Frequently Asked Questions:

What can I say with the device?
How long will the study last?
What percentage of subjects are able to use the device?
How will investigators determine if I will continue in the study?
What are the risks?
What are the benefits?
How will investigators keep my information private?
Are there any costs to me?
Do I own the device?
Who can participate?
How do I enroll in the study?
What are my rights as a subject?

1) What can I say with the device?

The device is intended to allow users to communicate “yes” and “no”, using only brain activity.

2) How long will the study last?

The overall study with all participants may take up to one year.   Initially, you will try the device for one month, but there may be a possibility that you could use it longer.

3) What percentage of subjects are able to use the device?

In previous studies, the Kokoro Gatari device worked for about half of the participants

4) How will investigators determine if I will continue in the study?

After an initial one-month testing period, Investigators will evaluate how well the Kokoro Gatari device works for you.  You may be asked to continue in the trial for another 3 months, or the trial may end after one month.

5) What are the risks?

Some people may experience minor discomfort as a result of wearing the sensor-mounted headband for long periods of time.  You should not wear the headband for more than 60 minutes at a time.  If you have a fever, you should not use the device because of a very slight risk of low-temperature burns from the infrared light.   If you feel any discomfort whatsoever, you should let your caregiver know, and stop using the device immediately. 

6) What are the benefits?

With the help of this device, you could find it easier to communicate with your family and caregivers.  The Kokoro Gatari is an investigational device which has been effective for a little more than half of the ALS patients who have participated in the previous study.   The device may not work for you, but this does not mean anything about your mental ability or your health.  Even if the device does not work for you, you will help us to make the device better by participating in the study. 

7) How will investigators keep my information private?

We will follow these procedures to keep your personal information confidential in this study: The data that we collect about you will be kept private to the extent allowed by law. To protect your privacy, we will keep your records under a code number rather than by your name. We keep all of our records in locked files and only study staff will be allowed to look at them. Your name and any other facts that might point to you will not appear when we present or publish the results of this study. If we transcribe audio or video recordings, they will be used only for research purposes and we will remove all identifying information. Your privacy will be protected to the extent allowed by law.    The Office of Human Research Protections and/or the Food and Drug Administration may also look over study records during required reviews. The sponsor of this study, Hitachi and/or ALS Association have the right to review study records as well.

To make sure that this research is being carried out in the proper way, the Georgia Institute of Technology Institutional Review Board (IRB) may review study records.

8)Are there any costs to me?

There is no cost to you for participating in this study.

9) Do I own the device?

No, the ALS association retains ownership of the device and equipment throughout the duration of the study.  The device and equipment must be returned at the conclusion of the study.   

10) Who can participate?

ALS patients who meet inclusion criteria and to whom the exclusion criteria does not apply. Your physician will determine whether or not you are a potential participant. Please see below for the inclusion/exclusion crieteria.

Inclusion Criteria – these are criteria that you must meet in order to participate in the study.

• People with ALS who are alert and can hear their caregiver’s questions and understand the meaning of such questions. 
• Participants who can indicate at least “YES” or “NO” by some method such as subtle eye movements, blinking, or using an AAC device in response to caregivers’ questions.  This will allow investigators and caregivers to monitor for adverse events.
• Primary physician’s approval for participation of their ALS patients in the study.  Family members may obtain verbal approval from the physician and must certify that approval was given.  The physician should determine the acceptable range of temperature and blood pressure for each participant.

Exclusion Criteria

• A history of cerebrovascular diseases (such as stroke).
• Hypertension (acceptable blood pressure to be determined by the primary care physician)
• Peripheral circulation insufficiency.
• Inability to answer “yes” and “no” in some way.

11) How do I enroll in the study?

Please contact the study invetigators using the contact information at the top of the right column, or the request more information form on the Enroll page of this website.

12) What are my rights as a subject?

• Your participation in this study is voluntary. You do not have to be in this study if you don't want to be.
• You have the right to change your mind and leave the study at any time without giving any reason, and without penalty. We will ask you if you would like to continue in the study between every trial.
• We will give you any new information that may make you change your mind about being in this study.
• You will get a copy of this consent form to keep.
• You do not waive any of your legal rights by signing the participant consent form.

If you have a question that is not answered here, please use the contact information in the top of the right column to contact an investigator or use the chat feature, also located in the right column.