New ALS Biomarker Study Open for Enrollment

by Harvey Arbesman, M.D.

There is a great need for a reliable and easy to use method to assess the progression of Amyotrophic Lateral Sclerosis (ALS) in order to accurately monitor both the disease and efficacy of treatment.

It has been noted in the medical literature that even when ALS patients are immobile at the terminal stage, they do not develop bedsores as would be expected. The skin of ALS patients has also been described as being supple and as having reduced elasticity. It is possible that these skin changes correlate with the extent and severity of neurological disease since many of the underlying biochemical and structural changes found in the skin of ALS patients are correlated with disease duration.

The purpose of this research study is to determine whether measuring changes in the elastic properties of the skin through the use of a Cutometer® can serve as an indirect measure of the progression of ALS. The Cutometer® is a minimal risk device that measures the elasticity of the skin through a gentle, painless, suction on the skin. In this study, the changes in the elastic properties of the skin as measured by the Cutometer® will be compared to changes in the neurological function of the patients. Recordings will be taken by study staff trained in the use of the Cutometer® on the inside surface of the subject's forearm and lower back. The spouses of patients enrolled in the study will be asked to serve as controls and they will also be measured using the Cutometer®. Participants (enrolled patients and spouses) will be followed at each regular visit at the Center (approximately once every 3 months) for a maximum of 6 months. Changes in the Cutometer® readings over the 6 month period of measurement will be compared between ALS subjects and controls and we will examine the data to see if Cutometer® readings correlate with changes in neurological function over the same 6 month period.