MOUNTAIN VIEW, Calif. - There is no cure for ALS, the progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord, but a Silicon Valley nonprofit is hoping to change that.
Starting Tuesday, EverythingALS, a Silicon Valley nonprofit and advocacy group, is starting its second research study involving ALS patients, using shoes with high-tech censors to track and study their movements. The study is open to 100 participants in the early stages of ALS, and is still accepting new participants.
Indu Navar, the founder and CEO of EverythingALS, started the nonprofit two years ago from her Los Altos home. It's part of the Peter Cohen Foundation, named for Navar's husband who died from the disease in August 2019.
Despite seeking medical expertise early on in his symptoms, when his ankle wasn't supporting his foot, Cohen and Navar still waited nearly three years before doctors diagnosed Cohen with ALS.
"We heard 'it's too early to say what it is. Come back in eight months,'" Navar recalled when they first approached doctors for treatment options.
She said it's typical for doctors to first rule out all other diseases before diagnosing a patient with ALS, and by then, "it's like finding stage four in cancer," Navar said. "And it's too late."
In December 2020, EverythingALS launched a speech study, using an artificial intelligence platform designed by San Francisco-based Modality.Ai., to analyze voices and facial movements. So far, close to 1,000 participants, both ALS patients and from the public, have logged into the online platform to record their voices via their webcams. It takes less than 10 minutes to do, and participants record their voices once a week for an entire year. The study is ongoing, and still accepting participants.
"The AI really figures out what are the key features within speech that's implicated in ALS diagnosis," Navar said.
After the shoe censor study gets going, two more studies are in the works, measuring breath and fine motor skills in ALS patients.
Earlier this month, EverythingALS signed an agreement with the Critical Path Institute, an accelerator research program funded by the United States Food and Drug Administration.
"What we are doing is peeling the onion one by one," Navar said. "Our goal is by the end of the year, we want to have an algorithm and a biomarker in front of the FDA," Navar said.
These studies, aimed at generating digital biomarkers that track early ALS decline, have the potential to help doctors diagnose patients significantly earlier in their symptoms and help track the effectiveness of drugs in clinical trials.
It brings hope to Lisa Cross, 66 of San Mateo. She was diagnosed with ALS in 2017. Cross was an early participant in the EverythingALS speech study.
"It's studies like this one that will find the key, at least to earlier diagnosis," Cross said.
A longtime dance and theater instructor, Cross continued to dance and stay active, despite her diagnosis. However,in December 2021, when the muscles in her limbs began deteriorating, she stopped dancing. Her younger sister, Carol, died from the disease in February, and her three adult children each have a 50/50 chance of developing ALS.
"I really think it will save their life," Navar said of the work toward earlier diagnoses of ALS. "I honestly believe if we had this mechanism [of using digital biomarkers] Peter would be alive today."