RecruitingNAINTERVENTIONAL

Performance and Safety of a Digital Tool for Unsupervised Self-assessment of NMOSD

This study is looking at a new smartphone app called NMOSDCopilot, designed for people living with Neuromyelitis Optica (NMOSD). This app helps you keep track of your symptoms, like changes in your sight, walking, thinking, and hand movements, from the comfort of your own home. It also connects to a special website for your doctors so they can easily see how you're doing. The main goals are to check if the app's home tests are as good and reliable as the tests you'd normally have at the clinic. We also want to find out if the app is safe, easy to use, and if both patients and their doctors find it helpful.

At a glance

Status

Recruiting

Phase

Sponsor

Ad scientiam

Enrolment target

103

Start

03 Nov 2023

Estimated completion

01 Sep 2026

Neuromyelitis Optica

What is this study about?

This study is exploring a new tool called NMOSDCopilot, created specifically for people who have Neuromyelitis Optica Spectrum Disorder (NMOSD). NMOSD is a rare, lifelong condition that affects the nervous system, potentially causing problems with vision, movement, and other body functions. The NMOSDCopilot is made up of two parts: a smartphone app for you to use at home, and a secure website for your doctors.

Working with patient groups, people with NMOSD, and medical experts, the app was designed to help you regularly check your symptoms that can affect your daily life and sense of wellbeing. It includes simple tests you can do yourself on your phone, covering things like your vision, how you walk, your memory and thinking, and how well you use your hands. There are also some quick questions to answer. The doctor's website lets your healthcare team see your results, making it easier for them to keep an eye on your symptoms remotely.

The main purpose of this study is to see if these home-based tests on your smartphone give accurate and dependable results when compared to the tests you would normally have done in a clinic. We also want to make sure the app is safe to use and that patients find it helpful and easy to navigate. For doctors, we're checking if the website dashboard provides useful information and makes their job of monitoring patients simpler.

Key takeaways

This study is testing a smartphone app for people with NMOSD.
The app helps you check your vision, walking, thinking, and hand skills at home.
It aims to see if home tests are as good as clinic tests for tracking symptoms.
The study also wants to know if the app is safe and easy to use for patients and doctors.
You won't need to take any new medicines as part of this study.
You can stop participating at any point if you wish.

Who may be eligible?

To join this study, you need to be at least 18 years old and have a confirmed diagnosis of NMOSD, specifically the type known as AQP4+. It's important that your NMOSD medication has been stable – meaning no changes for the last six months, and no changes to painkillers, antidepressants, or certain other medications for at least one month. You also shouldn't have had a recent NMOSD flare-up in the three months before starting the study.

You should be able to use a smartphone and own one that runs iOS 13 or newer (for iPhones) or Android 8 or newer. You also need to be able to read the language the app is in and understand its pictures and symbols. Your general health should be stable, meaning you don’t have other serious neurological, rheumatic, or mental health conditions that could interfere with the tests. This study isn't suitable if you are pregnant or breastfeeding, or if you are bedridden or very inactive.

Also, if you're regularly taking drugs or alcohol in a way that might affect your performance on the app's tests, or if you've recently taken part in another clinical study (within the last 30 days) that might clash with this one, you wouldn't be able to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have an AQP4+ diagnosis of NMOSD?
Has your NMOSD treatment been stable for at least 6 months (1 month for pain/mood meds)?
Have you had no NMOSD flare-ups in the last 3 months?
Do you own a smartphone (iPhone 13+ or Android 8+) and can you use it?
Are you able to read the language of the app and understand images?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be using the NMOSDCopilot app on your own smartphone to do various self-assessments at home. These tests cover your vision, walking, thinking skills, and hand movements, and there will also be questionnaires to complete. You won't need to take any new medications as part of this study, as it's purely about testing the app. The number of times you'll need to use the app and how often the assessments are done will be explained in detail. The total duration of your participation will also be clearly outlined, ensuring you know what to expect from start to finish.

Potential risks and benefits

A potential benefit of joining this study is helping to develop a new tool that could make managing NMOSD symptoms easier for patients and their doctors in the future. You'll contribute to scientific understanding and potentially improve care for others. There are minimal risks involved, mainly related to the time commitment for using the app and the possibility of some mild frustration if you find aspects of the app challenging. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (22)

University of Southern California
Verified postcode
Los Angeles, United States· Recruiting
University of California Davis Health
Verified postcode
Sacramento, United States· Recruiting
University of south Florida
Verified postcode
Tampa, United States· Recruiting
NorthShore University HealthSystem
Verified postcode
Evanston, United States· Recruiting
Johns Hopkins Outpatient Center (now called Levi Watkins, Jr., M.D., Outpatient Center)
Verified postcode
Baltimore, United States· Recruiting
Massachussets General Hospital
Verified postcode
Boston, United States· Recruiting
Washington University in St. Louis
Verified postcode
Washington, United States· Recruiting
CC Lou Ruvo Center for Brain Health
Verified postcode
Las Vegas, United States· Recruiting
University of North Carolina at Chapel Hill
Verified postcode
Chapel Hill, United States· Recruiting
Oklahoma Medical Research Foundation
Verified postcode
Oklahoma City, United States· Recruiting
Hôpital Roger Salengro
Verified postcode
Lille, France· Recruiting
CHU Marseille - La Timone
Verified postcode
Marseille, France· Recruiting

Common questions

What is NMOSD?

NMOSD stands for Neuromyelitis Optica Spectrum Disorder. It's a rare condition affecting the brain and spinal cord, often causing problems with vision, movement, and sensation.

What does the NMOSDCopilot app do?

The app helps people with NMOSD check their symptoms at home, such as changes in vision, walking, thinking, and hand movements, using their smartphone.

Why is this study important?

This study is important because it will help us find out if checking symptoms at home with an app is as good and reliable as clinic tests, and if it's helpful for patients and doctors.

Do I need to take new medication for this study?

No, this study is about testing the app, not new medications. Your current NMOSD treatment should be stable and unchanged.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, and it won't affect your medical care.

How to find out more

Dr Levy

mlevy11@mgh.harvard.edu 617-726-7565 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.