Quantitative Tactile Examination Using Shape Memory Alloy Actuators for the Early Detection of Diabetic Neuropathy

Diabetic neuropathy (DPN) is asymptomatic in its early phases but can cause serious complications as it progresses. Most DPN tests are cumbersome and produce only qualitative assessments, and simpler approaches that yield quantitative results are needed. Techniques that allow patients to perform examinations themselves would be especially valuable. In this study, we focused on quantifying the decline in tactile sensation associated with DPN and developed a measurement device that used a thin shape memory alloy (SMA) wire as the actuator. An ON/OFF pulse current caused the wire to shrink and expand. This vibration was amplified by a round-headed pin, allowing even DPN patients with reduced tactile sensitivity to detect the stimuli generated when lightly touching the pin with their fingertips. The tactile stimuli were ranked into 30 levels of intensity. A key advantage of the device is that it can be used by patients themselves, returning quantified results within minutes. Although developed for DPN, the method can be applied to the detection of peripheral neuropathy in general

Micro-Vibration Patterns Generated from Shape Memory Alloy Actuators and the Detection of an Asymptomatic Tactile Sensation Decrease in Diabetic Patients

Diabetes mellitus is a group of metabolic diseases that cause high blood sugar due to functional problems with the pancreas or metabolism. Diabetic patients have few subjective symptoms and may experience decreased sensation without being aware of it. The commonly performed tests for sensory disorders are qualitative in nature. The authors pay attention to the decline of the sensitivity of tactile sensations, and develop a non-invasive method to detect the level of tactile sensation using a novel micro-vibration actuator that employs shape-memory alloy wires. Previously, we performed a pilot study that applied the device to 15 diabetic patients and confirmed a significant reduction in the tactile sensation in diabetic patients when compared to healthy subjects. In this study, we focus on the asymptomatic development of decreased sensation associated with diabetes mellitus. The objectives are to examine diabetic patients who are unaware of abnormal or decreased sensation using the quantitative tactile sensation measurement device and to determine whether tactile sensation is decreased in patients compared to healthy controls. The finger method is used to measure the Tactile Sensation Threshold (TST) score of the index and middle fingers using the new device and the following three procedures: TST-1, TST-4, and TST-8. TST scores ranged from 1 to 30 were compared between the two groups. The TST scores were significantly higher for the diabetic patients (P<0.05). The TST scores for the left fingers of diabetic patients and healthy controls were 5.9±6.2 and 2.7±2.9 for TST-1, 15.3±7.0 and 8.7±6.4 for TST-4, and 19.3±7.8 and 12.7±9.1 for TST-8. Our data suggest that the use of the new quantitative tactile sensation measurement device enables the detection of decreased tactile sensation in diabetic patients who are unaware of abnormal or decreased sensation compared to controls