Low-Intensity Focused Ultrasound for Treatment-Resistant Depression

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013384
• Other study ID #: Pro00128763
• Status: Recruiting
• Phase: N/A
• Start date: February 16, 2024
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Medical University of South Carolina
• Contact: Charles Palmer, MD
• Phone: 8436979989
• Email: palmecha[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: June 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depressive Disorder
• Treatment Resistant Depression

Intervention

Device:
• Low-Intensity Focused Ultrasound Pulsation
Low-intensity focused ultrasound pulsation will be directed towards the target region at FDA-approved intensity levels in treatment sessions one and two.
• Sham Low-Intensity Focused Ultrasound Pulsation
Sham low-intensity focused ultrasound pulsation will be given.

Locations

Country	Name	City	State
United States	30 Bee Street	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

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