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Personalized Ultrasonic Brain Stimulation for Depression

NCT05301036 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-08-09

No results posted yet for this study

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

  • Major Depressive Episode

Interventions

DEVICE

Diadem prototype

Diadem prototype device delivers personalized low-intensity transcranial focused ultrasound stimulation

Sponsors & Collaborators

Principal Investigators

  • Brian J Mickey, MD, PhD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-15
Primary Completion
2024-07-14
Completion
2024-12-14

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05301036 on ClinicalTrials.gov