Ultrasonic Neuromodulation for Treatment of PTSD

Utah System of Higher Education (USHE)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: PTSD

Treatments: Device: Diadem

Study type: Interventional

Funder types: Other

Identifiers

NCT06135064

IRB_00173062

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive PTSD diagnosis; PCL-5 > 20

Exclusion criteria

• Inability to complete MRI
• Suicidal ideation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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10 participants in 2 patient groups

Active stimulation

Experimental group

Description:

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

Treatment:

Device: Diadem

Sham stimulation

Sham Comparator group

Description:

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

Treatment:

Device: Diadem