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Procedure

Non-invasive Transcranial Focused Ultrasound for Depression (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

DMNtFUS Trial 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.Check my eligibility

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.See study design

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.

DMNtFUS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Beck Depression Inventory - II (BDI-II)

Default Mode Network (DMN) Connectivity

Hamilton Depression Rating Scale (HDRS)

+1 more

Secondary outcome measures

The Montgomery-Åsberg Depression Rating Scale (MADRS)

DMNtFUS 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

OpenwaterUNKNOWN

University of ArizonaLead Sponsor

514 Previous Clinical Trials

148,574 Total Patients Enrolled

20 Trials studying Depression

3,204 Patients Enrolled for Depression

John JB Allen, PhDPrincipal InvestigatorUniversity of Arizona Psychology Department

1 Previous Clinical Trials

108 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals meet the eligibility criteria to participate in this study?

"Individuals aged between 18 and 50 years old with a diagnosis of major depressive disorder are eligible to participate in this study, which aims to enroll approximately 20 subjects."

Answered by AI

Is the trial open to individuals who are below 65 years of age?

"Eligible candidates for this research initiative must fall within the age range of 18 to 50. Notably, there are a substantial number of clinical trials available specifically for participants under 18 years old as well as those over 65 years old, amounting to 227 and 1045 trials respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Altering Default Mode Network Activity With Transcranial Focused Ultrasound to Reduce Depressive Symptoms

John Allen 2023. "Altering Default Mode Network Activity With Transcranial Focused Ultrasound to Reduce Depressive Symptoms". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06320028.

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