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

NCT06116279 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-11-03

No results posted yet for this study

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

Conditions

Interventions

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.

Sponsors & Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Martin Tisdall, MD FRCS · Great Ormond Street Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-02-01
Completion
2025-08-01

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06116279 on ClinicalTrials.gov