NCT04405791

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

Completed Phase 3 Last updated 17 March 2022

What this trial tests

Phase 3 trial testing Active stimulation group Sham stimluation group in Major Depressive Disorder(MDD) in 30 participants. Completed in 19 March 2021.

Timeline

12 June 2019

Primary endpoint
2 March 2021

19 March 2021

Quick facts

Lead sponsor	Gangnam Severance Hospital
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	30
Start date	12 June 2019
Primary completion	2 March 2021
Estimated completion	19 March 2021
Sites	1 location across South Korea

Drugs / interventions tested

• Active stimulation group Sham stimluation group

Conditions studied

• Major Depressive Disorder(MDD) — all drugs for Major Depressive Disorder(MDD) →

Sponsor

Gangnam Severance Hospital

Who can join

Adults 19 to 60, any sex, with Major Depressive Disorder(MDD). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Safety Review and Perspectives of Transcranial Focused Ultrasound Brain Stimulation.
   Lee W, Weisholtz DS, Strangman GE, Yoo SS. · · 2021 · cited 54× · PMID 36742103 · DOI 10.12786/bn.2021.14.e4
2. Effect of Low-Intensity Transcranial Focused Ultrasound Stimulation in Patients With Major Depressive Disorder: A Randomized, Double-Blind, Sham-Controlled Clinical Trial.
   Oh J, Ryu JS, Kim J, Kim S, et al · · 2024 · cited 32× · PMID 39111747 · DOI 10.30773/pi.2024.0016
3. Current state of clinical ultrasound neuromodulation.
   Matt E, Radjenovic S, Mitterwallner M, Beisteiner R. · · 2024 · cited 27× · PMID 38962179 · DOI 10.3389/fnins.2024.1420255
4. Ultrasound Applications in the Treatment of Major Depressive Disorder: A Systematic Review of Techniques and Therapeutic Potentials in Clinical Trials and Animal Model Studies.
   Tan G, Chen H, Leuthardt EC. · · 2026 · cited 1× · PMID 41105071 · DOI 10.1016/j.neurom.2025.08.001