Efficacy of Clinical Application of Transcranial Low Intensity Focused Ultrasonic Stimulation for Patients With Major Deperessive Disorder - Exploratory Clinical Trial

PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

June 12, 2019

Primary Completion Date

March 2, 2021

Study Completion Date

March 19, 2021

Conditions
Major Depressive Disorder(MDD)
Interventions
PROCEDURE

Active stimulation group Sham stimluation group

"Participants are randomly assigned to either treatment group or sham group for application of transcranial low intensity focused ultrasound stimulation. For sham group, transducer is surrounded by rubber band in order to block the transmission of ultrasonic wave.~Before initiating transcranial low intensity focused ultrasonic stimulation, in order to identify anatomical structure of the brain, Brain Magnetic Resonance Image(MRI) and Computer Tomography(CT) will be taken. For image coordination, multi-modal stick(fiducial marker, PinPoint) will be attached to the participant.~With acquired brain images of the participant, researchers identify participant's dorsolateral prefrontal cortex(DLPFC) region, and design focused ultrasound focus targeting, image-guidance method.~The treatment is started by targeting left DLPFC region according to assigned groups. Both the treatment and sham group will be under procedure for 2 weeks, 3 times a week."

Trial Locations (1)

Unknown

GangnamSeverance Hospital, Seoul

All Listed Sponsors
lead

Gangnam Severance Hospital

OTHER

NCT04405791 - Efficacy of Clinical Application of Transcranial Low Intensity Focused Ultrasonic Stimulation for Patients With Major Deperessive Disorder - Exploratory Clinical Trial | Biotech Hunter | Biotech Hunter