Objective:

To develop, refine, and evaluate a speech assessment app (Mili) for monitoring multiple sclerosis (MS) through structured co-creation and iterative cycles.

Approach:

• Study Design: A single-center, prospective, non-interventional Living Lab study at the MS Center Dresden, involving co-creation with people with MS (pwMS) and clinicians.
• Demonstrator Cycles: Three demonstrator cycles involving co-design feedback, implementation, usability evaluation, and documentation of changes.
• Speech Assessment: The app includes multiple speech tasks and a dual-task module, focusing on usability, acceptability, and engagement.
• Ethical Oversight: A dedicated Ethical, Legal and Social Issues (ELSI) board provides continuous oversight throughout the study.

Key Findings:

• Digital health tools can provide frequent, low-burden measurements for MS monitoring.
• Speech metrics may align with symptom severity and clinically relevant domains in MS.
• Iterative usability refinement and stakeholder engagement are crucial for developing clinically useful digital biomarkers.

Interpretation:

The study aims to bridge the gap between technical feasibility and clinical usefulness of speech-based digital biomarkers in MS.

Limitations:

• The study is limited to a single center and may not be generalizable.
• Focus on development and usability rather than clinical efficacy or final validation of digital biomarkers.

Conclusion:

MSPEECH represents a structured approach to developing speech-driven digital biomarkers for MS, emphasizing co-creation and ethical governance.