20 January 2025 , 13:44
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Devices may have potential to help patients with conditions such as depression, addiction, OCD and epilepsy.
A groundbreaking NHS trial will attempt to boost patients’ mood using a brain-computer-interface that directly alters brain activity using ultrasound.
The device, which is designed to be implanted beneath the skull but outside the brain, maps activity and delivers targeted pulses of ultrasound to “switch on” clusters of neurons. Its safety and tolerability will be tested on about 30 patient in the £6.5m trial, funded by the UK’s Advanced Research and Invention Agency (Aria).
In future, doctors hope the technology could revolutionise the treatment of conditions such as depression, addiction, OCD and epilepsy by rebalancing disrupted patterns of brain activity.
Jacques Carolan, Aria’s programme director, said: “Neurotechnologies can help a much broader range of people than we thought. Helping with treatment resistant depression, epilepsy, addiction, eating disorders, that is the huge opportunity here. We are at a turning point in both the conditions we hope we can treat and the new types of technologies emerging to do that.”
The trial follows rapid advances in brain-computer-interface (BCI) technology, with Elon Musk’s company Neuralink launching a clinical trial in paralysis patients last year and another study restoring communication to stroke patients by translating their thoughts directly into speech.
However, the technologies raise significant ethical issues around the ownership and privacy of data, the possibility of enhancement and the risk of neuro-discrimination, whereby brain data might be used to judge a person’s suitability for employment or medical insurance.
Clare Elwell, professor of medical physics at UCL, said: “These innovations could be really fast-moving from a technical perspective, but we’re lagging behind on addressing neuroethical issues. We’re now accessing neural pathways in a way that we haven’t been able to do before, so we need to carefully consider the clinical impact of any intervention and ensure we always act in the best interests of the patient.”
The latest trial will test a device developed by the US-based non-profit Forest Neurotech. In contrast to invasive implants, in which electrodes are inserted into a specific location in the brain, Forest 1 uses ultrasound to read-out and modify activity. Aria describes the device as “the most advanced BCI in the world” due to its ability to modify activity across multiple regions simultaneously.
This widens potential future applications to a huge patient population affected by conditions such as depression, anxiety and epilepsy, which are all “circuit level” conditions rather than being localised in a specific brain region.
Aimun Jamjoom, a consultant neurosurgeon at the Barking, Havering and Redbridge university hospitals NHS trust, who is leading the project, said: “This is a less invasive technique and the ability to offer a safer form of surgery is very exciting. If you look at conditions like depression or epilepsy, [up to] a third of these patients just don’t get better. It’s those groups where a technology like this could be a life-changing solution.”
The NHS trial will recruit patients who, due to brain injury, have had part of their skull temporarily removed to relieve a critical buildup of pressure in the brain. This means the device can be tested without having to perform surgery.
When placed beneath the skull, or in individuals with a skull defect, ultrasound can detect tiny changes in blood flow to produce 3D maps of brain activity with a spatial resolution of about 100 times that of a typical fMRI scan. The same implant can deliver focused ultrasound to mechanically nudge neurons towards firing, providing a way to remotely dial activity up at precise locations.
Participants will wear the device on their scalp at the site of the skull defect for two hours. Their brain activity will be measured and researchers will test whether patients’ mood and feelings of motivation can be reliably altered.
There are safety considerations, as ultrasound can cause tissue to heat up. Prof Elsa Fouragnan, a neuroscientist at the University of Plymouth, which is collaborating on the project, said: “What we’re trying to minimise is heat. There’s a safety and efficacy trade-off.”
She added that it would also be important to ensure that personality or decision-making were not altered in unintended ways – for instance, making someone more impulsive.
The study will run for three and a half years starting from March, with the first eight months focused on securing regulatory approval. If successful, Forest hopes to move into a full clinical trial for a condition such as depression.
The Forest 1 trial is one of 19 projects announced on Monday as part of Aria’s £69m precision neurotechnologies programme, with others including research on neural robots for epilepsy treatment, genetic engineering of brain cells and lab-grown brain organoids. Aria, the UK’s equivalent of the US Defense Advanced Research Projects Agency (Darpa) and brainchild of Dominic Cummings, was established in 2023 with the mission of funding high-risk, high-reward scientific endeavours.