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

NCT06116279 | Unknown DMC

• 1 other identifier: 21BI27
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Conditions

Epilepsy; Focal Cortical Dysplasia

Keywords

Epilepsy; FCD; LEAT; Neurosurgery; Microelectrode; Local field potential; Epileptic zone

Outcome Measures

Primary Outcomes (1)

• Feasibility of novel electrode into current operative workflow

  Document total length of set up and recording with electrode (recorded in minutes)

  At operation

Secondary Outcomes (3)

• Resected tissue assessed histologically for damage from novel electrode

  4 weeks following operation

• Analysis of recorded electrophysiological data from intraoperative recording by novel electrode

  6 months

• Safety of novel electrode insertion and recording

  At operation

Study Arms (1)

Insertion of electrode during planned neurosurgery for epilepsy

EXPERIMENTAL

During the surgical procedure, following exposure of the brain via a craniotomy, the novel electrodes will be inserted into tissue planned for resection. This will be targeted using the existing neuronavigation software that is being used during the surgery and may be augmented by intraoperative ultrasound, also a common adjunct used in these surgeries. Following insertion of the electrode, the cables will be connected to a specialised (portable) amplifier inside the operating theatre and 15 minutes of data will be recoded. The electrodes will then be removed and the surgical resection will then proceed as planned. The content of the recordings will not be available in real-time and will not be used to inform or change the surgical resection plan in any way.

Device: Insertion of electrode during planned neurosurgery for epilepsy

Interventions

Insertion of electrode during planned neurosurgery for epilepsy DEVICE

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.

Insertion of electrode during planned neurosurgery for epilepsy

Eligibility Criteria

• Age: 3 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \. Unable to provide informed consent

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Conditions

Epilepsy; Focal Cortical Dysplasia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Martin Tisdall, MD FRCS

  Great Ormond Street Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Tisdall, MD FRCS

CONTACT

07726780817; martin.tisdall@gosh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: November 3, 2023
• Study Start: February 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 3, 2023

Record last verified: 2023-11

Locations

GB (1)