About the project

Project Name: FOCI (Focus on Cognitive Impairments)

Organization: Northeastern University, Department of Electrical and Computer Engineering

Investigators: Sumientra Rampersad, Ph.D.; Michael (Misha) Pavel, Ph.D.; Maciej Kos, MA, MSc

What is the goal of this study?

The goal of this research is to develop new mobile technology for monitoring changes in memory and attention. Your data may help develop new ways for detecting and tracking changes in cognitive impairments as well as advance our understanding of conditions such as mild cognitive impairment and subject cognitive decline. Your participation will likely help this research and technology reach its full potential.

What is the key information about this project?

The study consists of:

  • Three in-person meetings in our lab, of 2 to 3 hours each.
  • The first in-person session will take place after you are enrolled in the study. The second meeting will take place after 6 months. The third meeting will take place after 12 months.

The procedures that you will be asked to complete include:

  • During the 3 lab visits, you will be asked to answer brief demographic questions, complete a series of thinking and movement tasks, and have electroencephalography (EEG) of your head.
  • Throughout the 12 months of the study, you will receive, on average, one message every two days, and no more than three messages per day, on your phone asking you to respond to a brief question.
  • [optional] Allowing researchers to export your Android activity data, i.e., your movement data, what apps you use and when from your Google account, and to install a data collection app on your smartphone.

What phone do I need to participate in the study?

You need to have and regularly use an Android smartphone with a data plan. The version of your Android operating system should be 7 or higher. To check what version of Android your phone uses, go to this page.

Unfortunately, iPhones cannot be used in this study.

Why am I being asked to take part in this research study?

We are asking individuals with and without mild or subjective cognitive impairment to participate. You have shown an interest in helping us develop new mobile technology for detecting and monitoring cognitive impairments. You are between 45 and 65 years of age, able to speak and read English, you own and use an Android smartphone with a data plan.

You are not pregnant or planning on becoming pregnant, are not diagnosed with dementia or any condition preventing you from leaving home, you are not diagnosed with unstable major depression (not including postpartum related), unstable anxiety disorder, epilepsy, seizures, multiple sclerosis, traumatic brain injury, post-traumatic stress disorder, psychosis, bipolar disorder, Alzheimer’s disease, Parkinson’s disease, vascular dementia, schizophrenia. If you are diagnosed with sleep apnea, you are planning to start CPAP treatment within the next six months.

What will I be asked to do?

You will be asked to come to our lab. Before entering the lab, we will ask you some basic health questions, we may take your temperature using a touchless thermometer, and may ask you to wear a face mask covering your mouth and nose. If needed, the research staff will wear a mask.

During your first lab session, a member of our research team will take you through the consent process and we will ask your age, gender, sex at birth, and additional demographic information. We will also ask you to tell us your height and weight. We are asking for this information because we would like to calculate two things. First, we would like to calculate how many calories you burn per day. Second, we would like to calculate how tiring physical activities may be for you. Knowing your height and weight would help us in these calculations. Then we will ask you to do a few memory and thinking tasks, and some simple movement exercises. The researcher will also ask you for an email address or address where we can send you a gift card or a check.

We will ask you to undergo an electroencephalography (EEG) session, which takes approximately 25 minutes. We will use EEG electrodes placed on your scalp to measure electric potentials generated by your brain. EEG is routinely used in clinical care and in experiments performed for research projects. Small currents that continuously occur in your brain will be picked up by electrodes connected to your scalp by conductive gel. You will be asked to sit quietly and rest during this procedure.

EEG is of minimal risk and should cause no harm. There is a small chance that you may experience some scalp irritation from the electrodes.

[Optional] We will also ask you to allow us to export your Android activity data, i.e., your movement data, what apps you use on your phone and when. If you don’t agree to your share these historical data, you will still be able to participate in the study and be eligible to receive full compensation. We will not export any emails, messages, photos, videos, or browsing history. You will log into your Google account on our secure lab computer. We will export your Android activity data using Google’s service called Google Takeout. We will encrypt and save the data on the computer and log out of your Google account. To ensure nobody can access your account, we will clear the browser’s cache and cookies.

Next, we will install our research data collection app on your phone. The app collects the following data:

  • the time when the device is on or off

  • the time when the device locked or unlocked

  • the time when the screen is on or off

  • the device’s location and mode of transportation (standing, walking, biking, car/train/bus)

  • the time and name of the mobile application used

  • the time you answered a call

    • we do not record who participated in the conversation
    • we do not record the calls
  • how quickly you type, how often you tap the delete key and the space key, how often you use autocorrect

    • we do not record what text you type
  • what apps send you notifications; the time you receive them and when you dismiss them (if you do)

    • we do not record what the notifications are about or what they contain; for example, if you received a notification about a new text message, we wouldn’t know who this text message is from or what it says.
  • device’s battery status and whether the device is charging

To respect your privacy:

  • we do not access and do not record web browsing and search history
  • we do not access and do not record information about who you call and what you say
  • we do not access and do not record what you type
  • we do not access and do not record who you message and what the messages are
  • we do not access and do not record your message history
  • we do not access and do not record any videos or sounds
  • we do not access and do not record any videos or photos you take
  • we do not access and do not record what you do using the apps installed on your device, e.g., we do not record if you tap “like” on Facebook or if you buy any products using the Amazon app

Our research app will also ask you short questions, e.g., “Were you shopping yesterday?” On average, you would receive one question every two days and no more than three questions per day. By default, the questions will be sent between 11 am and 9 pm. However, you can change delivery times to be between the hours that you specify.

At the end of the first in-person meeting, we will schedule a phone call with you for three weeks later. This phone call is meant to see how you are doing with the app and whether you have any questions. We will check in again 2 months later and then schedule the second lab visit, 6 months after the first. The third lab visit will happen 12 months after the start of the study. The second and third lab visits will be similar to the first (thinking and movement tasks, EEG). During the third visit, we will remove the data collection app from your phone.

Finally, between in-person visits, we will ask you to complete brief (10-15 min) thinking tests at home at months 2, 4, 8, and 10.

Will I be compensated for my participation in this study?

As a token of our gratitude, after every session you will receive a check or gift card from a store of your choice: Amazon, Target, Bed Bath and Beyond, Walmart, Star Market, Stop & Shop, or iTunes. If you are interested in a gift card for another store, please let us know. We will do our best to accommodate your request, but we can’t guarantee that we will be able to provide gift cards for stores other than Amazon, Target, Bed Bath and Beyond, Walmart, Star Market, Stop & Shop, and iTunes.

You will receive:

  • $75 after the first lab session,
  • $95 after the second lab session,
  • $150 after the third lab session.

Participants who complete the whole study will receive a bonus of $180. Therefore, if you complete the whole study, you will receive a total of $500.

Completing the study means that you:

  1. participated in all three lab visits;
  2. completed brief thinking tests at home at months 2, 4, 8, and 10; each thinking test takes only 10-15 min;
  3. answered at least 75% of the short questions sent to your phone;
  4. and kept the data collection app installed and working on your phone for 12 months.

Where will this study take place and how much of my time will it take?

The lab sessions will take place in our lab at Northeastern University’s Interdisciplinary Science & Engineering Complex located at 805 Columbus Avenue in Boston. We will cover your parking fees. Click here to see the lab’s location on Google Maps.

The study will last 12 months from your first lab session to completion. Each of the three lab sessions will take between 2 and 3 hours. The lab visits will be six months apart.

At what times will the lab sessions take place?

We will schedule the lab meetings based on your availability. Our labs are open seven days a week between 8 am and 11 pm ET.

Who will see the information about me and my data?

Your information in this study will be confidential. Only the researchers conducting this study will see the information about you and your data. No reports or publications will use information that can identify you in any way as being a participant in this project. Your de-identified information could be used for future research without additional informed consent.

Can I stop my participation in this study?

Your participation in this research is completely voluntary. You do not have to participate if you do not want to, and you can refuse to answer any question. Even if you agree to be in the study, you may stop at any time. If you do not participate or if you decide to quit, you will not lose any rights, benefits, or services that you would otherwise have.

Will there be any risk or discomfort to me?

The likelihood and degree of risk to participants are minimal. You are also free to stop your participation at any time.

The possibility of feeling uncomfortable working with the app is very low. If you feel the questions sent by the app are annoying or distracting, you can place your phone on “silent” mode, or ignore them if they come at inconvenient times. You should ignore all questions while driving a vehicle.

You may feel fatigued or frustrated during the thinking and movement tasks in the lab. You will be allowed breaks at several points during each session.

EEG is of minimal risk and should cause no harm. There is a small chance that you may experience some scalp irritation from the electrodes.

Who can I contact if I have questions or problems?

If you have any questions about this study, please feel free to contact the principal investigator Dr. Sumientra Rampersad via phone (617-379-1112) or email: foci.study@gmail.com (preferred) or s.rampersad@northeastern.edu.