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NCT05147142 · ClinicalTrials.gov registry record · NA
Low Intensity Focused Ultrasound: a New Paradigm for Depression and Anxiety
A NA study of Depression, sponsored by Ocean State Research Institute.
- Active
- Registry status
- NA
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT05147142: Active NA study of Depression, sponsored by Ocean State Research Institute.
NCT05147142 is a NA study of Depression that is active but no longer recruiting, run by Ocean State Research Institute. The registered enrollment target is 25 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. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05147142, a NA study of Depression, is active but no longer recruiting, sponsored by Ocean State Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Objective: Preliminary studies show that low intensity focused ultrasound (LIFU), a new type of non invasive brain stimulation, may be able to reach deep structures of the brain involved with depression and anxiety, that remain inaccessible using current forms of non-invasive brain stimulation with precision. In this study, the investigators will test if this technique can be used to change brain activity in areas that are connected to depression and anxiety symptoms. The primary objectives of this study are to test the safety and tolerability of LIFU, evaluate the feasibility of using LIFU to reduce brain activity, and evaluate the feasibility of simultaneous fMRI-LIFU. If the results of this study are positive, what the investigators learn will serve as a strong foundation for the future development of innovative treatments for a variety of psychiatric disorders. Research Procedures: 25 veterans will be recruited. Visits will take place at the VA Providence Healthcare System. During some visits, healthy and patient participants may undergo clinical and research neuroimaging, neuropsychological testing, complete questionnaires, and participate in clinical/neurological assessments. Healthy veterans will not receive LIFU and will only attend 2 study visits. Patients are expected to attend up to 8 visits over 6 weeks. However, some may require up to 6 extended follow-ups after visits 5 or 8, in which case they would attend a total of 11 or 14 visits over 6 months. Two patient visits will include the LIFU application, following FDA safety guidelines. Patients will be assigned either to an experiment in which LIFU stimulation will be delivered immediately prior to a task or to an experiment in which stimulation will be delivered during the task. Within each experiment, patients will be assigned to first receive either LIFU stimulation to the study target or anatomical control. Study staff, but not participants will know which location is being targeted in case safety c
Conditions Studied
Interventions
- DEVICE Low Intensity Focused Ultrasound
Study Locations (1)
Rhode Island
- VA Providence Healthcare System - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2021-09-28 |
| Est. Completion | 2026-03 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05147142
The ClinicalTrials.gov registry entry for NCT05147142 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 25 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 Ocean State Research Institute, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 1 intervention - of which Low Intensity Focused Ultrasound is the first listed.
NCT05147142 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.
Frequently Asked Questions
What is clinical trial NCT05147142 about?
NCT05147142 is a clinical study titled "Low Intensity Focused Ultrasound: a New Paradigm for Depression and Anxiety". Objective: Preliminary studies show that low intensity focused ultrasound (LIFU), a new type of non invasive brain stimulation, may be able to reach deep structures of the brain involved with depression and anxiety, that remain inaccessible using current forms of non-invasive brain stimulation with ...
What is the current status of trial NCT05147142?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 25 participants. The study started on 2021-09-28. Estimated completion is 2026-03.
What conditions does trial NCT05147142 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT05147142?
The interventions under investigation include: Low Intensity Focused Ultrasound (DEVICE).
Who is sponsoring clinical trial NCT05147142?
This trial is sponsored by Ocean State Research Institute, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05147142 being conducted?
This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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