Altering Default Mode Network Activity With Transcranial Focused Ultrasound to Reduce Depressive Symptoms (DMNtFUS Trial)

Phase 1 & 2

Waitlist Available

Led By John JB Allen, PhD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before ultrasound treatment, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study how a new treatment using ultrasound stimulation can help improve depression symptoms in individuals who have repetitive negative thoughts. Depression affects many people and can be difficult to treat, so new approaches are

Who is the study for?

This trial is for adults with Major Depressive Disorder who often have repetitive negative thoughts. Participants should be among the top 25% in terms of how much they experience these thoughts. They must not have conditions that exclude them from safely receiving ultrasound treatments to their brain.

What is being tested?

The study tests if a non-invasive technique called Transcranial Focused Ultrasound (tFUS) can reduce symptoms of depression by targeting and altering activity in a specific part of the brain linked to negative thinking patterns.

What are the potential side effects?

Potential side effects are not detailed, but as tFUS is non-invasive and uses low-intensity ultrasound, risks may be minimal compared to other forms of neuromodulation. However, any discomfort or unexpected reactions will be monitored.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before ultrasound treatment, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before ultrasound treatment, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable)

This trial's timeline: 3 weeks for screening, Varies for treatment, and before ultrasound treatment, after completion of week 1 of treatment, after completion of week 3 of treatment (if applicable) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Beck Depression Inventory - II (BDI-II)

Default Mode Network (DMN) Connectivity

Hamilton Depression Rating Scale (HDRS)

+1 more

Secondary study objectives

The Montgomery-Åsberg Depression Rating Scale (MADRS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Non-invasive Transcranial Focused UltrasoundExperimental Treatment1 Intervention

Device: Transcranial Ultrasound Power The ultrasound will be delivered using a custom Neuromodulation device consisting of 128 element ultrasound array (Openwater) with the ultrasound beam having the following parameters: acoustic frequency = 400 kHz, pulse duration = 5 ms, pulse repetition rate (PRR) = 10 Hz, spatial peak/temporal average acoustic intensity = 435 mW /cm2, peak negative pressure 650 kPa. The ultrasound probe will be secured by a custom-designed headset created by Openwater. The Localite Neuronavigation Software (TMS Navigator 3.3 adapted for ultrasound device), including a 3D camera, fiducial markers on the headset and pointer, and software will register the position of the probe with respect to the patient's structural MRI.

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