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"Speed Bumps": A non-invasive quantitative test for early detection of neuropathy in the feet

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41NS097120-01A1
Agency Tracking Number: R41NS097120
Amount: $210,245.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 101
Solicitation Number: PA15-270
Solicitation Year: 2015
Award Year: 2016
Award Start Date (Proposal Award Date): 2016-09-01
Award End Date (Contract End Date): 2018-08-31
Small Business Information
4103 E LAKE ST
Minneapolis, MN 55406-2259
United States
DUNS: 832721133
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (612) 625-1431
Business Contact
Phone: (612) 728-8080
Research Institution

This STTR Phase I resubmission describes a small deceptively simple portable device called
Speed Bumps that rapidly quantifies the sensation of flutter on the feet toes or fingers in
micrometer m units Flutter frequency is to Hz which is below the approximate lower
vibration range of to Hz This high sensitivity device is designed to differentiate the small
variations of flutter sensation that exist between healthy subjects and detect the reduction of
sensation in the feet of persons with peripheral neuropathy
The Speed Bumps device is designed to diagnose neuropathy very early when the potential for
reversal is highest and to monitor the effectiveness of new therapies appearing from research in
molecular genetics pharmacology nanotechnology and other exciting fields to a degree that is not
now possible
The device is a slender plastic ruler with groups of raised parallel ridges of different heights placed
perpendicular to its length Heights of the groups of ridges range from a high of m to a low of
m Rubbing the ridges to and fro on the skin creates a flutter sensation that mimics the body
sensations produced by highway speed bumps or rumble strips The large skin area contacted by
groups of different height ridges creates a range of stimulus strengths from barely detectable as
needed to measure the threshold stimulus of the toes of healthy persons to a stronger stimulus by the
highest ridges that can be recognized by patients with severe neuropathy Flutter excites the
Meissner corpuscle MC receptors in the superficial dermis that are important receptors for balance
maintenance during many daily activities
We define the flutter threshold as the smallest set of ridges that can be detected by the foot toes
or fingers Normal subjects detect ridge heights andlt m on the fingers in andlt seconds and andlt m on
the feet and toes in seconds This sensitivity exceeds that of current tests and allows rapid early
detection and grading of nerve damage
In Phase I we will build a new prototype of the Speed Bumps device and show feasibility by
measuring the flutter thresholds of small cohorts of healthy adults and of patients with diabetic
neuropathy and chemotherapy induced peripheral neuropathy CIPN CIPN is especially useful for
testing this new device because the time elapsed between the patient having presumed normal
sensation before chemotherapy and developing severe numbness during therapy occurs within
weeks This allows us to test the device during progression of neuropathy in a short cost efficient
study Early diagnosis is beneficial for CIPN patients because it gives treating physicians an early
opportunity to modify treatment at a time when the potential for recovery is greatest and before the
onset of painful neuropathy prevents continuation of treatment
This STTR project responds to a March NCI report that cites a need for rapid sensitive cost
saving methods to test patients with CIPN in their local home environment We are developing a deceivingly simple hand held medical device called Speed Bumps that generates flutter
type stimuli to rapidly objectively quantify sensation on the feet toes and fingers with high sensitivity The
device will be used to detect the earliest signs of peripheral neuropathy in cancer patients receiving
chemotherapy in patients with diabetes and as a screen for neurotoxic effects of new pharmaceuticals

* Information listed above is at the time of submission. *

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