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Brain Stimulation

Ultrasonic Brain Stimulation for Depression

Phase 1 & 2
Recruiting
Led By Brian J Mickey, MD, PhD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-65, any gender
Primary diagnosis of major depressive disorder or bipolar disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day at mri study visit
Awards & highlights

Study Summary

This trial will test a new non-invasive brain stimulation technique on people with depression, to see if it is effective and safe.

Who is the study for?
Adults aged 18-65 with a primary diagnosis of major depressive disorder or bipolar disorder, currently experiencing a moderate-to-severe depressive episode without psychotic features for at least 2 months. Participants must not change psychiatric treatments during the study and women must use effective contraception.Check my eligibility
What is being tested?
The trial is testing the Diadem prototype, which uses personalized low-intensity focused ultrasound to stimulate the brain non-invasively. The effects will be monitored psychologically and physiologically, then assessed through MRI in a blinded sham-controlled cross-over design.See study design
What are the potential side effects?
Potential side effects are not specified but may include discomfort from wearing the device, headache or dizziness post-stimulation. Since it's non-invasive and doesn't involve drugs, traditional medication side effects are unlikely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been diagnosed with major depressive disorder or bipolar disorder.
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I have been feeling very down or depressed for at least 2 months without losing touch with reality.
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I agree to follow the study rules and not change my mental health treatments during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day at mri study visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day at mri study visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mood effects: momentary mood change
Mood effects: subjective mood state
Target engagement: MRI quantification of brain activation
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active stimulationExperimental Treatment1 Intervention
Personalized low-intensity transcranial focused ultrasound stimulation of deep brain target (subgenual cingulate or alternative targets)
Group II: Sham stimulationPlacebo Group1 Intervention
Personalized low-intensity transcranial focused ultrasound stimulation of lateral ventricle

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,091 Previous Clinical Trials
1,732,542 Total Patients Enrolled
Brian J Mickey, MD, PhDPrincipal InvestigatorUniversity of Utah
1 Previous Clinical Trials
48 Total Patients Enrolled

Media Library

Diadem prototype (Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05301036 — Phase 1 & 2
Major Depression Research Study Groups: Active stimulation, Sham stimulation
Major Depression Clinical Trial 2023: Diadem prototype Highlights & Side Effects. Trial Name: NCT05301036 — Phase 1 & 2
Diadem prototype (Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05301036 — Phase 1 & 2

Frequently Asked Questions

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

Are there any positions available for test subjects?

"That is accurate. According to the information provided on clinicaltrials.gov, this study was posted on 7/15/2022 and last updated on 8/27/2022. The trial is still recruiting patients and needs 20 more individuals from 1 site."

Answered by AI

How many total subjects are enrolled in this research project?

"That is correct, the online clinical trials database does show that this research is actively looking for volunteers. This particular trial was first publicized on July 15th, 2022 and received its most recent update on August 27th, 2022. The study needs 20 more participants and is only recruiting at a single site."

Answered by AI

Are elderly patients being accepted into this program?

"The age range for potential participants in this trial are those individuals who have surpassed 18 years old, but have not yet reached 65 years of age."

Answered by AI

Are there specific inclusion criteria for participants in this clinical trial?

"This study is looking for 20 participants that currently suffer from a major depressive episode. The ideal candidate will also meet the following criteria: be aged 18-65, of any gender identity, have a primary diagnosis of either major depressive disorder or bipolar disorder, experience current moderate-to-severe depression lasting at least 2 months without psychotic features, and be willing to comply with all procedures and forego changes to psychiatric treatments for the duration of the study. For females of reproductive potential, they must provide a negative pregnancy test or use highly effective contraception for at least one month prior to baseline and agree to continue using such methods throughout the study."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
University of Utah
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~3 spots leftby Jul 2024