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THERAPEUTIC EXPERTISE

Solutions for
Neuromuscular
Disorder Research

Existing clinical outcome measures are often inadequate for assessing drug efficacy in neuromuscular disorder (NMD) trials, making the development of novel treatments a challenge in an area where there is a large unmet need for new therapy options. Wearable digital health technologies (DHTs) provide an unprecedented opportunity to directly and objectively assess real-world function to accelerate drug development in NMDs.

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Indications Where DHTs Have Been Included in Clinical Development

  • Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig’s disease)
  • Duchenne’s Muscular Dystrophy (DMD)
  • Myotonic Dystrophy
  • Spinal Bulbar Muscular Atrophy (SBMA, or Kennedy’s disease)
  • Spinal Muscular Atrophy

Selected Digital Endpoints for Neuromuscular Disorder Research

Physical Activity

  • Moderate to Vigorous Physical Activity (MVPA)
  • Non-Sedentary Time

Gait & Mobility

  • Gait Speed / Cadence
  • Real-World 6-Minute Walk Distance

Sleep

  • Wake After Sleep Onset (WASO)
  • Total Sleep Time
  • Sleep Efficiency

Upper Limb Function

  • Wrist Activity Counts
  • 6-Minute Peak Activity (Wrist)
  • Specific Upper Limb Movement Metrics

Vital Signs

  • Heart Rate / Heart Rate Variability
  • Arrythmia Burden
  • Respiratory Rate
  • Oxygen Saturation
  • Blood Pressure
  • Skin Temperature
Physical Activity
  • Moderate to Vigorous Physical Activity (MVPA)
  • Non-Sedentary Time
Gait & Mobility
  • Gait Speed / Cadence
  • Real-World 6-Minute Walk Distance
Sleep
  • Wake After Sleep Onset (WASO)
  • Total Sleep Time
  • Sleep Efficiency
Upper Limb Function
  • Wrist Activity Counts
  • 6-Minute Peak Activity (Wrist)
  • Specific Upper Limb Movement Metrics
Vital Signs
  • Heart Rate / Heart Rate Variability
  • Arrythmia Burden
  • Respiratory Rate
  • Oxygen Saturation
  • Blood Pressure
  • Skin Temperature
Patient performing 6-minute walk

Clinical Measurement Challenges in Neuromuscular Disease

Conventional clinical assessments in ALS, DMD, and other neuromuscular diseases are episodic, capturing only infrequent snapshots of a continuously progressing disease. This limits sensitivity to early and subtle changes, introduces rater variability, and leaves systematic gaps in how progression and treatment response are measured.

  • In ALS, the ALSFRS-R requires a ~3-4-point change to constitute meaningful difference — a high bar in smaller cohorts with limited statistical power.
  • In DMD, the North Star Ambulatory Assessment (NSAA) faces the same constraint: supervised, rater-dependent, and limited to periodic clinic visits.
  • Across indications, the 6-Minute Walk Test (6MWT) is validated exclusively in ambulatory patients, creating an inherent measurement gap as disease progresses, leaving non-ambulatory patients without a comparable endpoint.

Neuromuscular Disorders Digital Endpoint Guide

To learn more about opportunities with wearable digital health technologies in Neuromuscular Disorder clinical trials, download our full guide.

Download the Guide

Solution for Neuromuscular Disease
Continuous Coverage Across the Full Disease Trajectory

Ametris delivers a digital measurement solution purpose-built for NMD — powered by the FDA-cleared, multi-sensor ActiGraph LEAP® worn at the ankle, wrist, or upper arm. Unlike episodic clinic-based assessments, our DHT platform captures objective, continuous functional measures across the full spectrum of disease progression.

Our platform integrates Stride Velocity 95th Centile (SV95C)—the first EMA-qualified digital primary endpoint in NMD to measure peak gait performance—with 6-Minute Stride Velocity 95th Centile (6M95C) to track effort-independent skeletal muscle function across ambulatory and non-ambulatory patients. Continuous wrist-worn upper-limb monitoring is validated against Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) subscores.

  • SV95C: The first and only EMA-qualified digital primary endpoint in NMD, measuring peak gait performance in ambulatory patients with sensitivity up to 6 months earlier than traditional assessments
  • 6M95C: A novel, effort-independent measure of skeletal muscle function applicable across ambulatory and non-ambulatory patients, extending meaningful coverage where gait endpoints end.
  • Upper Limb Monitoring: Continuous wrist-worn activity capture, validated against ALSFRS-R upper limb subscores and critical when ambulatory measures are no longer applicable.

Together, these measures — alongside gait, activity, and sleep monitoring — deliver continuous, real-world functional assessment with earlier detection of clinically meaningful change across every stage of disease

Learn more about the 6M95C measure

Key Platform Features

  • Full-spectrum Patient Coverage
    Digital measures applicable for both ambulatory and non-ambulatory patients
  • FDA-cleared, Medical-grade Wearables
    ActiGraph LEAP® validated across multiple NMD indications
  • Participant Adherence Monitoring
    real-time visibility into wear compliance throughout the trial
  • Regulatory-qualified Endpoints
    EMA-qualified SV95C enables more sensitive primary or secondary endpoints in pivotal trials

Digital Measures for Neuromuscular Disease

gfx-actigraph-leapAmetris delivers a comprehensive digital measurement solution purpose-built for NMD clinical research.  capturing objective, continuous data across the full spectrum of disease progression. Powered by the FDA-cleared, multi-sensor ActiGraph LEAP®, worn at the ankle, wrist, or upper arm to match each measure's clinical intent, our fit-for-purpose solution captures objective, continuous digital functional measures across the full spectrum of NMD disease progression, in the natural environment. From ambulatory to non-ambulatory stages, every patient is covered.

Solutions What It Measures Regulatory Status Patient Applicability Key Strength
SV95C
(Stride Velocity 95th Centile)		 Peak stride velocity during daily walking — 95th percentile from ankle-worn ActiGraph LEAP® over ~180 hours EMA-qualified as primary endpoint in DMD; applicable to BMD, SMA, SBMA, ALS Ambulatory patients Only EMA-qualified digital primary endpoint in NMD; detects meaningful change 6-12 months pre-ambulation loss
6M95C
(Six-Minute Activity 95th Centile)		 Peak activity over 6-minute windows from wrist-worn accelerometer — effort-independent measure of skeletal muscle function Novel; published validation in DMD (Joy et al., 2025) Ambulatory AND non-ambulatory patients Effort-independent; works across all disease stages; strongly correlates with muscle strength and disease progression
Gait & Mobility Package Real-world gait speed, cadence, step count, walking distance — from ActiGraph LEAP® ankle sensor Validated against traditional COAs in ALS and SBMA Ambulatory patients Captures real-world walking function missed by supervised 6MWT in clinic
Upper Limb Package Wrist activity counts, 6-minute peak activity — from wrist-worn ActiGraph LEAP® Validated in ALS; DMD validation in progress All patients Tracks upper limb function when ambulatory measures are no longer applicable; critical for ALS and progressive NMDs
Physical Activity & Sleep MVPA, non-sedentary time, WASO, total sleep time, sleep efficiency — from ActiGraph LEAP® Validated across multiple NMD indications All patients Comprehensive functional picture; sleep disruption is a key patient-reported concern in ALS and DMD
Participant and Nurse two people shaking hands over a desk

Digital Health Monthly

Learn more about the latest research using DHTs to capture continuous and objective data related to the motor function of ambulatory patients with DMD, providing more detailed data on disease progression and treatment efficacy.

Patient-Focused Digital Measures Reports

Regulatory agencies acknowledge the need to improve clinical endpoints for NMD drug development and the potential of DHTs to address this need. 

Access our NMD digital measure reports inspired by the FDA’s Patient-Focused Drug Development (PFDD) initiative, leveraging information from Voice of the Patient summaries to highlight how digital health technologies can help measure symptoms that are meaningful to patients.

Experience in Neurology Trials

83
trials
1,482
sites
44
countries
5940
participants

Let’s Connect

Have questions or need assistance? Our team is here to help. Learn more about how Ametris’s innovative solutions can support your research and patient care goals.

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