Low-Intensity Focused Ultrasound for Treatment-Resistant Depression

NCT06013384 | Suspended FDA Device

• 1 other identifier: Pro00128763
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The Investigators are proposing to demonstrate safety and efficacy of LIFUP for treatment resistant major depressive disorder in a ten-patient pilot study. LIFUP is an emerging treatment with the advantage of being able to target subcortical transcranial targets, which may have superior efficacy or a shorter treatment course compared to other available treatments such as transcranial magnetic stimulation. This study will investigate the effect of this stimulation on the left subgenual cingulate cortex, a highly connected node in the depression network that is correlated with clinical symptomatology.

Conditions

Major Depressive Disorder; Treatment Resistant Depression

Keywords

focused ultrasound; neuromodulation

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS) Score Change

  Change in the MADRS score, which ranges from 0-60, with 0-8 = no depression; 9-17 = mild; 18-34 = moderate; and \>35 = severe

  One week post-treatment

Secondary Outcomes (2)

• Patient Health Questionnaire (PHQ-9) Score Change

  One week post-treatment

• General Anxiety Disorder (GAD-7) Score Change

  One week post-treatment

Study Arms (2)

Active/Active Group

EXPERIMENTAL

This group will receive eight total treatments of LIFUP across two days one week apart (four treatments each day).

Device: Low-Intensity Focused Ultrasound Pulsation

Sham/Active Group

OTHER

This group will receive sham LIFUP for four treatments over one day, followed by four total treatments of active LIFUP across one day one week after sham.

Device: Low-Intensity Focused Ultrasound Pulsation; Device: Sham Low-Intensity Focused Ultrasound Pulsation

Interventions

Low-Intensity Focused Ultrasound Pulsation DEVICE

Low-intensity focused ultrasound pulsation will be directed towards the target region at FDA-approved intensity levels in treatment sessions one and two.

Active/Active Group; Sham/Active Group

Sham Low-Intensity Focused Ultrasound Pulsation DEVICE

Sham low-intensity focused ultrasound pulsation will be given.

Sham/Active Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Age 18-70
• Normal or corrected-to normal vision and hearing
• Primary diagnosis of major depressive disorder, moderate/severe per DSM-5 (MADRS \>20)
• The duration of the illness must exceed one year
• Must be medically stable as determined by investigator
• Patient must have attempted and failed treatment with at least 2 SSRI and 1 augmentation
• History of rTMS is permitted, but not required
• Diagnosis of primary DSM-5 depressive disorder other than MDD
• Anxiety disorders such as GAD are permitted as long as MDD is primary
• Diagnosis of schizophrenia or bipolar disorder
• Current use of any non-prescribed psychoactive medications or drugs (aside from medications for treatment of MDD)
• Contraindication to enter the MRI environment.
• Pregnancy (or suspected/possible pregnancy or plan to become pregnant in the short term).
• Urine Pregnancy Test: If the subject is a woman of childbearing potential and /or a man capable of fathering a child before, during, and/or after participation precaution should be taken. Examples of acceptable methods of birth control for participants involved in the study includes: birth control pills, patch, IUD, condom, sponge, diaphragm with spermicide, or avoiding sexual activity that could cause the subject to become pregnant.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

30 Bee Street

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 28, 2023
• Study Start: February 16, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)