Low-Intensity Focused Ultrasound for Treatment-Resistant Depression

Sponsor

Medical University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06013384

Collaborator

Dart Therapeutics. LLC (Other)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder Treatment Resistant Depression	Device: Low-Intensity Focused Ultrasound Pulsation	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Clinical Feasibility of Low Intensity Focused Ultrasound Pulsation for the Treatment of Treatment Resistant Major Depressive Disorder

Anticipated Study Start Date :

Oct 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active/Active Group 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 Low-intensity focused ultrasound pulsation will be directed towards the target region at FDA-approved intensity levels to determine its efficacy for major depression.
Other: Sham/Active Group 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 Low-intensity focused ultrasound pulsation will be directed towards the target region at FDA-approved intensity levels to determine its efficacy for major depression.

Arm

Intervention/Treatment

Experimental: Active/Active Group

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

Low-intensity focused ultrasound pulsation will be directed towards the target region at FDA-approved intensity levels to determine its efficacy for major depression.

Other: Sham/Active Group

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

Low-intensity focused ultrasound pulsation will be directed towards the target region at FDA-approved intensity levels to determine its efficacy for major depression.

Outcome Measures

Primary Outcome Measures

MADRS Score Reduction [One week post-treatment]
Reduction in MADRS score

Secondary Outcome Measures

PHQ-9 Score Reduction [One week post-treatment]
Reduction in PHQ-9 Score
GAD-7 Score Reduction [One week post-treatment]
Reduction in GAD-7 Score

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria:

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

Exclusionary criteria:

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.
Inability to adhere to treatment schedule.
Initiation of new antidepressant treatment at the time of study randomization.