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Research

FDA Taps Â鶹ÊÓƵto Develop New Digital Measures for Huntington's Disease

Oct. 7, 2024

New funding will enable researchers to determine whether subtle early signs of Huntington's disease can be detected by wearable sensors. Developing digital tools to identify objective measures of this complex disease will help accelerate the development of new therapies. The study will be led by the University of Rochester’s Center for Health + Technology, which has been studying digital health technologies in Parkinson's disease for a decade.

“Similar to Parkinson's, our traditional measures of Huntington's disease are subjective, episodic, and have not reliably been sensitive to progression, especially in early disease,” said Â鶹ÊÓƵ (URMC) neurologist Jamie Adams, MD, principal investigator of the new study. "Huntington's is a genetic disease with a long pre-symptomatic stage. This study employs a new staging system and focuses on the early stages, which are the likely target populations of disease-modifying clinical trials."

The new research is being funded by the Food and Drug Administration (FDA), under the program. The FDA has tasked Â鶹ÊÓƵand collaborators with demonstrating the reliability, validity, and meaningfulness of two key digital measures: daily living mobility (gait) and chorea, the involuntary muscle movements that are a hallmark symptom of the disease. Data will be captured remotely and continuously using wrist and trunk-worn digital sensors in individuals with early-stage Huntington's disease and controls. The study also includes qualitative work using an innovative symptom mapping approach to ensure meaningfulness of the measures to people with Huntington’s disease.

"We believe that gait and chorea are meaningful measures in Huntington’s disease, and this study will help confirm that. They're both significant features of the disease that worsen over time and contribute to functional decline, and are present, we think, early in the disease in a subtle way," said Adams.

The hope is that these digital measures will prove to be crucial endpoints for clinical trial outcomes in Huntington's. As genetic and disease-modifying interventions for neurological disorders like Huntington's emerge, there is an urgent need for early and accurate assessment of motor impairments. The goal of this research is to ultimately inform larger-scale validation efforts and clinical endpoint studies in Huntington's. This work also has the potential to impact other, more common neurological diseases with involuntary movements, such as Parkinson's.

Key personnel of the team also include Lori Quinn, PhD, with Columbia University, Jeffrey Hausdorff, PhD, with Tel Aviv University, and Jennifer Mammen, PhD, with the University of Massachusetts. Researchers expect to start enrolling participants in the study later this year.