Ultrasonic Neuromodulation for Treatment of PTSD

Deep Brain Therapy With Low-intensity Ultrasound for Treatment of Post-traumatic Stress Disorder

This study will evaluate a new form of non-invasive deep brain therapy for individuals with post-traumatic stress disorder (PTSD). Low-intensity transcranial focused ultrasound stimulation will first be delivered using a range of stimulation parameters during psychophysical and physiological monitoring. A well-tolerated stimulation protocol will be selected for subsequent testing in a blinded randomized sham-controlled cross-over trial. The trial will evaluate brain target engagement using magnetic resonance imaging and numerical scales of PTSD, cognitive performance, and mood.

Study Overview

• Status: Terminated
• Conditions: PTSD
• Intervention / Treatment: Device: Diadem

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84103
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Positive PTSD diagnosis; PCL-5 > 20

Exclusion Criteria:

• Inability to complete MRI
• Suicidal ideation

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham stimulation; Sham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses.	Device: Diadem; The device delivers low-intensity ultrasonic waves into specified brain targets.
Experimental: Active stimulation; Low-intensity transcranial focused ultrasound stimulation of deep brain targets affected by PTSD.	Device: Diadem; The device delivers low-intensity ultrasonic waves into specified brain targets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PTSD Checklist for DSM-5 (PCL-5)	20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD. The total severity scores range from 0 to 80.	Up to 3 months following study initiation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Depression Rating Scale (HDRS-17)	This 17-item questionnaire rates the severity of depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The scores range from 0 (no symptoms) to 52 (worst possible).	Up to 3 months following study initiation
National Institutes of Health Toolbox Cognitive Battery (NIHTB-CB)	The NIHTB-CB provides the following summary scores: Total Cognition Composite, Fluid Composite (includes Dimensional Change Card Sort, Flanker Inhibitory Control and Attention, Picture Sequence Memory (Form A), List Sorting Working Memory, and Pattern Comparison tests), and Crystallized Composite (includes Picture Vocabulary and Oral Reading Recognition tests). The scores are normalized to have a mean score of 10 and standard deviation of 3.	Up to 3 months following study initiation
California Verbal Learning Test, 3rd Edition (CVLT3)	A verbal learning and memory test designed to test immediate recall, short delay recall, long delay recall, and recognition memory, as well as the memory strategies being used by the participant. The Brief Form of the CVLT 3 consists of nine words, administered repeatedly over 4 immediate recall trials. The scoring software provides normative data.	Up to 3 months following study initiation
PROMIS scale of Pain Intensity	The score assess the worst, average, and current levels of pain on a scale from 1 (no pain) to 5 (very severe)	Up to 3 months following study initiation
Pittsburgh Sleep Quality Index (PSQI)	Test consisting of 7 components summed to yield a global PSQI score, ranging from of 0 (good sleep) to 21 (poor sleep).	Up to 3 months following study initiation

Collaborators and Investigators

• Sponsor: University of Utah
• Investigators: Principal Investigator: Jan Kubanek, PhD, University of Utah; Study Chair: Elisabeth Wilde, PhD, University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2024
• Primary Completion (Actual): September 27, 2024
• Study Completion (Actual): September 27, 2024

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 11, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IRB_00173062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No