Application — Cortical surface
Graphene micro-ECoG first-in-human brain-mapping study (NCT06368310)
Lab or organization
Graphene micro-ECoG first-in-human study (NCT06368310)
The registered first-in-human study of INBRAIN’s graphene cortical interface, used intraoperatively during brain tumor resection. Registry facts are from ClinicalTrials.gov (verified October 24, 2026); outcome figures are company-reported and labeled as such.
Study facts
| Field | Value and source scope |
|---|---|
| Registry | NCT06368310; interventional, single-group, device feasibility, no masking [1] |
| Official title | First in Human (FIH) Clinical Investigation of Safety and Feasibility of a Novel Graphene Micro-electrocorticography Array for Brain Mapping in Neuro-oncology [1] |
| Sponsor and site | University of Manchester; Manchester Centre for Clinical Neurosciences, Northern Care Alliance NHS Foundation Trust, Salford, United Kingdom [1]; chief investigator David Coope per the company release [2] |
| Status | Completed: actual start August 6, 2024, actual completion June 24, 2026 [1] |
| Enrollment | 10 (actual) [1]; company-reported: 10 recruited, 8 treated surgically, complete datasets from 8 [4] |
| Conditions | Brain tumor, glioma [1] |
| Primary outcome | Preliminary safety of the device for its intended use, assessed through study completion (average 3 months) [1] |
| Secondary outcomes | Ability to record brain signals; ability to provide functional stimulation; stability of sensing and stimulating electrodes [1] |
| Company-reported results | No device-related adverse events in the first four patients [2]; no device-related adverse events in all eight surgically treated patients up to surgical discharge and no perioperative device failure [4]. During awake language mapping the device captured distinct high-gamma activity linked to different phonemes [2] |
| First human application | Announced September 27, 2024 per ICN2 [3] |
Primary sources
- ClinicalTrials.gov, NCT06368310. Verified October 24, 2026.
- INBRAIN interim analysis release, Business Wire, July 28, 2025. Company press release.
- ICN2, first human application, September 27, 2024.
- INBRAIN enrolment completion release, Business Wire, April 20, 2026. Company press release.