Coherence Neuro announced that it has started the first-in-human clinical trial of its investigational Cipher brain-computer interface (BCI). The study opened under the leadership of Dr. Andrew Morokoff at Royal Melbourne Hospital and will test the system during brain tumor resection surgery.

The Cipher system is described by the company as bi-directional — it both records cortical activity and delivers electrical stimulation. Coherence says Cipher uses a flexible, electrode-dense thin-film cortical probe intended to provide very high spatial resolution for sensing and stimulation.

The initial trial will evaluate the device’s use for intraoperative neurophysiological mapping and stimulation during tumour resections. The company said the study is designed to assess safety, basic performance and handling characteristics during short-duration, intraoperative use.

Findings from this first-in-human work will inform development of SOMA-1, Coherence’s second-generation implantable therapeutic BCI. The company describes SOMA-1 as a coin-sized wireless implant that would continuously record and deliver tailored stimulation in the tumor microenvironment. Coherence also plans an over-ear wearable to provide power and memory, and a companion app for real-time monitoring and session history, the company said.

Co-Founder and CEO Ben Woodington was quoted by the company: "While the transition to a clinical stage company is a phenomenal achievement, our real work is only just beginning. The team is on a mission to transform the lives of people with cancer, starting with the brain. We are developing the world’s first platform to record and modulate cancer in real time."

The company noted other firms, such as Novocure, have applied electrical fields to treat tumors using non-implantable methods. Coherence said it aims to develop an implantable therapy that continuously senses and stimulates in the tumor environment. Coherence raised a $10 million seed round last year, which the company said supported the move into clinical studies.

Dr. Morokoff previously performed early human implants for another BCI developer, Synchron, which the company highlighted when announcing trial initiation.

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Tags: brain-computer interface, cortical probe, brain tumor resection, therapeutic implant

Topics: Brain–computer interfaces, Neuroprosthetics & neural implants, Neuromodulation