NCT04405791

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The non-invasive type ultrasonography system is applied to patients with major depressive disorder to evaluate their effectiveness and safety. Brain Computer Tomography(CT) and Magnetic Resonance Image(MRI) are taken to induce images before transcranial low intensity focused ultrasonic stimulation. Through random extraction, the group is divided into treatment group and placebo group. The treatment is started by targeting left Dorsolateral prefrontal cortex(DLPFC) region according to assigned groups. As for women, considering mood change during menstrual cycle, the treatment is taken place 1 week after the menstruation has initiated. The treatment group and the placebo group will be treated three times a week for two weeks. To evaluate clinical symptoms, Quick Inventory of Depressive Symptomatology-Self Report, Scale for Suicidal Ideation, state-trait anxiety scale, frontal lobe management function test, memory test, and continuous performance test are performed before, during, and after treatment. For the assessment of side effects, Systematic Asseseement for Treatment Emergent Events-General Inquiry(SAFTEE) are conducted for treatment presentation events every week during the treatment implementation period and every two weeks after the treatment is completed.

Conditions

• Major Depressive Disorder(MDD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-06-12
• Primary completion: 2021-03-02
• Completion: 2021-03-19
• First posted: 2020-05-28
• Last updated: 2022-03-17

Locations

1 site across 1 country: South Korea