Low-Intensity Focused Ultrasound for Treatment-Resistant Depression

Not Applicable

Suspended

• Conditions: Treatment Resistant Depression; Major Depressive Disorder
• Interventions: Device: Low-Intensity Focused Ultrasound Pulsation; Device: Sham Low-Intensity Focused Ultrasound Pulsation

• Registration Number: NCT06013384
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

The purpose of this pilot study is to evaluate safety and efficacy of a novel treatment, low intensity focused ultrasound pulsation (LIFUP) for treatment resistant depression (TRD). Participants will receive either LIFUP or sham stimulation with crossover of sham participants into the treatment group halfway through the treatment course. The initial visit will involve consent and an MRI scan, followed by several more either active or sham treatments outside of the MRI environment delivered over the course of two days over one week. Response and potential side effects will be monitored pre- and post- each treatment along with one week and one month follow-up assessments.

Study Timeline

• Study First Submitted: 2023-08-22
• Study First Submitted QC: 2023-08-22
• Study First Posted: 2023-08-28
• Study Start: 2024-02-16
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-21
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active/Active Group	Low-Intensity Focused Ultrasound Pulsation	This group will receive eight total treatments of LIFUP across two days one week apart (four treatments each day).
Sham/Active Group	Sham Low-Intensity Focused Ultrasound Pulsation	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.
Sham/Active Group	Low-Intensity Focused Ultrasound Pulsation	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.

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS) Score Change	One week post-treatment	Change in the MADRS score, which ranges from 0-60, with 0-8 = no depression; 9-17 = mild; 18-34 = moderate; and \>35 = severe

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9) Score Change	One week post-treatment	Change in PHQ-9 Score, which ranges from 0-27, with 0-4 = no depression; 5-9 = mild; 10-14 = moderate; and \>15 = severe
General Anxiety Disorder (GAD-7) Score Change	One week post-treatment	Change in GAD-7 Score, which ranges from 0-21, with 0-4 = no anxiety; 5-9 = mild; 10-14 = moderate; and \>15 = severe

Trial Locations

Locations (1)

30 Bee Street; 🇺🇸 Charleston, South Carolina, United States