Concept: Development and/or Validation of Devices, Electronic Systems To Monitor or Enhance Mind-Body Interventions

Project Concept Review

Council Date: June 3, 2016

Program Director: Wen G. Chen, Ph.D.

Background

The National Center for Complementary and Integrative Health (NCCIH) is committed to the rigorous investigation of mind and body interventions to determine their usefulness and safety. Mind-Body interventions (MBIs) cover a variety of procedures or techniques administered by a trained practitioner, taught by a teacher, or self-administered to improve function (e.g., improve motor control and balance), and to modulate or reduce symptoms (e.g., pain and anxiety). More about the current mind and body interventions supported by the NCCIH may be found at nccih.nih.gov/health/integrative-health.

Developing insights into biological, physiological effects and mechanisms of action of MBIs will help provide a scientific evidence base to guide clinical practice and public use. Understanding biological mechanisms will also help to refine and enhance MBIs. Examples of proposed mechanisms of MBIs include effects of MBIs on parasympathetic and sympathetic systems, recruitment of cortical and subcortical mechanisms, and activation of anti-inflammatory processes.

As underlying mechanisms of action for Mind-Body Interventions are explored, novel technologies and devices are needed to assess those mechanisms; monitor and measure intervention outcomes; and to explore methods of enhancement of Mind-Body Interventions. Technology development, electronics miniaturization, and wide use of activity- measuring consumer devices create opportunities for monitoring Mind-Body related biomarkers outside the lab.

Purpose of Proposed Initiative

The purpose of this initiative is to solicit research leading to the development of new cutting edge technologies, the adaptation of existing innovative technologies, devices and, or electronic systems, or the repurposing of existing devices and electronic systems to monitor or enhance the mechanistic processes or functional outcomes of MBIs. The proposed study should meet at least one of the following two components: 1) promoting technological development and innovation; and 2) pilot clinical testing of single or combined components of an integrated, long term, automated, wearable monitoring and/ or stimulation system, such as a device, smart clothes, personal electronics, jewelry, etc.

Objectives

Proposals are expected to target proven or putative mechanisms of Mind-Body Interventions; as well as adherence to Mind-Body practices, effectiveness of Mind-Body practitioner training, or quality of trainer-trainee interactions. Technologies, devices and electronic systems developed through this initiative are expected to be later commercialized for the researcher, clinician, or consumer markets. Free standing clinical trials for efficacy or effectiveness will not be supported through this initiative. Development of novel non-invasive or minimally invasive technologies, systems, or devices is particularly encouraged.

High program priority topic areas/clinical outcomes for this initiative include, but are not limited to:

• Pain and pain management.
• Sleep and sleep disturbances.
• Symptomatic conditions, such as those associated with menopause.
• Management of mental health conditions commonly managed in primary care such as mild to moderate depression and anxiety.
• Behavioral change to promote healthy behaviors such as healthy eating and physical exercise.

Examples of technological development and validation studies include, but are not limited to:

• Develop and pilot test devices to provide bio-feedback for MBIs such as meditation, hypnosis, other meditative interventions, or acupuncture.
• Develop and pilot test systems to enhance the emotional, cognitive, or other special components of an MBI.
• Develop and pilot test systems or devices to measure and promote adherence to the practice of MBIs such as meditation, yoga, or tai chi.
• Develop and pilot test wearable electronics that measures brain activity changes associated with various stages of meditation.
• Adapt actigraphy devices for Mind-Body movement therapies.
• Develop methods to measure heart rate parameters and blood oxygenation.
• Develop or adapt technologies for breathing monitoring.
• Develop sleep monitoring technology for an MBI.
• Develop electrodermal response for an MBI.
• Develop or adapt biochemical marker monitoring (e.g. stress) for an MBI.
• Develop or adapt wireless data collection tools for an MBI.