Epilepsy Clinical Trial
Official title:
First-in-human Experience Using Novel Ultraflexible Low-impedance Electrode Arrays: an IDEAL Stage 1 Study
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
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Great Ormond Street Hospital | London |
Lead Sponsor | Collaborator |
---|---|
Great Ormond Street Hospital for Children NHS Foundation Trust |
United Kingdom,
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 |
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