Focused Ultrasound for PTSD in Veterans

ConditionPosttraumatic Stress Disorder

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age22-70

SponsorVA Office of Research and Development

About this trial

The goal of this study is to develop a new, non-invasive brain stimulation modality called low intensity focused ultrasound (FUS) as a psychiatric rehabilitation treatment for posttraumatic stress disorder (PTSD). FUS delivers energy comparable to that involved in diagnostic ultrasound but in a millimeter-sized envelope. Unlike currently available methods, the maximal FUS energy is delivered at a distance from a transducer on the scalp. Therefore, its promise is that it can deliver focal and reversible modulation to deeper brain regions involved in PTSD. The investigator team has previously conducted first-in-human research in FUS, and this study builds upon that work to conduct a phase II, dose-finding study. This study will pursue two Aims; the first is whether FUS to the amygdala can improve symptoms, and the second will evaluate whether FUS improves function by reduced disability, over a 1-month period. Short and longer-term effects of FUS will be measured and all FUS parameters are within FDA-defined safety thresholds for diagnostic ultrasound.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

i) history of seizure disorder or serious neurologic illness including dementia or serious cognitive impairment,

ii) structural or neurologic abnormalities present or in close proximity to sonication site

iii) prior brain surgery

iv) pacemaker or implanted central nervous system device

Trial design

Design model

Parallel

Treatments tested in this trial

Brainsonix Ultrasound Device
Device
This device delivers low intensity focused ultrasound and delivers either active or sham sonication depending upon the transducer pad used.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: Verum low intensity focused ultrasoundActive comparator 1 intervention

Group B: Sham low intensity focused ultrasoundSham comparator 1 intervention

Trial outcomes

Primary outcomes

Post-traumatic stress disorder (PTSD) Checklist for DSM5

The PTSD Checklist for Diagnostic and Statistical Manual-5 (PCL-5) is a gold standard self reported scale of PTSD symptoms. Scores range from 0-80, where higher scores indicate greater symptom severity. The Week 5 visit value is the primary outcome measure of the study.

Time frame

Up to 3 months

Secondary outcomes

Sheehan Disability Scale

The Sheehan Disability Scale (SDS) is a self report tool used to assess functional impairment in work, social and family life. Scores range from 0-30, where higher scores indicate greater impairment.

Time frame

Up to 3 months

Social and Occupational Function Scale

The Social and Occupational Function Scale (SOFAS) assesses social and occupational function, and is scored from 0-100, where higher scores indicate superior (better) social and occupational function.

Time frame

Up to 3 months

Inventory of Depressive Symptoms Self Report

The Inventory of Depressive Symptoms, Self-Report (IDSSR) is a rating scale that measures self-reported depressive symptoms. Scores range from 0-84, where higher scores indicate more severe depressive symptom severity.

Time frame

Up to 3 months

Clinician Administered PTSD Scale

The Clinician Administered Posttraumatic Stress Disorder Scale for Diagnostic and Statistical Manual-5 (CAPS-5) is structured clinical interview for posttraumatic stress disorder symptoms. Scores range from 0-80, where higher symptoms indicate more severe symptom severity.

Time frame

Up to 3 months

Other outcomes

Visual Analog Scale

The visual analog scale assesses global symptom burden and is assessed immediately after ultrasound administration. Scores are rated on a visual scale from 0 to 100 where 100 is the maximum global burden.

Time frame

Three times per week for up to five weeks

Arterial Spin Labeling/fMRI

Functional magnetic resonance imaging measures are assessed prior to and following all focused ultrasound procedures.

Time frame

Five weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov

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