Telephone: 212-305-1319 || Email: alscenter@columbia.edu

RESEARCH: Clinical Trials

Efficacy of Using Cutometer Measurements as a Biomarker for the Progression of ALS

The study seeks to determine if the biomechanical skin changes of ALS patients when evaluated by a Cutometer(R) serve as a sensitive, quantitative and non-invasive biological correlate of disease progression in ALS patient.

The study will evaluate the utility of measuring the biochemical elastic properties of the skin as a biomarker for progression of ALS. These measurements will be obtained through the use of the Cutometer(R), a quantitative device that non invasively measures the ability of the skin to stretch, i.e., viscoelasticity, and the skin's ability to resume its original shape and dimensions, e.e., elasticity. The Cutometer(R) has been used in multiple studies and is considered a cosmetic device with non-significant risk. It is our hypothesis that Cutometer(R) measurements of skin elasticity can serve as a biomechanical biomarker and method of assessment for ALS. The study will determine if these quantitatively measured skin changes found in ALS patients correlate with other clinical signs and symptoms of ALS and the biomarker's ability to predict disease progression during the time period of the study.

Recordings will be taken by study staff trained in the use of the Cutometer(R) on the inside surface of the subject's forearm and lower back. The more severely affected side will be measured in patients who have asymmetrical neurological disease, and on the side of the dominant hand in patients with symmetrical disease and in healthy controls. The spouses of patients enrolled in the study will be asked to serve as controls. The study participants will be followed at each visit, approximately once every 3 months for a maximum of 6 months. Changes in the Cutometer(R) readings over the 6 month period of measurements will be compared between ALS subjects and contorls and the data will be examined to see if Cutometer(R) readings correlate with changes in the ALSFRS-R over the same 6 month period.

If you are interested in learning more or participating in this encouraging pilot study, please contact us at alscenter@columbia.edu or Gabriella Harrington-Moroney gh2002@columbia.edu.