Giving Consent in a World With Limited Communication Ability

Saturday - August 26 2023, 23:21 UTC - 1 year ago

This article looks at the challenges of consenting a BCI therapy trial, particularly for patients who have limited or no communication ability. It looks at the different methods that have been suggested, and how the RSV vaccine and new treatment for spinal cord injuries are making positive changes in the field.

The participant in the first study, Pat Bennett, lost her ability to speak as a result of ALS, also known as Lou Gehrig’s disease, a devastating illness that affects all the nerves of the body. Eventually it leads to near-total paralysis, so even though people can think and reason, they have almost no way to communicate. The other study involved a 47-year-old woman named Ann Johnson, who lost her voice as the result of a brain-stem stroke that left her paralyzed, unable to speak or type .

Both these women can communicate without an implant. Bennett uses a computer to type. Johnson uses an eye-tracking device to select letters on a computer screen or, often with her husband’s help, a letterboard to spell out words. Both methods are slow, topping out at about 14 or 15 words a minute, but they work.People who especially stand to benefit from this type of research are those with locked-in syndrome (LIS), who are conscious but almost entirely paralyzed, without the ability to move or speak .

Some can communicate with eye-tracking devices, blinks, or muscle twitches. Making sure trial participants give informed consent is always important, but communication struggles make the process tricky. Ramsey’s group has been working with patients with ALS for years, and they’re one of a few teams working with patients who have extremely limited communication abilities. In 2016, they reported that they had developed a system that allowed a woman with ALS to use her mind to perform a mouse click .

By the end of the study, she could select three letters per minute. "That person has used it for seven years, and she used it day and night to communicate when she couldn’t use any other means anymore," he says. Now, Ramsey and his colleagues are working with other individuals in an attempt to translate brain activity into speech. But people who are dependent on others for their care and communication needs are in a particularly vulnerable spot .

In one paper, researchers point out that the desire to consent might be influenced by how a patient’s decision would affect family members and caregivers. "If an implantable BCI trial or therapy offers the prospect of changing the character or degree of dependency on others, a [person with ALS] may feel obligated to pursue a BCI. Depending on the nature of this felt obligation, the voluntariness of the decision to have a BCI implanted may come into question .

"Ramsey’s group doesn’t work with patients who are completely locked in, unable to communicate via any voluntary movement or noise. But he says there are potentially ways to get consent with the help of a functional MRI scanner. "They have to perform a simple task like reading words or counting backwards," he says. "Simple tasks that we know work in everyone who is awake." If the data shows the person isn’t performing those activities, the researchers assume that "either the person is not able to follow instructions or the person doesn’t want to participate and tells us so by deliberately not doing the task .

" A bit of good news heading into the fall. The FDA approved the new RSV vaccine for pregnant women, and they’ve also approved a new treatment for spinal cord injuries.