# Home-based actigraphy to predict disability progression and enhance clinical trials in multiple sclerosis

> **NIH NIH R01** · JOHNS HOPKINS UNIVERSITY · 2022 · $681,094

## Abstract

PROJECT SUMMARY/ABSTRACT
While effective immunotherapies exist for relapsing-remitting multiple sclerosis (RRMS), therapies for
progressive MS are limited. In part, this relates to the fact that progressive MS is caused by gradual loss of
central nervous system neurons rather than by immune-mediated injury to the myelin around them. However,
therapeutic development has also been hampered by the lack of quality outcome measures of clinical disability
progression in MS. The inadequacies of the gold standard, the Expanded Disability Status Scale (EDSS),
inflate the sample size and length requirements of progressive MS trials. Further, while clinicians may suspect
that a person with RRMS has transitioned to a progressive course (secondary progressive MS), it often takes
years to confirm using the EDSS. Thus, these patients, perhaps the most informative with much function to
lose, are excluded from progressive MS trials. Phase 2 progressive MS trials often rely on whole brain atrophy,
measured by brain magnetic resonance imaging (MRI), as the primary outcome, which also has limitations.
Considering several neurodegeneration measures concomitantly may improve the efficiency of such trials.
Wearable tri-axial actigraphs are non-invasive, inexpensive devices that measure activity patterns in a home-
based, real-world setting. Using our sophisticated analytic approach that incorporates multiple dimensions of
activity, we are able to distinguish even small numbers of people with MS based on EDSS score. We
propose a longitudinal study of 255 MS patients with confirmed, suspected, or no evident progression,
tracking EDSS and actigraphy-derived data for up to 4 years. We will obtain baseline and subsequent brain
MRIs and other outcomes traditionally used in progressive MS trials to conduct the following aims:
Aim 1. To evaluate if actigraphy-derived measures reliably predict subsequent EDSS-confirmed disability
progression in established progressive MS patients.
Aim 2. To evaluate if actigraphy-derived measures distinguish RRMS patients with and without suspected
progression and predict subsequent risk of EDSS-confirmed disability progression.
Aim 3. To evaluate the relative contribution of actigraphy-derived measures, when combined with traditional
imaging metrics of neurodegeneration, in predicting subsequent clinical disability change.
Corresponding directly to the goal of PA-18-145, this project uses cutting-edge, home-based technology to
predict MS patient trajectories. We anticipate that actigraphy measures will predict subsequent worsening on
EDSS, particularly in those with definite or suspected MS progression, and that adding actigraphy-based
measures to imaging measures of neurodegeneration will improve the prediction of subsequent, EDSS-
confirmed disability progression. If correct, actigraphy will revolutionize the conduct of therapeutic trials for
progressive MS, a critical step for arresting disability accumulation in this common, devastating di...

## Key facts

- **NIH application ID:** 10417231
- **Project number:** 5R01NR018851-03
- **Recipient organization:** JOHNS HOPKINS UNIVERSITY
- **Principal Investigator:** Ellen M. Mowry
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $681,094
- **Award type:** 5
- **Project period:** 2020-09-07 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10417231

## Citation

> US National Institutes of Health, RePORTER application 10417231, Home-based actigraphy to predict disability progression and enhance clinical trials in multiple sclerosis (5R01NR018851-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10417231. Licensed CC0.

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