Ultrasonic Neuromodulation for Treatment of PTSD

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06135064
• Other study ID #: IRB_00173062
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: April 2024
• Est. completion date: April 2027

Study information

• Verified date: November 2023
• Source: University of Utah
• Contact: Jan Kubanek, PhD
• Phone: 801-213-1418
• Email: jan.kubanek[@]utah.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Positive PTSD diagnosis; PCL-5 > 20

Exclusion Criteria:

• Inability to complete MRI

• Suicidal ideation

Related Conditions & MeSH terms

• PTSD

Intervention

Device:
• Diadem
The device delivers low-intensity ultrasonic waves into specified brain targets.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Utah

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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