Ultrasonic Neuromodulation for Treatment of PTSD

NCT06135064 | Terminated Phase 1

• 1 other identifier: IRB_00173062
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• National Institutes of Health Toolbox Cognitive Battery (NIHTB-CB)

  Up to 3 months following study initiation

• California Verbal Learning Test, 3rd Edition (CVLT3)

  Up to 3 months following study initiation

• PROMIS scale of Pain Intensity

  Up to 3 months following study initiation

• Hamilton Depression Rating Scale (HDRS-17)

  Up to 3 months following study initiation

• Pittsburgh Sleep Quality Index (PSQI)

  Up to 3 months following study initiation

Study Arms (2)

Active stimulation

EXPERIMENTAL

Low-intensity transcranial focused ultrasound stimulation of deep brain targets affected by PTSD.

Device: Diadem

Sham stimulation

SHAM COMPARATOR

Sham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses.

Device: Diadem

Interventions

Diadem DEVICE

The device delivers low-intensity ultrasonic waves into specified brain targets.

Active stimulation; Sham stimulation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive PTSD diagnosis; PCL-5 \> 20

You may not qualify if:

• Inability to complete MRI
• Suicidal ideation

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84103, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jan Kubanek, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Elisabeth Wilde, PhD

  University of Utah

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 18, 2023
• Study Start: April 5, 2024
• Primary Completion: September 27, 2024
• Study Completion: September 27, 2024
• Last Updated: May 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)