Clinical trial
A study in which a new drug or medical device is used in people to establish, step by step, that it is safe and that it works.
For a medical device, an early study in a handful to a dozen or so people first checks that it can be used safely; a larger trial then sets out to demonstrate the benefit statistically. Because approval hinges on the latter, it is called the pivotal trial[1]. Unlike drugs, devices are hard to compare against a sham operation, so the design of the comparison is itself a challenge.
For a brain-computer interface placed inside a blood vessel, an early study reported in 2023 that four patients went a year without serious device-related adverse events[2]. That shows the device can be left in place safely; showing how much it improves daily life is the task of the next stage. There is a long way between success in a few people and proof that something works for many.
Related terms
- Randomized controlled trialA trial that assigns participants by lot to receive a treatment or not, and compares outcomes, so that the treatment's effect can be measured without bias.
- Brain-computer interfaceTechnology that reads the brain's electrical signals and turns them into control of a computer or machine. Abbreviated BCI.
- StentrodeA device that mounts electrodes on a stent — a mesh tube used to hold blood vessels open — and delivers it through the neck to a vein near the brain, reading brain signals through the vessel wall.
Sources
- O. Faris, J. Shuren, “An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials,” N. Engl. J. Med. 376, 1350–1357 (2017).
- P. Mitchell, S. C. M. Lee, P. E. Yoo, et al., “Assessment of Safety of a Fully Implanted Endovascular Brain-Computer Interface for Severe Paralysis in 4 Patients,” JAMA Neurol. 80(3), 270 (2023).