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Active Not RecruitingNCT05301036

Personalized Ultrasonic Brain Stimulation for Depression

Personalized Ultrasonic Brain Stimulation for Depression: A Pilot Study of Target Engagement and Mood Effects

Status
Active Not Recruiting
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
20 (estimated)
Sponsor
University of Utah · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

This study will evaluate a new form of non-invasive brain stimulation for individuals with depression. Personalized low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychological and physiological monitoring. A well-tolerated stimulation protocol will then be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial to evaluate brain target engagement using magnetic resonance imaging.

Conditions

Interventions

TypeNameDescription
DEVICEDiadem prototypeDiadem prototype device delivers personalized low-intensity transcranial focused ultrasound stimulation

Timeline

Start date
2022-07-15
Primary completion
2024-07-14
Completion
2024-12-14
First posted
2022-03-29
Last updated
2024-08-09

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05301036. Inclusion in this directory is not an endorsement.

Personalized Ultrasonic Brain Stimulation for Depression (NCT05301036) · Clinical Trials Directory