Development and/or Validation of Devices or Electronic Systems to Monitor or Enhance Mind and Body Interventions (R41/R42)

This Funding Opportunity Announcement (FOA) supports Small Business Technology Transfer (STTR) grant applications from small business concerns (SBCs) that will develop and/or validate devices or electronic systems that can: 1) monitor biologically- or behaviorally-based processes applicable to mind and body interventions or 2) be used to assist in optimizing the practice or increasing the efficacy of mind and body interventions.  The applications should: 1) lead to the development of new technologies, 2) adapt existing innovative technologies, devices and/or electronic systems, 3) repurpose existing devices and electronic systems, or 4) conduct testing of single or combined components of an integrated, long term, automated, wearable monitoring, stimulation device or electronic system in order to monitor or enhance the mechanistic processes or functional outcomes of mind and body interventions. For the purposes of this FOA, mind and body interventions are defined as non-pharmacological approaches that include mind/brain focused interventions (e.g., meditation, hypnosis), body-based approaches (e.g., acupuncture, massage, spinal manipulation/mobilization), or combined mind and body meditative movement approaches (e.g., yoga, tai-chi, qigong).  

Studies of mind and body interventions typically comprise three key elements.  The first key element is the intervention itself, which commonly contains complex procedures or techniques administered by a trained practitioner, taught by a teacher, or self-taught or administered to improve function and/or to modulate or reduce symptoms. (More about the current mind and body interventions commonly supported by the NCCIH can be found at http://nccih.nih.gov/health/integrative-health).  The second key element is the underlying biological or behavioral process by which a given mind and body intervention may exert its intended functional change or clinical outcome.  The mechanism(s) or process(es) may range widely from biochemical/molecular processes to behavior change.  Commonly studied mechanisms of action for mind and body interventions include structural and/or functional changes of physiological systems and networks including parasympathetic and sympathetic neural systems, cortical and subcortical neural networks, neuromuscular systems, the vascular and lymphatic systems or anti-inflammatory processes.  The third key element is the intended functional or clinical outcome for the intervention.  Currently, the NCCIH mind and body intervention research focuses on functional behavior change and clinical outcomes related to:

• pain management
• improving sleep and reducing sleep disturbances
• reducing symptomatic conditions, such as those associated with menopause
• improving management of mental health conditions commonly managed in primary care such as mild to moderate depression or anxiety
• adopting and sustaining healthy behaviors such as healthy eating, smoking cessation, and physical activity

The ultimate goal of many studies of mind and body interventions is to optimize their methods and delivery to maximize efficacy.  Such a goal may be accomplished through technological innovation to monitor and possibly facilitate relevant underlying processes associated with these interventions. 

Examples of research topics of interest under this FOA relevant to a given mind and body intervention (MBI) may include, but are not limited to:

• Development and/or pilot testing of devices to provide bio-feedback or for optimizing practice
• Development and/or pilot test wireless technologies for real-time data collection and monitoring of brain activity or other physiological signals
• Development or adapt biochemical or epigenetic monitoring devices
• Development of electrodermal monitors 
• Optimize and pilot test an MBI's components or parameters to enhance its effect on a proposed mechanism or biological process
• Develop or adapt technologies to monitor or help optimize breathing for an MBI (e.g., yoga)
• Adapt actigraphy devices for an MBI 
• Develop sleep monitoring technology
• Develop or adapt technologies for objective assessment of pain
• Adapt or develop technologies for home-based delivery of an MBI
• Develop and/or pilot test systems or devices to measure and promote adherence to the practice of an MBI

This FOA primarily supports research on the types of mind and body interventions listed on the NCCIH website (http://nccih.nih.gov/health/integrative-health). 

Proposed technologies, devices or electronic systems are expected to target proven or putative mechanisms of an MBI, adherence to MBI practices, or quality of trainer-trainee interactions or other aspects of the approach to either monitor or enhance its effect.  A goal of the research should be the commercialization of technology for use by researchers, clinicians, or consumers. Development or adaptation of innovative non-invasive technologies or minimally invasive technologies is preferred.

Devices and technologies developed with the support of this FOA may be targeted for the use across the lifespan (children, adolescent's, adults and elderly), special populations, (e.g., pregnant mothers, individuals with disabilities) and for a range of social contexts (individual, family, exercise groups, classroom). 

Preclinical testing studies of the proposed technology, device, or electronic system may concentrate on healthy animals or relevant animal models for the clinical outcomes of a high program priority to the NCCIH as described earlier in the section above. 

Pilot clinical testing of the proposed technology, device, or electronic system should test their effects on presumed mechanisms or processes as the primary outcomes, and may target healthy populations, or a clinical population of high program priority for NCCIH (please see the listing of NCCIH high program priority clinical outcomes in the section above).  NCCIH will not support clinical trials aiming to test efficacy/effectiveness (meaning the study is powered on a primary outcome that is a clinical assessment, such as pain, depression, anxiety, etc.) of an intervention as a part of STTR phase I application. 

If a device is proposed as part of a pilot clinical testing, investigators must contact the US Food and Drug Administration (FDA), prior to submitting an application, to determine if an Investigational Device Exemption (IDE) application is necessary for the proposed clinical research.

See Section VIII. Other Information for award authorities and regulations.