NCT06368310

FIH Clinical Investigation of Graphene Electrodes for Brain Mapping

Recruiting now NA Last updated 25 March 2026

What this trial tests

NA trial testing INBRAIN Graphene Cortical Interface in Brain Tumor in 10 participants. Currently enrolling.

Timeline

6 August 2024

Primary endpoint
24 June 2026

24 June 2026

Quick facts

Lead sponsor	University of Manchester
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	device feasibility
Enrollment	10
Start date	6 August 2024
Primary completion	24 June 2026
Estimated completion	24 June 2026
Sites	1 location across United Kingdom

Drugs / interventions tested

• INBRAIN Graphene Cortical Interface

Conditions studied

• Brain Tumor — all drugs for Brain Tumor →
• Glioma — all drugs for Glioma →

Sponsor

University of Manchester

Who can join

18 and older, any sex, with Brain Tumor or Glioma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this clinical investigation of a medical device is to test the safety of graphene based electrodes when used during surgery for resection of brain tumors. The main questions that it aims to answer are:

* To understand the safety of the Graphene Cortical Interface when used during brain tumor surgery (primary objective);
* To assess the quality of the brain signals recorded with the Graphene Cortical Interface, their ability to stimulate the brain, how stable their function is over the duration of an operation, and their suitability for use in the operating theatre (secondary objectives).

Participants will undergo tumor surgery as usual with the study electrodes being tested alongside a standard monitoring system. If they are awake for part of their surgery they may be asked to complete specific tasks such as naming objects from a list modified for the study, to evaluate the capability to decode brain signals (exploratory objective). They will be monitored subsequently for any complications including undergoing an additional MRI scan 6 weeks after their surgery.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Pre-clinical Safety of Graphene-based Electrodes Implanted on Rat Cerebral Cortex.
   Kim G, Jeong H, Kim K, Lee S, et al · · 2025 · cited 1× · PMID 40983603 · DOI 10.5607/en25018
2. Concept of 2D van der Waals Nanohybrids for Key Biomedical Applications.
   Rejinold NS, Choy JH. · · 2026 · PMID 42039853 · DOI 10.2147/ijn.s559240
3. Editorial: Biointerfacing 2D nanomaterials and engineered heterostructures, volume II.
   Gravagnuolo AM, Martucci A, Morales-Naváez E. · · 2024 · PMID 39758952 · DOI 10.3389/fbioe.2024.1542498