Privacy Notice

APRIL 01st, 2025

Participation in this research is voluntary. You may refuse to participate or stop participating at any time. Your decision will not result in any penalty or loss of services to which you are entitled.

If you have any questions, concerns or complaints, or if you feel that you have been adversely affected by this research, please contact the research team at the telephone number(s) listed in this document.

Invitation & Summary

You are invited to participate in a clinical research project assessing the usability and feasibility of integrating MSCopilot Flower mobile application (InClinical), a digital self-assessment tool, into your routine MS care. This study will evaluate your experience with this application through questionnaires at different timepoints along your user journey.

The MSCopilot Flower solution features a smartphone app named InClinical, downloadable on Google Play Store and Apple Stores, and a web dashboard for your neurologist.

Your participation in this study is entirely voluntary and will last 6 months, until your next follow-up visit with your neurologist. Up to 100 patients with Multiple Sclerosis (MS) in the United States (U.S.) will take part in this study.

During this study, you will be asked to:

perform MSCopilot Flower’s digital tests and questionnaires at home every month and/or more at your own convenience,

Your neurologist will give you a login and password to install the MSCopilot Flower mobile application (InClinical) on your personal smartphone. Between hospital routine visits scheduled with your neurologist, you will be asked to use the MSCopilot Flower mobile application (InClinical) without medical supervision, at home, to complete the following tasks:

Perform digital tests assessing key functions affected by your MS (walking, dexterity, cognition and vision tests) and complete questionnaires on your MS symptoms included in the application, at Day 1 after your inclusion visit (D1), as well as on D30, D60, D90, D120, D150 and D180.
Complete satisfaction and user experience questionnaires. These questionnaires will be sent to you by email at inclusion visit, D1, D90 and D180 and should take approximately 5 to 15 minutes each to complete.

Your participation in the study will not affect the way your doctor follows and treats your MS.

What is the purpose of this study?

The objectives of this study are to assess:

The overall integration of MSCopilot into routine clinical practice,
Patients' ability to use MSCopilot at home without supervision,
The need for patient support when using MSCopilot at home,
User behavior based on usage analytics data from the MSCopilot mobile app and dashboard,
Patient adherence to MSCopilot use in routine clinical practice
The adequacy of the onboarding/training process for HCPs,
The effectiveness of HCPs onboarding/training in ensuring successful patient onboarding,
The impact of socio-demographic factors and EDSS scores on user behavior and adherence to MSCopilot use.

Ad Scientiam, the company sponsoring the study, specializes in developing digital health solutions for patients and HCPs aimed at improving the monitoring of chronic diseases.

While MS is typically monitored by HCPs during regular consultations, you may experience changes in your symptoms between visits. Digital solutions such as the MSCopilot® version 1 application, a CE-marked medical device developed by Ad Scientiam, could help bridge this gap by allowing you to track your MS symptoms at home, providing valuable insights that could support discussions with your healthcare team. The mobile application is designed to be used autonomously at home by people with MS and is also connected to a web dashboard enabling HCPs to access the 2 symptoms collected by the app—either remotely or during follow-up consultations—as a support for discussions with their patients. MSCopilot® version 1 included digital tests to assess low-contrast vision, fine dexterity, walking ability, and cognition. These tests are based on standard MS clinical assessments and have been validated in a clinical study with more than 200 people with MS and healthy volunteers.

As part of the MS-FLOWER study, Ad Scientiam, in collaboration with medical experts and patient associations, has developed a new version of the MSCopilot Flower mobile application (InClinical). This updated version features an improved design, an additional walking endurance test, and validated digital questionnaires assessing mental health and fatigue.

Device studied

The device studied (MSCopilot Flower mobile application (InClinical)) is composed of a mobile application for patients, and an online dashboard for your healthcare provider. The MSCopilot Flower mobile application (InClinical) is composed of five digital tests and two e-questionnaires, to monitor your symptoms.

During your participation in this study, you will therefore have to perform the “Digital Checkup” at home, every month:

Mobile Walking Perimeter Test (MWPT): This test will assess your walking perimeter. The goal is to walk 0,62 miles or 30 minutes maximum, outdoors, on flat ground, without obstacles.
Mobile Dexterity Test (MDT): This test assesses your fine dexterity. The goal is to move a sphere on your smartphone screen as precisely and quickly as possible. This test lasts 2 minutes.
Mobile Cognition test (MCT): This test assesses your attention span and your speed of information processing. The goal is to associate numbers with symbols and then to recognize numbers. This test lasts 2 minutes.
Mobile Vision Test (MVT): This test assesses your low contrast visual acuity. The goal is to read aloud the numbers that appear on the screen. This test lasts 10 minutes.
Mobile Endurance test (MWET) (6min): This test complements the previous walking perimeter test and assesses your ability to walk at a sustained pace for 6 minutes. The goal is to walk as quickly as possible, outdoors, on flat ground, without obstacles.

Once the “Digital Checkup” has been completed, it will be locked for 30 days.

You will receive regular notifications to remind you to complete the digital tests and answer the questionnaires.
Once the first test has started, you will have a 2-day window to complete all the tests and questionnaires of the “Digital Checkup”.
You will also be able to perform the tests more frequently if you wish, thanks to the free test session which will be available every day.
The tests and questionnaires will be offered in a predefined order in the “Digital Checkup”. You will be able to proceed to the next test only if you have completed the previous test, by finalizing it or by indicating that you have finished before the end. The order of completion of the tests and questionnaires will be as follows: MWPT, MDT, MCT, MVT, MWET. You can perform the MWET the next day if you feel too tired. For tests contained in the free test session, you can perform the tests in any order you wish

In addition to these digital tests, you will also have the option to complete questionnaires about your symptoms and their impact on your daily life. Two validated questionnaires will be available in your MSCopilot Flower mobile application (InClinical):

PHQ-8 (Patient Health Questionnaire-8): This questionnaire assesses depressive symptoms over the past two weeks. It consists of 8 questions and takes approximately 3 minutes to complete.
MFIS-5 (Modified Fatigue Impact Scale-5): This questionnaire evaluates the impact of fatigue on your daily life. It includes 5 questions and takes around 2 minutes to complete.

Technical Considerations

To perform the tests, you must own a personal smartphone whose operating system is greater than or equal to version 16 for an iOS (iPhone) and 8 for an Android. You will need to authorize the MSCopilot Flower mobile application (InClinical) to access your smartphone’s GPS, microphone and voice recognition. Access to GPS: the exact coordinates of your movements will not be known and will not be recorded or used. Only your relative positions and distances will be recorded to process mean speed and length on the walk. Access to the microphone and voice recognition: MSCopilot Flower mobile application (InClinical) will only analyze the number of correct and incorrect answers given to the vision test.

What will my participation involve?

Before the start of the study and after signing the consent form, your neurologist will check the eligibility criteria to determine whether you can take part in the MS-FLOWER study.

Inclusion visit (D0) - during your routine hospital visit:

The inclusion visit will take place in 3 steps: 1) Your doctor will introduce you to the study and answer any questions you may have. After signing your consent to participate in the study (at the end of this document), the investigating team will collect:

your socio-demographic data (such as age, gender, and education level)
your clinical data (such as type of MS and Expanded Disability Status Scale (EDSS) score) in the electronic Case Report Form (eCRF).
If you are a woman of childbearing age, you will be required to take a pregnancy test.

2) The doctor will give you a login and a password to log in to the application. These identification codes will remain the same throughout your participation. Your doctor will then explain how the application works and provide you with a user manual.
3) Once you’re back home after your inclusion visit, you can connect to the application and perform your first session in autonomy as soon as possible.

End of study visit at 6 months (M6) (+/- 2 weeks) - during your routine hospital visit:

The end-of-study visit will take place approximately 6 months after your inclusion visit. During this end-of-study visit, the following procedures will be carried out:

The investigating doctor will record any special events that may have occurred since your last visit.
You will be asked to complete a final satisfaction and user experience questionnaire.
You will be asked to log out and uninstall the application with your doctor’s guidance.

Between visits, you will be required to perform the digital tests described in the 'Device studied' section above and complete satisfaction and user experience questionnaires.

Early termination visit:

You or your doctor may decide to stop your participation in the MS-FLOWER study at any time. All we ask is that you notify your doctor.

During this visit, the investigating doctor will record the following information:

The reason for premature termination,
Any special events that have occurred since the last visit.

Your doctor will also assist you in logging out of and uninstalling the MSCopilot Flower mobile application (InClinical).

This early termination will have no impact on your usual treatment, nor on your relationship with your doctor.

Is there any discomfort or risks?

Participation in this study does not pose any additional risks beyond those associated with your usual care or daily life. The risks associated with this research are therefore considered minimal. However, performing MSCopilot Flower mobile application (InClinical) tests may involve some discomfort:

You may feel temporarily tired.
You may feel anxiety triggered by misinterpretation of tests results.
You may hurt yourself if you perform the tests in an unsafe environment (for instance, performing a walking test when there is ice on the ground could lead to slipping and falling).
There may also be unforeseen risks associated with your study participation in this study.

Even though no specific risks have been identified, if you are a pregnant woman or plan to become pregnant during the study, you cannot participate in this research. This decision is made in accordance with clinical regulations to ensure safety. If you become pregnant during the study, you must immediately inform the investigating doctor.

Will I be paid for my participation?

You will receive up to $150 by gift card ($25 per questionnaire completed and a $50 bonus if all questionnaires are completed) for completing the four satisfaction and user experience questionnaires sent by email. However, to ensure an unbiased user experience with the tool, you will not be compensated for the time spent using the MSCopilot Flower mobile application (InClinical).

Will compensation be paid in the event of an injury?

If you are physically injured as a result of participating in this research, emergency care will be available. You will, however, be billed for the charges for the emergency care. There is no plan to provide any compensation for research-related injury, but you have not released your institution from liability for negligence. Please contact the Site Investigator at the number(s) listed at the beginning of this document if you believe you are injured or require further information.

What if I have questions?

If at any time during the study you have questions, complaints or concerns, you are encouraged to contact the Investigator at the number(s) listed at the beginning of this document. This research is being overseen by WCG IRB. An IRB is a group of people who perform independent reviews of research studies. You may contact them at 855-818-2289 or clientcare@wcgclinical.com if you have questions, concerns, or complaints or questions about your rights as a research subject or if you are unable to reach the research team

How will my personal information be protected and kept confidential?

This study is conducted and sponsored by Ad Scientiam (38 rue Dunois 75647 Paris CEDEX 13, France).

If you agree to participate in the study, Study data, including your coded medical information, will be used, which means it will be collected, entered into computer databases, stored, accessed, verified, analyzed, transferred, printed and reported as necessary for scientific purposes by:

Ad Scientiam (38 rue Dunois 75647 Paris CEDEX 13, France), Sponsor of the clinical study Investigators, investigating sites and staff, for the conduct of the study, located in the United States,
The Institutional Review Board/ Ethics Committee that oversees the research study at your site,
Government regulatory agencies including US Food and Drug Administration, European Medical Agency, and other Regulatory Authorities worldwide,

Deidentified study data may be shared with third party pharmaceutical companies for research purposes. Your identity and personal data will never be revealed.

Furthermore, Ad Scientiam, Sponsor of the Study, may also use de-identified Study data about you in future health research or for the development of new biomarkers or medical devices. To obtain more information about the use of your Study data, Ad Scientiam has set up a dynamic website (“transparency portal”) which you can consult regularly and prior to the implementation of each new health research or data processing, at the following address: https://privacy.adscientiam.com/en/transparence. You may object to the re-use of your information by contacting the Sponsor's Data processing officer at the following e-mail address: privacy@adscientiam.com.

If you have any questions regarding the use of your personal information, you may contact the Investigator at the number(s) listed at the beginning of this document. Should you have any comments, communications or complaints addressed to Ad Scientiam’s Data processing officer (privacy@adscientiam.com) they should be first relayed to the Investigator, if at all possible, in order to protect your privacy

Which information will be collected?

The following personal information will be collected:

Administrative identification information: your personal email address, which will only be accessible by the service provider in charge of collecting the study data in order to send you the questionnaires by email. It will never be disclosed to Ad Scientiam as the study Sponsor
Identification data: unique identifier for the MSCopilot Flower mobile application (InClinical),
Your socio-demographic data: month and year of birth, sex, level of education,socio-professional category, working life,
Clinical data: type of MS, EDSS score, adverse events, medical contraindications likely to influence results or make participation in the study impossible.
Raw data from MSCopilot Flower digital tests and questionnaires: timestamp, sensors, accelerometer, gyroscope, relative position, sound of voice, answers you give to questions (dominant/non-dominant hand, are you able to see with both eyes, which hand do you use first to take the test, etc.) and questionnaires (answers you give to the various questionnaires in the application).
Metadata for MSCopilot Flower digital tests and questionnaires: start date, end date of test or questionnaire, reason for stopping, etc.
Data related to the course of the research: date of visit, participation in other ongoing studies, reimbursement of expenses incurred by the person concerned in connection with the research, annual amount of compensation received.

In addition, as part of the vision test, you will be asked to speak numbers that appear on the screen. In order to determine whether the number spoken corresponds to what is displayed on the screen, your voice will be recorded and then transcribed into text format. To do this, we use the text transcription modules already built into your smartphone: the voice recording will then be transferred either to Apple if you're using an Apple device, or to Google or your phone manufacturer if you're using an Android device (depending on your smartphone settings). Only the voice recording will be sent to them, no other data about you will be transferred. Once your recordings have been transcribed into text, Sponsor receives them in text format to verify their accuracy. As a result, Sponsor does not receive your voice recordings, only their text transcriptions. As the servers of Apple, Google or the manufacturer of your smartphone are located all over the world, your voice recordings may be transferred outside the USA.

If you would like more information about the personal data collected, you may contact the Investigator at the number(s) listed at the beginning of this document.

How long will my personal data be kept?

This informed consent form, and the personal information collected as a part of this study will be kept until 2 years after the publication of the final study report, unless legal retention requirements force the Sponsor to keep the data for a longer retention period.

Your information will be archived by the Sponsor, the Investigators, investigating sites and staff for a maximum of fifteen (15) years after the study has ended, in accordance with applicable regulations.

After this delay, your information will be securely deleted or anonymized. For example, it can be used in a non-identifiable way for statistical analysis and business purposes.

Will study results be confidential?

The results of the research may be presented at scientific meetings or in publications; however, your identity will not be disclosed.

You are providing personal information as a result of your participation in the study, which may lead to a slight risk of loss of confidentiality. Every effort will be made to protect this information from disclosure. However, the U.S. Food and Drug Administration (FDA) and other regulatory offices may inspect study records. At the initial session you will be assigned a unique participant number that will be used throughout the study. Your personal identity will not be revealed in publications that may result from this study, nor will your name be used in other research communications such as lectures at scientific meetings. Experimental data as well as personal information will be kept securely by the Investigators and will not be released in any way that could be identified with you personally. Only summary statistics such as your age and gender will be included in published experimental results. This consent form, as well as any form which contains your personal contact information, will be stored in a location accessible only to the Site Investigator or approved designee.

A description of this clinical trial will be available at http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Website will include a summary of the results. You can search this Web site at any time

Is there any benefit to participation?

While you may not personally benefit from participating in this study, your participation will help improve MSCopilot Flower mobile application (InClinical) and contribute to the deployment of a solution that could benefit the entire MS community in the future. Your feedback will be invaluable in shaping this tool, which could enhance MS symptom monitoring and support better communication between people with MS and their healthcare team.

What if I change my mind?

Participation in this study is entirely voluntary. You may choose not to take part or may leave the study at any time. Refusing to take part or leaving the study will not result in any penalty or loss of benefits to which you are otherwise entitled. If you change your mind at any time, you are free to end the session and to withdraw from the study. Your decision of whether to participate in this study will not affect the quality of the medical care you receive at this facility. You may take as much time as you need to make up your mind if you will participate.

Your decision regarding the processing of your personal data will not result in any harm. You may withdraw your consent to the processing of your personal data at any time without justification and without consequence. If you choose not to consent or to withdraw your consent to the collection, access, use, storage, disclosure, and transfer of your data, you will not be able to participate in the study, as your data is needed to conduct the study. If you revoke your consent, your participation in the study will end with the completion of the Early Termination/End of Study visit(s) and the study personnel will not collect any new medical information from you. However, the withdrawal of your consent will not affect the research activities carried out and the use of your information obtained before your consent was withdrawn.