Ultrasound Therapy for PTSD

Recruiting in Palo Alto (17 mi)

Overseen by Jan Kubanek, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: University of Utah

Disqualifiers: Inability to complete MRI, Suicidal ideation

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Diadem, Low-Intensity Transcranial Focused Ultrasound Stimulation, Ultrasonic Neuromodulation for PTSD?

Research suggests that non-invasive brain stimulation, like the one used in Diadem, may help improve treatments for PTSD by enhancing brain activity. Additionally, focal brain stimulation has shown potential as a treatment for PTSD, indicating that similar methods could be effective. ^{1 2 3 4 5}

How is the treatment Diadem different from other PTSD treatments?

Diadem, or Low-Intensity Transcranial Focused Ultrasound Stimulation, is unique because it uses sound waves to target specific areas of the brain non-invasively, unlike traditional treatments that often involve medication or more invasive procedures. This approach is part of a new wave of neuromodulation therapies that aim to alter brain activity without surgery. ^{1 2 4 6 7}

Eligibility Criteria

This trial is for individuals with a confirmed diagnosis of PTSD, indicated by a score greater than 20 on the PCL-5 assessment. It's not suitable for those who don't meet this specific diagnostic threshold.

Inclusion Criteria

You have been diagnosed with PTSD and your PCL-5 score is higher than 20.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Stimulation and Monitoring

Low-intensity transcranial focused ultrasound stimulation delivered with various parameters during psychophysical and physiological monitoring

4 weeks

Multiple visits for stimulation and monitoring

Blinded Randomized Sham-Controlled Cross-Over Trial

Testing of a well-tolerated stimulation protocol in a blinded randomized sham-controlled cross-over trial

8 weeks

Regular visits for treatment and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Diadem (Other)

Trial Overview The study is testing 'Diadem', which uses low-intensity focused ultrasound to stimulate the brain non-invasively in people with PTSD. The effectiveness will be measured through MRI scans and assessments of PTSD severity, cognitive function, and mood changes.

Participant Groups

Group I: Active stimulation Experimental Treatment 1 Intervention

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

Group II: Sham stimulation Placebo Group 1 Intervention

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

University of Utah Salt Lake City, UT

Who Is Running the Clinical Trial?

University of Utah Lead Sponsor

References

1. United States pubmed.ncbi.nlm.nih.gov

Combined transcranial direct current stimulation with virtual reality exposure for posttraumatic stress disorder: Feasibility and pilot results. [2021] Facilitating neural activity using non-invasive brain stimulation may improve extinction-based treatments for posttraumatic stress disorder (PTSD).

2. United States pubmed.ncbi.nlm.nih.gov

Defining focal brain stimulation targets for PTSD using neuroimaging. [2022] Focal brain stimulation has potential as a treatment for posttraumatic stress disorder (PTSD). In this review, we aim to inform selection of focal brain stimulation targets for treating PTSD by examining studies of the functional neuroanatomy of PTSD and treatment response. We first briefly review data on brain stimulation interventions for PTSD. Although published data suggest good efficacy overall, the neurobiological rationale for each stimulation target is not always clear.

3. United States pubmed.ncbi.nlm.nih.gov

Post-traumatic stress disorder. [2007] In the past few years, there has been a growing interest in the neurobiology of PTSD. A number of models have been proposed including possible structural changes. We have now seen the appearance in the literature of controlled and double-blind trials. Of interest are positive outcome studies associated with the use of drugs with serotonergic actions for a period of 8 weeks. Symptom relief provided by pharmacotherapy enables the patient to participate more thoroughly in individual, behavioral, or group therapy.

4. United States pubmed.ncbi.nlm.nih.gov

An Overview of Translationally Informed Treatments for Posttraumatic Stress Disorder: Animal Models of Pavlovian Fear Conditioning to Human Clinical Trials. [2021] Posttraumatic stress disorder manifests after exposure to a traumatic event and is characterized by avoidance/numbing, intrusive symptoms and flashbacks, mood and cognitive disruptions, and hyperarousal/reactivity symptoms. These symptoms reflect dysregulation of the fear system likely caused by poor fear inhibition/extinction, increased generalization, and/or enhanced consolidation or acquisition of fear. These phenotypes can be modeled in animal subjects using Pavlovian fear conditioning, allowing investigation of the underlying neurobiology of normative and pathological fear. Preclinical studies reveal a number of neurotransmitter systems and circuits critical for aversive learning and memory that have informed the development of therapies used in human clinical trials. In this review, we discuss the evidence for a number of established and emerging pharmacotherapies and device-based treatments for posttraumatic stress disorder that have been developed via a bench to bedside translational model.

5. Hungary pubmed.ncbi.nlm.nih.gov

[Posttraumatic stress disorder (PTSD)]. [2022] The diagnosis of posttraumatic stress disorder (PTSD) has been introduced in 1980. The diagnosis, as construct raises several political, moral, legal, and compensation issues. PTSD is considered as a multisystemic dysregulation, involving the hypothalamic- pituitary - adrenal axis, adrenergic hypersensibility, and serotonergic dysfunction. The prevalence of PTSD is 1-9% in the general population, but substantially higher among victims of traumatic events: 19-70%. Placebo controlled studies provide a body of evidence concerning efficacy of selective serotonin reuptake inhibitors in the treatment of PTSD both in the acute and maintenance treatments. Studies with balanced male-female ratio suggest no gender-related differences in the clinical response, furthermore both civilians and veterans improved significantly for selective serotonin reuptake inhibitor treatment.

6. China pubmed.ncbi.nlm.nih.gov

[Effects of 40 Hz multisensory stimulation on trauma-induced anxiety-like behavior in rats]. [2023] To investigate the effects of 40 Hz acousto-optical stimulation on anxiety like symptoms of post-traumatic stress disorder (PTSD), with emphasis on the possible molecular mechanism stimulation.

7. England pubmed.ncbi.nlm.nih.gov

Neuromodulatory treatments for post-traumatic stress disorder (PTSD). [2019] Electroconvulsive therapy has been used successfully in some individuals with posttraumatic stress disorder (PTSD) whose symptoms have not improved with other treatments. But there are only a few reports. Meanwhile, an array of new neuromodulation strategies, including repetitive transcranial magnetic stimulation, transcranial direct current stimulation, vagus nerve stimulation, trigeminal nerve stimulation, and deep brain stimulation have been developed and applied experimentally in the treatment of other psychiatric disorders. This article will review the clinical evidence and mechanistic basis for their use in PTSD.