ACLARIS MEDICAL LLC — Department of Health and Human Services SBIR Phase I: 102

Description

DESCRIPTION provided by applicant Posttraumatic stress disorder PTSD affects of American adults over their lifetime and is estimated to cost the US over $ billion per year Prolonged Exposure PE is one of the most effective treatments for PTSD but under engagement poor adherence and dropout limit recovery for many patients Improved tracking and feedback of engagement level homework adherence and measures indicating dropout risk would help therapists modify treatment reinforce progress and motivate patients to continue therapy Unfortunately current methods of clinical evaluation i e structured interviews and questionnaires are insufficient as they are subjective relatively infrequent e g weekly and dependent on the patientandapos s self report accuracy and motivation The addition of objective physiologic data could yield a more comprehensive assessment of engagement and treatment response While physiologic monitoring devices exist they are too complex and cumbersome lack the needed parameters and sensitivity and have not been developed for use with PE A PTSD specific solution is needed that can integrate relevant physiologic and psychometric data to better assess treatment effects and improve patient acceptance engagement and adherence To solve this problem Aclaris Medical LLC Aclaris is teaming with the Center for the Treatment and Study of Anxiety CTSA and a world class group of clinical scientific and human factors usability advisors to demonstrate the feasibility of a novel monitoring system to advance PE for PTSD patients When developed this product will utilize physiologic data collected by Aclarisandapos s Autonomic Wrist Monitor AWM psychometric data collected by the companyandapos s Therapist App and ecological momentary assessment EMA data collected by the companyandapos s Patient App The collected data will be integrated for display in the Therapist App to help the therapist assess engagement homework adherence and dropout risk so they can intervene before it is too late Preliminary data from Aclaris sets the stage for successfully meeting the Phase I aims to demonstrate feasibility Aim Prove Feasibility of Therapist App and Patient App Aim Prove Feasibility of AWM during PE Aim Prove Feasibility of PTSD Monitoring System At the end of Phase I the company expects to achieve a functional prototype of the PTSD Monitoring System an assessment of its feasibility and insight on how to best deploy it for use with PE In Phase II Aclaris will further develop the monitoring system and conduct a larger study with PTSD patients at CTSA comparing conventional PE to PE enhanced with the PTSD Monitoring System Phase II success will provide the data needed to approach the Department of Veterans Affairs and Department of Defense for a larger multi center pilot evaluation and attract additional private investment for FDA approval and civilian commercialization Beyond PTSD the company plans to expand the use of the platform to research and treat other mental health disorders and conditions e g phobias panic disorder social anxiety disorder and common stress as well as chronic medical conditions affecting the autonomic nervous system PUBLIC HEALTH RELEVANCE Current treatments for posttraumatic stress disorder PTSD such as prolonged exposure therapy have demonstrated effectiveness but many patients dropout or do not engage with exposures Technology is needed that can help therapists assess patient engagement level homework compliance and dropout risk so they can intervene before it is too late The overall goal of this multi phase SBIR project is to develop validate and commercialize a PTSD Monitoring System that integrates psychometric data with physiologic data from a wrist worn monitor to help therapists guide treatment more effectively and better motivate patients to continue and remain engaged in therapy