This page provides information to help physicians to make medically informed decisions as to whether or not their patients would be a good candidate for participation in the Kokoro Gatari Study.

Physicians are asked to recommend normal body temperature (taken by ear) and normal body temperature for subject.

Physicians are also asked to certify that the study exclusion criteria does not apply to the subject.

Physicians should also be aware that although the risk of low temperature burn is very low with the Kokoro Gatari device, the manufacturer recommends that device not be used if the subject has a fever.

Below are the inclusions/exclusion criteria for the Kokoro Gatari Study:

Inclusion/Exclusion Criteria

       Inclusion Criteria

1. People with ALS who are alert and can hear their caregiver’s questions and understand the meaning of such questions. 
2. 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 any possible side effects.
3. 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 on the consent form.




Exclusion Criteria

1. A history of cerebrovascular diseases.
2. Hypertension.
3. Peripheral circulation insufficiency.
4. Inability to answer “yes” and “no” in some way.

 

Listed in the right column are links to the Participant Consent Form, the Nonsignficant Risk Device Letter, the Caregiver Teaching Plan, the Device User Manual, and the Side Effects Reporting Form.