Status:
UNKNOWN
First-in-human Experience Using Novel Ultraflexible Low-impedance Electrode Arrays: an IDEAL Stage 1 Study
Lead Sponsor:
Great Ormond Street Hospital for Children NHS Foundation Trust
Conditions:
Epilepsy
Focal Cortical Dysplasia
Eligibility:
All Genders
3-18 years
Phase:
NA
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 dysplas...
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. Ne...
Eligibility Criteria
Inclusion
- 1\. Radiologically visible epileptogenic lesion (focal cortical dysplasia or long-term epilepsy associated tumour) undergoing planned resective surgery
Exclusion
- 1\. Unable to provide informed consent
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06116279
Start Date
February 1 2024
End Date
August 1 2025
Last Update
November 3 2023
Active Locations (1)
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1
Great Ormond Street Hospital
London, United Kingdom, WC1N 3JH