Experts look to establish guidelines for safe, ethical trials

With the rapid growth of brain-computer interface clinical trials in China — which account for nearly 40 percent of global research of the technology since 2020 — the need for uniform standards for indications, evaluation criteria, and pathway management has become increasingly apparent.

Medical experts are now creating the first guidelines for how and when to use implantable BCIs to help hospitals decide which patients are suitable for the treatment and how to conduct the trials safely and ethically.

These guidelines cover everything from the basic technology requirements to the detailed steps for evaluating patients, obtaining informed consent, and managing the treatment process.

According to the draft consensus seen by China Daily, patients suitable for BCI treatment must meet strict criteria. They are typically adults aged between 18 and 60, or up to 65 for some in a stable medical condition. They must be mentally clear, cognitively sound, and be able to undertake training. Their physical condition also needs to have been stable for at least six months.

The rules are even more specific based on the cause of paralysis. For instance, for spinal cord injury patients, the injury must be at least six months old, and located at a specific level of the spine.

"Establishing these standards is crucial for clinical trial design, medical access, and insurance reimbursement," said a BCI expert, who was involved in the consensus discussions.

BCI clinical trials cover the cost of surgery and devices.

However, families of paralyzed patients — including those with amyotrophic lateral sclerosis, or ALS — said they still face other major financial burdens.

"BCI would help her communicate better — that's hope," said Chen, a paralyzed patient's husband in Henan province. "But the caregivers, the ventilator, the medicines — none of that goes away. We still have to afford them tomorrow."

Li Wenjuan, a senior social worker who organizes patient support groups, said: "A full-time caregiver in major Chinese cities may cost 6,000 to 9,000 yuan ($846 to $1,269) per month. In cities like Beijing and Shanghai, caregiver wages can climb even higher."

For many families, this cost alone exceeds their total annual household income.

"We pay 8,000 yuan every month for a caregiver, and that's considered normal," said Wang Qian, whose husband was diagnosed with ALS three years ago. "I tried to balance working and taking care of him at the same time, but it was not possible. So I had to quit my job. We have lost over half our income in the past three years."

"It feels like the disease is eating our savings faster than it's eating his muscles," Wang said.

Although ALS has no cure, two drugs — riluzole and edaravone — are commonly prescribed to slow its progression. After partial reimbursement through national insurance, out-of-pocket spending for medication typically ranges from 50,000 to 80,000 yuan per year, depending on local policies and the frequency of treatment cycles, according to a 60-year-old male patient who lives in Hebei province.

"Even with insurance, we spend almost 7,000 yuan a month on medications, supplements, and hospital visits," he said.

These numbers align with estimates published by regional health authorities and patient foundations, which consistently list medication as the second-largest expense after caregiving.

ALS patients also rely on an expanding set of devices as the disease progresses. A basic electric wheelchair costs 2,000 to 6,000 yuan on JD, the online shopping platform. A non-invasive ventilator is typically above 3,000 yuan. A cough-assist machine can add another 20,000 yuan to medical bills.