In addition to ALS, the ongoing study is enrolling adults with primary lateral sclerosis (PLS) or related neuron motor diseases, as well as healthy volunteers. The study is seeking participants with and without a family history of ALS.
A total of 500 people are expected to enroll, according to the Northeast Amyotrophic Lateral Sclerosis Consortium, or NEALS, a non-profit that also is encouraging participation in the study.
“The purpose of this study is to determine if ALS disease progression can be tracked via smartphone application use,” NEALS said on its website.
Dubbed the”Answer ALS Companion App Study,” the observational study was launched by Jeffrey Rothstein, MD, PhD, a professor of neurology at the Johns Hopkins University School of Medicine. It is being coordinated by Betsy Mosmiller, senior research program supervisor at Johns Hopkins.
ALS is characterized by the progressive loss of motor neurons, or the nerve cells that are responsible for the control of voluntary muscle movements such as chewing, walking, and talking. Patients may not experience the same symptoms and, for some, the disease progresses more slowly than others.
The recently launched observational trial aims to determine if disease progression in ALS and related motor neuron diseases can be tracked using a smartphone app. If successful, this app could enable patients to participate in clinical studies with less frequent visits to trial sites. That would allow research to continue even during the ongoing COVID-19 pandemic, or when traveling to a trial site is difficult for participants.
To be eligible, an individual must be able to install the smartphone app on his or her mobile device and should have the ability to speak without an assistive device.
Those interested in participating will be asked to answer a few questions showing that they understand the study and its requirements, and to read and electronically sign the consent form.
After giving consent, participants are then asked to complete an online survey with questions about their demographics and basic clinic information. This includes date of birth, gender, ethnicity, level of education, and disease history, if applicable.
As a final step, participants can watch a video showing how to download and install the smartphone application. The video also has detailed instructions for using the app. Participants are free to use the smartphone application for as long as they like.
Over the duration of the study, participants will be asked to complete three tasks each week. Such tasks voice recordings of them reading a sentence out loud, describing a picture for 30 seconds, counting numbers in a single breath, and making an “ah” sound after taking a deep breath.
Those with ALS also will be asked to complete the ALS Functional Rating Scale-Revised, a measure of functional status, at periodic intervals.
The information collected will be de-identified and stored in REDCap, a secure website for medical research.
For more information, including instructions on how to participate, please visit this site. Interested individuals also can contact Mosmiller, the study’s coordinator, at 410-502-0495 or [email protected]
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