Overview:

NASA is seeking non-invasive, portable technologies to measure intra-cranial pressure (ICP) for use in humans while in space and on the ground. Direct measure of ICP is not necessary if there is a provable correlation between the measurement being taken and an absolute value of ICP. Solutions need to be fully developed with clinical data showing quantifiable, repeatable measurements and be ready for testing, preferably in the next 1-2 years.

Background:

Manned spaceflight imposes unknown stresses on the human body. For example, some astronauts have been found to have impaired vision after experiencing extended periods of micro-gravity. One hypothesis is that alterations in intra-cranial pressure are responsible for these and other physiological manifestations experienced in space. NASA needs a monitoring system to test this hypothesis.

NASA is seeking fully-developed, non-invasive, portable technologies for intra-cranial pressure (ICP) measurement on the ground and in space.

Constraints:

Technologies should either currently meet these constraints or have a reasonable expectation of meeting similar constraints within 1-2 years.

  • Technology must be portable and non-invasive, with quantifiable, repeatable measurements.
  • The solution must be in the technology verification stage or beyond with clinical data.
  • Technology must operate independent of gravity and acceleration.
  • Preference for devices that do not require invasive measurements to establish a baseline or calibration for every use (especially during flight), although invasive calibration at baseline on the ground before flight is acceptable. Therefore, if the units of the noninvasive device are not in units of pressure, a pressure value could be calculated so that noninvasive measures could be compared to typical clinical ICP units of measure (for example, mmHg or cmH20).
  • Preference for smaller devices, but larger devices that could be miniaturized will also be considered.
  • The proposed miniaturized/portable solution does not have to meet current hospital-level diagnostic standards, but it must be safe for human use (FDA approval preferred, plan for FDA approval acceptable).
  • Conventional hospital-setting equipment, instrumentation intended to be miniaturized, and for-medical-care applications by trained but non-medical personnel for use in remote environments will also be considered.
  • Preference for technologies that: minimize mass, power, and volume; minimize training and operational time required to use the device; utilize materials and designs to operate in space flight environments including high radiation exposure; minimize emission of waste material during operation such as waste gas.
  • Additional desirables for solutions include a device that outputs a continuous data waveform, providing ICP pulse waveform information (for example, ICP pulse height and frequency content). In addition, preferred solutions include those devices that can reproducibly detect a change in ICP of approximately four mmHg.

Possible Solution Areas:

Hospital equipment, medical equipment providers, medical and university research. Specific areas of interest may include: Non-invasive BPM, Brainstem Auditory Evoked Potentials, Cerebral blood flow velocity, Electronic pulsed phase locked loop (PPLL), Head Resonance, Ophthalmodynamometry (ODM), Transcranial Doppler & ABP amongst others.

Desired outcome of the solution:

Ideally, NASA will find technology ready for testing on the ground and in-flight launch for 2018 or 2019.

Field of use and intended applications:

Human space flight and space medicine.

Solutions Currently Under Evaluation:

NASA has successfully used Cochlear and Cerebral Fluid Pressure (CCFP) Analyzer in space for qualitative data and is seeking next generation solutions that can generate quantifiable data. Technologies previously considered are distortion product otoacoustic emission (OAE) and two-depth transcranial Doppler device.