First-in-human Experience Using Novel Ultraflexible Low-impedance Electrode Arrays: an IDEAL Stage 1 Study

Epilepsy Clinical Trial

Official title:

First-in-human Experience Using Novel Ultraflexible Low-impedance Electrode Arrays: an IDEAL Stage 1 Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06116279
• Other study ID #: 21BI27
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2024
• Est. completion date: August 1, 2025

Study information

• Verified date: November 2023
• Source: Great Ormond Street Hospital for Children NHS Foundation Trust
• Contact: Martin Tisdall, MD FRCS
• Phone: 07726780817
• Email: martin.tisdall[@]gosh.nhs.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: August 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Focal Cortical Dysplasia

Intervention

Device:
• Insertion of electrode during planned neurosurgery for epilepsy
A novel, 300 micrometer, ultraflexible, low-impedance electrode proposes to cause minimal parenchymal (brain tissue) damage, and provide multiple contacts at multiple depths to allow unit-level recordings for a period of 15 minutes.

Locations

Country	Name	City	State
United Kingdom	Great Ormond Street Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of novel electrode into current operative workflow	Document total length of set up and recording with electrode (recorded in minutes)	At operation
Secondary	Resected tissue assessed histologically for damage from novel electrode	Neuropathologists will perform haematoxylin and eosin histological (H&E), luxol fast blue, and neutral red to describe the insertion tract lesion and neocortical cytoarchitecture	4 weeks following operation
Secondary	Analysis of recorded electrophysiological data from intraoperative recording by novel electrode	The data obtained from intraoperative recording will be analysed by computational neuroscientists	6 months
Secondary	Safety of novel electrode insertion and recording	Intraoperative events occur (haemorrhage, seizure, stroke)	At operation