Biomarker Establishment for Superior Treatment of PTSD Study (BEST)

Biomarker Establishment for Superior Treatment of PTSD Study (BEST)

Biomarker Establishment for Superior Treatment (BEST)

The Challenge

Currently, there are no tools to predict treatment outcomes for PTSD. Trauma-focused psychotherapies are the most evidence-based treatments for PTSD; however, only a minority of individual with PTSD pursue this type of treatment even though not seeking psychotherapy lowers the likelihood of recovery. Knowledge that patients would likely respond to psychotherapy would encourage them to pursue treatment. Developing a test that predicts a good outcome will encourage implementing PTSD psychotherapy skills in the community, allowing more patients to seek these treatments.

Despite many years of pioneering work studying the brain’s behavior and how it functions in individuals with PTSD, the field of psychiatry lacks objective measures for understanding the many different biological effects of PTSD (i.e., sleepless nights, spontaneous moments of panic, faltering memory, poor cognition, or erratic moods). As a result, there are no reliable ways to determine who will benefit from which treatment. Moreover, PTSD is incredibly heterogeneous; groups of symptoms, which help physicians diagnose PTSD, differ widely depending on which diagnostic test is used. 

Our Goal

Establishing objective metrics to identify distinct, biological biomarkers of PTSD could provide the basis for targeted treatment and development of novel therapeutics. Additionally, grouping patients by expected response to psychotherapy can also support the use of these biomarkers as companion diagnostics in developing and testing new interventions.

Our Solution

CVB has teamed up with Stanford University to study clinical biomarkers and identify brain activity patterns – or neural signatures – in PTSD to help match patients to the most effective available treatment.

Amit Etkin, MD, PhD, Professor of Psychiatry and Behavioral Sciences at Stanford University, conducted a study to evaluate if PTSD ‘markers’ can help inform effective treatment decisions. By exploring both neural signatures of PTSD and differences in memory function using function MRI (fMRI) and cognitive tests, this study identified a novel method for disentangling the heterogeneity (variations) of PTSD by characterizing patient sub-groups. These findings provide objective evidence for predicting a patient’s response to treatment and will promote the transition from a subjective diagnosis of PTSD based on symptom report, to an objective diagnosis based on underlying biological causes. Findings from this study were recently published in the journal, Science Translational Medicine. 

What is a functional MRI (fMRI)?

Functional magnetic resonance imaging or functional MRI measures brain activity by detecting changes associated with blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases. Clinical use of fMRI still lags behind research use. Patients with brain pathologies are more difficult to scan with fMRI than are young healthy volunteers and the availability and cost of the imaging prohibits regular use.

 

What is an EEG?

An electroencephalogram (EEG) is a noninvasive test that records electrical patterns in your brain. The test is used to help diagnose conditions such as seizures, epilepsy, head injuries, dizziness, headaches, brain tumors and sleeping problems. EEG is a much more accessible and clinic-friendly form of brain imaging, adapting the biomarker discovery to an EEG would greatly enhance the use of this treatment response biomarker in routine clinical care.

Biomarker Establishment for Superior Treatment (BEST)

To expand on this study, the Biomarker Establishment for Superior Treatment (BEST)-PTSD study aims to replicate and validate these findings in a larger group of participants and translate to different types of therapy and more clinic-friendly brain imaging techniques. Through the BEST study, investigators hope to learn whether there are biological factors that can be measured before a patient starts therapy to predict their treatment response.

The BEST-PTSD study includes Veterans with PTSD who will receive either on-going cognitive processing therapy (CPT) or prolonged exposure (PE) therapy. The study will also include a control group of Veterans without PTSD to establish “normative” responses for brain and behavioral assessments.  Further, BEST seeks to translate earlier findings using functional MRI (fMRI) to a more widely accessible form of brain scanning, EEG.

The Study is set to complete at the end of 2019. If successful, this brain biomarker will be the first of its kind for PTSD and may help accelerate the pace of discovery of effective treatments, leading researchers to a path for personalized medicine approaches and matching patients with the best interventions more quickly.

Next Steps

The next steps for this program will be to develop these brain biomarkers as diagnostics tests through the FDA Center for Devices and Radiological Health (CDRH) devices program.

Impact to Veterans

The Impact for Veterans is that a Response Diagnostic Test would be a Clinical Decisions Support Tool for their doctor to use in guiding the best treatment options for them.

“Our goal is to create a brain signature specific to an individual and then tailor treatment accordingly,” says Dr. Etkin. “Ultimately, we hope to have a clinic-ready tool that will dramatically change how we care for patients with post-traumatic stress.”

“Post-traumatic stress presents in patients in myriad of ways, which underscores the need for individualizing treatment,” says Magali Haas, MD, PhD, CEO & President of Cohen Veterans Bioscience. “Our collaboration with the talented team at Stanford will lead us one step closer to understanding the mechanisms underlying PTSD in specific individuals, which is critical if we are to develop diagnostic tests that can provide accurate diagnoses, new treatments, and tools to measure the effectiveness of a given treatment.”

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