial Focused Ultrasound is the first listed.
NCT06320028 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT06320028 about?
NCT06320028 is a clinical study titled "Altering Default Mode Network Activity With Transcranial Focused Ultrasound to Reduce Depressive Symptoms". Depression is a leading cause of disability worldwide, affecting roughly 21 million adults. Repetitive Negative Thought (RNT) has been identified as a potential maintaining factor in depression, such that those who exhibit higher degrees of RNT endorse greater symptoms. Research also suggests that t...
What is the current status of trial NCT06320028?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-04-27. Estimated completion is 2024-06-03.
What conditions does trial NCT06320028 study?
This clinical trial studies the following conditions: Depression, Depressive Disorder, Major.
What interventions are being tested in trial NCT06320028?
The interventions under investigation include: Non-Invasive Transcranial Focused Ultrasound (DEVICE).
Who is sponsoring clinical trial NCT06320028?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06320028 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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