Low-Intensity Focused Ultrasound for Treatment-Resistant Depression

February 16, 2024 updated by: Charles Palmer, Medical University of South Carolina

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Recruiting
        • 30 Bee Street
        • Contact:
          • Charlie Palmer, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 in treatment sessions one and two.
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 in treatment sessions one and two.
Device: Sham Low-Intensity Focused Ultrasound Pulsation
Sham low-intensity focused ultrasound pulsation will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Montgomery-Asberg Depression Rating Scale (MADRS) Score Change
Time Frame: 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
One week post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire (PHQ-9) Score Change
Time Frame: 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
One week post-treatment
General Anxiety Disorder (GAD-7) Score Change
Time Frame: 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
One week post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

Dart Therapeutics. LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

August 22, 2023

First Submitted That Met QC Criteria

August 22, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00128763

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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