What is First-in-Human?

The initial clinical study in which a new medical device or therapy is used in a human participant for the first time, following extensive preclinical testing in animal models and bench studies.

What category does First-in-Human belong to in BCI?

First-in-Human is a Regulatory concept in brain-computer interface science.

First-in-Human — BCI Glossary

A first-in-human (FIH) study is the critical milestone at which a new medical device transitions from animal testing and laboratory bench work to initial use in a human patient. For implanted BCI devices, the FIH study represents years of engineering development, preclinical validation, and regulatory preparation culminating in the first surgical implantation in a person. FIH studies are typically small (1-5 participants), heavily monitored, and primarily focused on safety assessment.

Regulatory Requirements

Before a BCI FIH study can proceed, the sponsor must obtain:

IDE approval from the FDA: Demonstrating sufficient preclinical safety data (animal studies, bench testing, biocompatibility per ISO 10993) to justify human use
IRB approval: Institutional Review Board review of the study protocol, informed consent documents, and risk-benefit assessment
Informed consent: Comprehensive participant consent covering all known risks, potential benefits, and alternatives

Landmark BCI First-in-Human Studies

BrainGate (2004): Matthew Nagle, a 25-year-old man with tetraplegia from a spinal cord injury, received the first implanted intracortical BCI — a Utah Array in motor cortex. He demonstrated cursor control and rudimentary device operation.
Synchron Stentrode (2019/2021): First endovascular BCI implanted in humans — in Melbourne, Australia (2019) and the US (2021). Demonstrated that a stent-mounted electrode array in the superior sagittal sinus could record motor cortex signals without craniotomy.
Neuralink N1 (2024): First human implant of Neuralink's 1,024-channel wireless BCI (PRIME study). Participant Noland Arbaugh demonstrated high-performance cursor control.
ONWARD ARC-IM (2023): First use of a brain-spine digital bridge — cortical BCI recordings controlling epidural spinal stimulation to restore walking after paralysis.

FIH Study Design

FIH BCI studies are typically single-arm, open-label, with no control group. The primary endpoints are safety (adverse events, device-related complications) and feasibility (can the device record neural signals? can the participant achieve basic BCI control?). Efficacy endpoints are exploratory at the FIH stage — definitive efficacy assessment requires the subsequent pivotal trial.

Risk Management

FIH studies carry inherent uncertainty. Despite extensive preclinical testing, novel failure modes can emerge in humans. BCI FIH studies include detailed surgical safety protocols, 24/7 monitoring during the initial post-implant period, and predefined stopping rules for serious adverse events. The small cohort size means that rare complications may not be detected until later, larger studies.