Clinical trial NCT06116279: First-in-human Experience Using Novel Ultraflexible Low-impedance Electrode Arrays: an IDEAL Stage 1 Study
Official title: First-in-human Experience Using Novel Ultraflexible Low-impedance Electrode Arrays: an IDEAL Stage 1 Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Epilepsy
Focal Cortical Dysplasia
Keywords: Epilepsy
FCD
LEAT
Neurosurgery
Microelectrode
Local field potential
Epileptic zone
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 6
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The investigators will adhere to the internationally accepted five-stage Idea, Development, Evaluation, Assessment, Long-term study (IDEAL) framework for novel surgical device innovation. An IDEAL Stage 1 study requires a highly-selected patient group (n=6) and focuses on novel device innovation feasibility and safety. Adhering to the IDEAL framework will facilitate the development and evaluation of the novel device in a logical manner that balances innovation and safety.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this first-in-human study is to evaluate a novel ultraflexible microelectrode in children undergoing neurosurgery to remove tissue that causes epilepsy (seizures) in focal cortical dysplasia (FCD) or long-term epilepsy-associated tumours (LEAT).

The main questions it aims to answer are:

1. The safety and feasibility of the novel microelectrode into current operative workflow
2. The unique electrophysiological tissue signatures in FCD or LEAT

Detailed description: Epilepsy affects 100,000 people under 25. Many children with epilepsy also have a learning disability or developmental problems and 25-30% continue to have seizures despite best medical treatment.

Neuromodulation or brain stimulation is the delivery of electricity to the brain cells. It may alter the brain activity and overall brain connectivity and currently is rarely used as a treatment for epilepsy. However, it has the potential to reduce the number of seizures and improve other problems that children with epilepsy may have such as concentration, memory and learning. 'Precision neuromodulation', which involves individually tailored treatments requires us to identify where in the brain to stimulate and what the best settings are in each individual. A limitation of current neuromodulation treatment is limited understanding of the abnormal signatures of electrical activity in abnormal tissue.

The investigators have developed a novel electrode that can record signals from the brain at higher resolution than current electrodes. The 2 micrometer, ultraflexible, low-impedance electrode arrays are smaller, less damaging, and provide multiple contacts at multiple depths. The investigators propose a first-in-human study to investigate the feasibility and safety of using these electrodes in patients undergoing surgery for epilepsy - either focal cortical dysplasia (FCD) or long-term associated epilepsy tumours (LEAT).

The investigators will insert the electrode into brain tissue that is going to be removed as part of the planned surgery. The extent of tissue damage caused by insertion will be examined, and whether the electrode is able to capture signals at difference scales from the brain will be assessed; this includes signals from an area of tissue (termed local field potential) and signals from single nerve cells (termed single unit recordings). If safe, it will lay the foundation to use these electrodes in future precision neuromodulation platforms that can be applied to epilepsy and other neurological diseases.

Eligibility criteria: Inclusion Criteria:

1. Radiologically visible epileptogenic lesion (focal cortical dysplasia or long-term epilepsy associated tumour) undergoing planned resective surgery

Exclusion Criteria:

1. Unable to provide informed consent

Primary outcomes:
measure: Feasibility of novel electrode into current operative workflow
timeFrame: At operation
Secondary outcomes:
measure: Resected tissue assessed histologically for damage from novel electrode
timeFrame: 4 weeks following operation
measure: Analysis of recorded electrophysiological data from intraoperative recording by novel electrode
timeFrame: 6 months
measure: Safety of novel electrode insertion and recording
timeFrame: At operation
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
Study officials:
affiliation: Great Ormond Street Hospital
name: Martin Tisdall, MD FRCS
role: PRINCIPAL_INVESTIGATOR
References: