ki:elements

Motor Function · SB-M + SB-C

Detect and track bulbar involvement with ALS subtypes

The SB-M objectively detects declining speech intelligibility, while the SB-C tracks parallel shifts in cognitive performance. Together, a single brief speech protocol captures both motor and cognitive status to support trial inclusion, enrichment, and progression prediction.

At a glance

0.86 AUC

Dysarthria severity classification

<10

Mins. per app-based assessment

Languages available

PROBLEM

The ALS
Measurement Gap

8–12 weeks

intervals for data collection in ALS trials. Changes can occur earlier than this.

intervals for data collection in ALS trials.
Changes can occur earlier than this.

50%

of people with ALS exhibit neuropsychological changes

30%

of people with ALS present with bulbar onset — the hardest subgroup to track

36%

Rate of attrition over a 12-month ALS study

SOLUTION

A ~10-minute app assessment to provide increased granularity and sensitivity

A 5-minute app assessment to provide increased granularity and sensitivity

The SB-M captures bulbar subtypes through a short, standardized speech task. AI-driven analysis extracts features to return an objective Intelligibility Score, which is important and meaningful to patients with ALS, as well as articulation and respiration subscores. The SB-C can be easily added to track and monitor cognition.

Assessment Protocol

Participant opens Mili

Any smartphone,

any location

Standard smartphone app or webpage. No special microphone, no wearable, no site visit required.

Standardized speech tasks administered

~10 minutes

Picture description, text reading, sustained phonation, and diadochokinesis are performed.

AI pipeline extracts intelligibility and acoustic features

Automated

The SIGMA pipeline automatically generates the SB-M Intelligibility Score, alongside articulation and respiration subscores, and single features, such as speech rate. No manual transcription required.

Score delivered via API or Mili dashboard

Same day

Structured output integrates into your EDC, CTMS, or study portal. Full audit trail. Longitudinal trajectory visualization available for site monitoring teams.

VALIDATION

Proven clinical validation across indications and languages

DiMe V3 Aligned

SB-M validation follows the Digital Medicine Society’s V3 Framework, covering verification, analytical validation and clinical validation.A full validation package is available for regulatory submissions.

Multiple Languages

Validated in German, English, Czech, Italian, Swedish, French, Spanish, and Colombian Spanish ALS cohorts. Supports multilingual, multinational clinical trial deployment.

Clinical Scale Anchors

SB-M and SB-C results are anchored to established clinical measures used in ALS trials: ALSFRS-R and ECAS.

Clinical Scale Anchors

SB-M and SB-C results are anchored to established clinical measures used in ALS trials: ALSFRS-R and ECAS.

EVIDENCE

Key Publications in ALS

ARTICLE

Automatically measured speech intelligibility models bulbar-specific disease severity and progression in Amoyotrophic Lateral Sclerosis

Troger et al. — Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 2025

ARTICLE

Automatically measured speech intelligibility models bulbar-specific disease severity and progression in Amoyotrophic Lateral Sclerosis

Troger et al. — Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 2025

ARTICLE

Automatically measured speech intelligibility models bulbar-specific disease severity and progression in Amoyotrophic Lateral Sclerosis

Troger et al. — Amyotrophic Lateral Sclerosis and Frontotemporal Degeneration, 2025

BOOK CHAPTER

Preliminary Digital Assessment of Bulbar Function in ALS: an Exploratory Analysis of Parsimonious and Speech Features

Giugliano et al. — SOCO, 2026

BOOK CHAPTER

Preliminary Digital Assessment of Bulbar Function in ALS: an Exploratory Analysis of Parsimonious and Speech Features

Giugliano et al. — SOCO, 2026

BOOK CHAPTER

Preliminary Digital Assessment of Bulbar Function in ALS: an Exploratory Analysis of Parsimonious and Speech Features

Giugliano et al. — SOCO, 2026

POSTER

Robust Digital Bulbar Monitoring in ALS Using a Minimal, Interpretable Speech Feature Panel

Thies et al. — ENCALS, 2026

POSTER

Robust Digital Bulbar Monitoring in ALS Using a Minimal, Interpretable Speech Feature Panel

Thies et al. — ENCALS, 2026

POSTER

Robust Digital Bulbar Monitoring in ALS Using a Minimal, Interpretable Speech Feature Panel

Thies et al. — ENCALS, 2026

ARTICLE

An automatic measure for speech intelligibility in dysarthrias- Validation across multiple languages and neurological disorders

Troger et al. — Frontiers in Digital Health, 2024

ARTICLE

An automatic measure for speech intelligibility in dysarthrias- Validation across multiple languages and neurological disorders

Troger et al. — Frontiers in Digital Health, 2024

ARTICLE

An automatic measure for speech intelligibility in dysarthrias- Validation across multiple languages and neurological disorders

Troger et al. — Frontiers in Digital Health, 2024

View All Publications

Ready to add
speech biomarkers

to your ALS trial?

Ready to add speech biomarkers to your ALS trial?

The ki:elements team works with ALS clinical operations and endpoint strategy teams to integrate SB-M into study designs. Most conversations start with a 30-minute scoping call.

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