About the Study


Investigator Contact Information:

Ian McClendon
Tel: (404) 641-7712
Email: imcclendon@gatech.edu

Melody Moore Jackson
(404) 385-7510
Email: melody@cc.gatech.edu

 

Important Documents:

Particpant Consent Form

User Manual -revised 5/12/09

Side Effects Reporting Form

 

Chat with an investigator

Secondary Chat

*Please attempt to use the primary chat first. Occasionally, the primary chat doesn't work. If this is the case, please attempt to connect using the secondary chat. Please note that the host of the chat must be online in order for you to chat in realtime.

Community Blog

 

Information for Participants

Possible 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.

Possible Risks

The device may not work for you.

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.

You must fully understand the possible risks and side effect during the informed consent process.

Participant’s Rights

The US Food and Drug Administration has carefully written rules about what must be done to protect the safety and privacy of participants. According to federal regulation, every clinical trial must be approved and monitored by an Institutional Review Board (IRB). This independent committee of doctors, nurses, and others is charged with ensuring that the trial is ethical and that the rights of participants are properly protected.

 

Informed Consent

The very first activity when one is considering participation in the study is to read and discuss information about the study. The participat consent form outlines all these important facts. You should have ample opportunity to read this form and ask questions. Once you fully understand the terms of the subject, you will be asked to sign the informed consent form.

Kokoro Gatari Headband

 

FAQ's:

Click here for a list of frequently asked questions.

 

Side Effects Procedure

If minor side effects are experienced, please complete the Side Effects Reporting form in the right column, and email the form to study investigators at imcclendon@gatech.edu. If more serious serious side effects are experienced, please immediately contact your physician, and then study investigators.