Ultrasonic Neuromodulation for Treatment of PTSD

Phase 1

Suspended

• Conditions: PTSD
• Interventions: Device: Diadem

• Registration Number: NCT06135064
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-11
• Study First Posted: 2023-11-18
• Study Start: 2024-04-05
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-24
• Last Update Posted: 2025-04-29
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Positive PTSD diagnosis; PCL-5 > 20

Exclusion Criteria

• Inability to complete MRI
• Suicidal ideation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active stimulation	Diadem	Low-intensity transcranial focused ultrasound stimulation of deep brain targets affected by PTSD.
Sham stimulation	Diadem	Sham stimulation that applies the device in the same way as verum but only delivers auditory sounds correspoding to the ultrasonic pulses.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
California Verbal Learning Test, 3rd Edition (CVLT3)	Up to 3 months following study initiation	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.
National Institutes of Health Toolbox Cognitive Battery (NIHTB-CB)	Up to 3 months following study initiation	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.
PROMIS scale of Pain Intensity	Up to 3 months following study initiation	The score assess the worst, average, and current levels of pain on a scale from 1 (no pain) to 5 (very severe)
Hamilton Depression Rating Scale (HDRS-17)	Up to 3 months following study initiation	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).
Pittsburgh Sleep Quality Index (PSQI)	Up to 3 months following study initiation	Test consisting of 7 components summed to yield a global PSQI score, ranging from of 0 (good sleep) to 21 (poor sleep).

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States