Experimental brain implants are on the rise. What happens after the trials are over?

In 2024, Elon Musk's Neuralink implanted its first brain chip in a human, amid controversy over animal testing. Two and a half years later, over 20 "neuralnauts" are using these devices to interact with the digital world. These brain implants are getting smaller, more compatible with the human body, and more powerful. They are now being used to restore speech in paralyzed individuals and even control both robotic and natural limbs simultaneously.

As the industry grows, more clinical trials involving implanted devices are expected. However, the end of a trial raises important questions about what happens next for the participants. There's no clear answer, as some may continue to use the device "off-label" or join a follow-up study funded by the trial sponsor. But if the sponsor is funded by grants or venture capital, they might not be able to cover the costs of lifelong device support.

Participants might have to have their device removed at the end of the trial even if it has benefited them. This is a real concern in Australia, where new neurotech companies are emerging. One company, EpiMinder, received FDA approval for a continuous seizure monitoring system for epilepsy, while Synchron raised over A$300 million for a minimally invasive endovascular brain-computer interface and is starting a new trial in Australia.

There are no clear rules in Australia about how long-term support for trial participants should be handled. The Australian clinical trial handbook asks researchers to explain if participants will have continued access, but this is difficult as trial durations are often several years. This makes it hard for participants to plan for their future needs and preferences once the trial ends.

An expert panel of 24 professionals was brought together to develop recommendations on post-trial responsibilities in Australia. If trial sponsors can provide options for continued use, we recommend giving participants and their loved ones a clear picture of what continued use would entail. This includes who will provide clinical and technical support, whether surgery and maintenance will be covered by public healthcare or private insurance, and what costs participants might face themselves.

Participants should also receive updates on changes to funding, regulatory status, or commercial plans that could affect their ongoing care. However, this transparency is not always guaranteed in neurotechnology research. The panel also recommends considering geographic and socioeconomic barriers to continuing device use. Trials are often conducted at metropolitan teaching hospitals, and participants may need to make repeated visits or travel interstate.

This can complicate access to local care, particularly as laws around psychosurgery vary between states. The panel suggests anticipating these barriers during recruitment and study design, engaging participants' primary treating physicians to discuss what aspects of post-trial support can be taken on locally. Some procedures may still require specialist expertise, but sharing post-trial support could reduce travel costs and dependence on the original research team.

Ultimately, the end of a clinical trial should not mean losing access to a device. Better planning and coordination between trial organizers could ensure continued use is possible. Participants are pioneers who have put their brains in researchers' hands to help develop new treatments, and they deserve better support when their trials end.