Digital Health Tecnologies

---

To enhance the care provided to individuals with Multiple Sclerosis (MS), it is essential to gain a deeper understanding of the disease. Nowadays, the assessment of MS’s impact on daily life has remained static for decades and is primarily based on infrequent clinic visits, occurring once or twice per year. Unfortunately, this method fails to capture the subtle physical and mental changes that may occur between visits, potentially indicating worsening of the MS disease.

However, with the advent of Digital Health Technologies, daily monitoring of MS disease activity and progression is now possible, facilitated by tools like Floodlight – a smartphone-based digital assessment developed by Roche and Genentech. The implementation of Floodlight and similar digital tools could improve patient care by providing a more comprehensive understanding of the disease. Furthermore, such approaches may facilitate the use of innovative measures to detect worsening of disease symptoms. These digital tools, including Floodlight, can support Roche in developing medications through smaller, more efficient, and patient-centric trials.

The unpredictability of living with MS

Multiple Sclerosis (MS) is a chronic and incurable disease wherein the immune system attacks the brain and spinal cord tissue. It affects 2.3 million people worldwide and is the leading cause of non-traumatic disability in young adults. Symptoms may include:

• Fatigue
• Pain
• Visual disturbances
• Mobility issues
• Cognitive decline

The course of MS varies significantly between individuals and is unpredictable, often leading to permanent disability. MS predominantly affects active young adults in their twenties and thirties, with women comprising two-thirds of those diagnosed. Therefore, MS can have a profound impact on individuals who are at the start of their careers and may be making decisions about starting families. Its negative consequences can be life-changing.

Challenges facing the current standards of care in MS

The primary objective of healthcare providers treating individuals with MS is to effectively manage disease activity and minimize the risk of disability progression in a personalized manner. Nevertheless, achieving this goal is challenging due to limitations of the current standards of care. Such limitations include:

• Infrequent clinic visits
• Short appointment times
• Inconsistent examinations across clinicians

This may result in the failure to identify subtle changes in disease progression between visits.

Furthermore, the tools used to evaluate symptoms are often not relevant to a patient’s daily life or are impractical for regular assessment. For instance, the Expanded Disability Status Scale (EDSS) – a widely recognized measure used in trials and clinical practice – is primarily focused on ambulation and may not sufficiently capture other important symptoms such as: 

• Cognitive function
• Upper limb function

Similarly, the nine-hole peg test – another commonly used measure – assesses hand function based on how quickly an individual can place and remove nine pegs from holes, one at a time. Still, these tools do not directly assess tasks that are relevant to a person’s daily life (such as writing or work ability), which makes it complicated to translate the results into meaningful care.

The above limitations could lead to healthcare professionals not recognizing disease activity in a timely manner, which can delay treatment decisions and result in irreversible disability. Real-time digital monitoring of MS outside the clinic is being explored as a possible solution. Current efforts aim to develop tools for enhanced monitoring of MS: advancements in mobile technology and wearable biosensors offer promise for digital health tools to make a difference.

The rise of new technology

The advent of smartphones has revolutionized our ability to stay connected with loved ones and healthcare providers, as well as to continuously monitor our health.

This is made possible by the integration of multiple high-quality sensors into one convenient device, which can measure a range of parameters such as:

• Acceleration
• Gait
• Step count

Smartphones can also detect:

• Geographic location
• Ambient light
• Voice
• Touchscreen pressure
• Atmospheric pressure

By leveraging these sensors, smartphones can be used to monitor heart rate and detect falls, among other applications.

Smartphone-based self-monitoring of Multiple Sclerosis using Floodlight

Roche has developed an app called Floodlight, which includes various remote monitoring tests to assess an individual’s ability to perform basic tasks on their smartphone. Floodlight aims to provide insights into the impact of MS on the brain, hands, and body, and enable daily and continuous monitoring of MS symptoms.

Rediscovering MS with Floodlight

To collect real-time data and potentially track subtle changes in symptoms between doctor visits, the Floodlight app offers a range of active and passive remote monitoring tests that measure:

• Cognition
• Hand motor function
• Mobility

These tests were developed by physicians to help individuals with MS understand their personal journey and provide a clearer picture of their reality. The tasks are designed to complement in-clinic tests and accurately track disease activity and progression. The goal is to enhance the precision of disease monitoring while providing MS affected individuals a better understanding of their condition.

In contrast to the traditional nine-hole peg test, which measures hand motor function, the Floodlight app employs a test called “draw a shape” to assess this ability. With this test, users hold their smartphone in one hand and use the finger of the opposite hand to draw six shapes of varying difficulty on the touchscreen. The app records the entire interaction with the touchscreen and measures performance features such as accuracy and speed, enabling changes to be tracked over time. By providing a daily, faster and more accurate assessment, the draw a shape test may better reflect a person’s ability to write (a task that holds great significance for individuals with MS).

Empowering people living with MS

Empowering individuals living with MS by involving them in understanding and managing their disease is becoming more important. Therapeutic decisions are often made in partnership between the doctor and patient, and research shows that involving people with MS in shared decision-making is crucial for improving their treatment satisfaction and adherence.

The potential for tools like the Floodlight app is that they may allow people with MS to take an active role in tracking their own disease journey using their smartphone. This would facilitate accurate identification of changes in symptoms and promote informed patient-led discussions. The aim is not to replace healthcare professionals, but rather to complement their work, personalize healthcare, and improve the patient-clinician relationship. A recent exploratory study found that people with MS who used the Floodlight app for six months were highly engaged and satisfied, demonstrating the feasibility of using smartphone-based monitoring of MS in everyday life.

Making digital healthcare a reality

Roche is committed to advancing neuroscience not only through the development of new medications, but also through innovative digital tools such as Floodlight. These tools offer the potential for non-intrusive and continuous monitoring of MS disease activity to seamlessly integrate into daily life.

By implementing digital monitoring, early detection of disease progression may become possible. This would result in more effective and timely treatment decisions, ultimately improving long-term health outcomes for people with MS. As technology continues to evolve rapidly, a future patient’s disease could be passively monitored every day of the year using the technology already available to us.