Body-focused repetitive behaviors (BFRBs), symptoms of Obsessive Compulsive Disorder (OCD) and other conditions involving compulsions (e.g., Autism Spectrum Disorder) involve compulsively causing physical injury and/or damaging one’s physical appearance. These are among the most poorly understood symptoms; they are often misdiagnosed and undertreated. BFRBs include hitting oneself, biting, pulling out hair, skin picking and cutting, as well less severe but damaging behaviors such as nail biting, thumb sucking, and nose picking (Families & Health). These symptoms affect at least 5% of the population (Families & Health); hair pulling alone affects 1%, or about 3 million people in the US (Diefenbach, Reitman & Williamson 2002). BRFBs are highly comorbid. Studies have shown that as many as 70% of those with one BRFB will have another co-occurring BRFB (Conelea, Frank & Walther, 2017). While often impairing, affecting medical health and/or disfiguring, these symptoms are frequently reported but often not observed in clinical settings. This makes diagnosis, as well as treatment planning and monitoring, exceedingly difficult. To avoid pain and disfigurement, it is imperative to identify a reliable means to automatically identify and monitor BFRBs, especially outside the clinic setting. Clinicians need data on BFRB frequency and timing for the purposes of diagnosis, treatment planning and monitoring while patients need immediate, real-time feedback to make behavioral therapies more effective.
To address this previously unmet clinical need, we have created a prototype for a wrist-worn device called the “Tingle” that can monitor and record BFRBs while also providing real-time (haptic) feedback (on the wrist) to the individual with BFRBs when they occur. The Tingle is the subject of U.S. Patent Application #15/816,706 filed January 26, 2018.
In a pilot study to establish the accuracy with which the Tingle can detect BFRBs in a controlled setting, we recruited 50 healthy, adult volunteers to wear the Tingle and repeatedly simulate 9 different behaviors (eating, smoking, thumb sucking, nail biting, nose picking, skin picking, and hair pulling from three locations). We just gathered the data and are analyzing the data now!
This proof of concept leads to the critical next step of applying the Tingle to the clinical setting in which we will confirm the Tingle’s effectiveness in preparation for an FDA New Device Application and plan for commercialization. This will open the way for broad distribution in clinical practice as a diagnostic tool and to support the evaluation and implementation of pharmacological and behavior therapies for BFRBs.
The Tingle is well-positioned to address the tremendous unmet need in the care of individuals with BFRBs and other damaging and impairing compulsive behaviors. The Tingle will revolutionize the diagnosis and treatment of at least 5% of the population affected by these severe symptoms by using a convenient, automated, unobtrusive, and inexpensive device that both records behaviors for clinical assessment and provides accurate, real-time feedback to the wearer in support of therapy. We will evaluate the Tingle wearable device to facilitate diagnosis and therapy outside the clinic. In turn, this will facilitate the more rapid commercialization of this product to make it more widely available to clinicians and their patients.
The above 3D model represents the top half of the Tingle device enclosure. By 3D printing the enclosure, we are able to precisely orient the sensors mounted inside. The holes in the model correspond to individual sensors, a button and an indicator LED.