SBIR-STTR Award

The proposed research will develop a wearable awareness enhancement and monitoring device (AEMD) which will assist the treatment of trichotillomania, a repetitive hair pulling disorder that leads to noticeable hair loss. The device will monitor relative body position between the hand and the effected hair, creating awareness by signaling the user, using vibration and/or sound, prior to pulling. The device will have monitoring capabilities which will allow for users to classify the nature of each hand to body touching incident as a hair pull, a near pull, or as an incidental touch. These incidents and their classification will be logged with a time and date stamp and downloaded to a personal computer for analysis and graphic presentation. The device can function with both the alert and monitoring features activated or it can simply monitor behaviors without the alarm feature. The proposed Phase I device is a small signaling mechanism which will have triggering elements worn near the head, elements containing a sensor and Bluetoothtm RF communication worn on or near the hands, and an alarm, Bluetoothtm RF communication and data logging element (a Bluetoothtm enabled commercially available personal data assistant - PDA) worn at the waist or in a pocket. During Phase I, prototypes will be developed and tested for size, weight and battery life, the ability to signal at programmed distances/durations between the hand and head, and for other functions. It will be non-responsive to incidental RF interference, signaling only when the trigger enters the alarm zone. The device has a user-adjustable time delay feature. Users who wish earliest possible habit interruption can select a no delay option whereas those who are sensitive to "false alarms" can set a customized time delay before the device triggers an alert. The device will allow the user to activate a temporary time-off feature allowing for non-destructive hand to head functions (e.g. tooth brushing). Prototypes will be tested on nine human subjects in Phase I. In Phase II, the technology will continue to be developed for miniaturization and manufacturability and we will extend this body of research with human studies conducted on individuals with trichotillomania to determine the efficacy of the device. Research to date suggests that medications and behavior therapy, while helpful, leave many individuals with clinically significant hair pulling and in need of further help. The initial commercial application of the device will be aimed at the 1.8 million plus individuals with trichotillomania in the United States, and it is expected be used in conjunction with existing behavioral therapies. In addition to offering a new treatment for trichotillomania, the proposed device, or modified versions, could be used to help treat other body-focused repetitive behavior problems such as skin picking, finger and nail biting. The goal of the proposed research is to develop a device to assist persons with trichotillomania, a very impairing, commonly undiagnosed and untreated problem involving compulsive hair pulling. This device will help sufferers gain awareness of their hair pulling and will also monitor the frequency and duration of this destructive habit. Available psychological treatments are only partially helpful and this device when integrated with current treatments could substantially improve the lives of sufferers and their families.

Thesaurus Terms:
awareness, biomedical equipment development, hair, miniature biomedical equipment, monitoring device, obsessive compulsive disorder, portable biomedical equipment biomedical device power system, hand, limb movement, personal computer clinical research, human subject, questionnaire

The goal of the proposed research is to further refine and evaluate an inconspicuous, awareness- enhancement and monitoring device (AEMD) which will assist the treatment of trichotillomania (TTM). TTM is associated with significant impairments in social functioning and often has a profound negative impact on self- esteem and well being. Conservative estimates suggest that 0.6% percent of the US population, or about 1.8 million people, meet full diagnostic criteria for TTM and approximately 7.5 million US residents have significant hair pulling problems. Of those treated, 60% to 70% are wholly or partially refractory to standard behavioral and pharmacological treatments and could therefore potentially benefit from this device. Best practice treatment for TTM involves a form of behavioral therapy known as habit reversal therapy (HRT). HRT requires persons with TTM to be aware of their hair pulling behaviors, yet the majority of persons with TTM pull most of their hair outside of their awareness. HRT also requires TTM sufferers to record the frequency and duration of their hair pulling behaviors yet it is impossible for a person to monitor behaviors that they are unaware of. Our Phase I efforts have produced a prototype device (AEMD) that solves these two problems. The prototype AEMD signals the TTM sufferer if their hand approaches their hair, thereby bringing pulling-related behavior into awareness. The prototype AEMD also logs the time, date, duration, and user classification of hair pulling related events. Our published pilot study and subsequent investigations establish that the prototype AEMD successfully alerts TTM sufferers to pulling-related behaviors and monitors TTM-related behavior in a laboratory setting. With respect to technological innovation, this project has the potential to develop the first available miniaturized, wearable, patient interactive, real-time data collecting and proximity-sensing device that both alerts sufferers to the presence of mental illness symptoms as they occur and keeps track of the frequency and intensity of the problem. The patented technologies developed for the AEMD have the potential to be of great value for a range of other health/mental health conditions or industrial applications. Our overall Phase II aim is to further refine the AEMD and to evaluate its acceptance and utility when used in an open trial course of professionally-led habit reversal therapy. It is hypothesized that the AEMD will be enthusiastically accepted by TTM sufferers and their clinicians and that it will perform as designed during the clinical trial. The Phase II AEMD will include a bracelet(s)/watch to be worn on each wrist, another element to be placed at the rear base of the neck, and a pager-like alert device to be worn at the belt-line or in a pocket. The AEMD, if found to be useful and effective, has the potential to significantly reduce the symptoms of TTM and its associated functional impairments. The AEMD also has great potential to improve assessment and monitoring of TTM behaviors which could be invaluable to clinicians planning treatment and to researchers evaluating the efficacy of various treatment strategies.

Public Health Relevance:
This Phase II project involves continued design, development and evaluation of a device that aids in the treatment of trichotillomania. The device enhanced awareness of pulling behavior and monitors this disabling condition.

Thesaurus Terms:
"awareness; Awarenesses; Behavior; Behavior Conditioning Therapy; Behavior Modification; Behavior Therapy; Behavior Treatment; Behavior Monitoring; Behavior Or Life Style Modifications; Behavioral; Behavioral Conditioning Therapy; Behavioral Modification; Behavioral Therapy; Behavioral Treatment; Benign; Cell Communication And Signaling; Cell Signaling; Classification; Clinic; Clinical; Clinical Trials; Clinical Trials, Unspecified; Code; Coding System; Computer Analysis; Conditioning Therapy; Coughing; Data; Data Collection; Development; Device Designs; Devices; Diagnosis; Diagnostic; Disease; Disorder; Emf; Electromagnetic Fields; Elements; Evaluation; Event; Frequencies (Time Pattern); Frequency; Functional Impairment; Future; Goals; Government; Habits; Hair; Hand; Head; Head Movements; Home; Home Environment; Hour; Impairment; Intracellular Communication And Signaling; Investigation; Investigators; Laboratories; Legal Patent; Life; Life Style Modification; Mental Health; Mental Hygiene; Mental Disorders; Mental Health Disorders; Miniaturisations; Miniaturization; Miniaturizations; Monitor; Neck; Patents; Patients; Pattern; Personal Computers; Persons; Pharmacological Treatment; Phase; Pilot Projects; Population; Psychiatric Disease; Psychiatric Disorder; Psychological Health; Publishing; Radiation, Electromagnetic Fields; Randomized Controlled Trials; Recurrence; Recurrent; Refractory; Research; Research Personnel; Researchers; Signal Transduction; Signal Transduction Systems; Signaling; Social Functioning; Symptoms; System; System, Loinc Axis 4; Systematics; Technology; Testing; Time; Toothbrushing; Touch; Touch Sensation; Trichotillomania; Unspecified Mental Disorder; Wrist; Base; Behavior Intervention; Behavioral Intervention; Biological Signal Transduction; Clinical Investigation; Computational Analysis; Design; Designing; Disease/Disorder; Efficacy Trial; Electromagnetic Field; Falls; Functional Disability; Impression; Improved; Magnetic Field; Meetings; Mental Illness; Miniaturize; Monitoring Device; Pilot Study; Prototype; Psychological Disorder; Public Health Relevance; Randomized Controlled Study; Self Esteem; Sensor; Success; Technological Innovation; Tooth Brushes; Tooth Brushing; Toothbrush; Treatment Effect; Treatment Planning; Treatment Strategy"