Novel Network Analysis of Intracranial Stereoelectroencephalography

NCT03916848 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-11-19

No results posted yet for this study

Summary

Epilepsy is a disorder of the brain which is associated with disabling seizures and affects 100,000 people under 25. Many children with epilepsy also have a learning disability or problems with development. Although better outcomes occur in children who are successfully treated early for their epilepsy, 25% continue to have seizures despite best medical treatment.

One potential treatment is a neurosurgical operation to remove parts of the brain that generate seizures. A proportion of these children have electrodes inserted into their brains as part of their clinical assessment, termed stereoelectroencephalography (SEEG), to help localise these regions. Subsequent surgery is not always successful - up to 40% of children will have ongoing seizures 5 years after surgery.

The purpose of this study is to assess the utility of specially designed SEEG electrodes which can measure signals from single brain cells. These electrodes record the same clinical information as normal SEEG electrodes and are implanted in the same way, but can give the research team extra information at the same time. The investigators aim to assess whether studying the changes in the firing of individual cells, both during and between seizures, improves our ability to localise seizures and therefore improve outcomes following surgery.

As part of this research project, the investigators will not be doing anything that is not already part of the normal investigation and treatment for these children. Children will be recruited to the study during routine outpatient clinic visits. Surgical planning and execution will not be affected. The electrodes are CE licensed for clinical use and do not alter the risks of the operation. Following the period of monitoring, the care of these children would not be altered in any way.

The investigators aim to recruit 30 patients over 3 years. In addition to dissemination via scientific publications and presentations, the findings will be shared with participants and the public.

Conditions

  • Epilepsy in Children
  • Focal Epilepsy
  • Epilepsy Intractable
  • Epilepsy, Focal
  • Intractable Epilepsy
  • Refractory Epilepsy
  • Epilepsies, Partial

Interventions

PROCEDURE

Combined Micro-Macro SEEG Electrodes

The novel combined micro-macro electrodes will then be used during the surgical implantation procedure. The use of these novel electrodes will not change the surgical procedure, which is conducted using robotic assistance to ensure optimal accuracy. The macro electrode recordings will be used for routine clinical analysis and the duration of recording and subsequent analysis of the recordings will not be affected by the micro electrode data captured for research purposes. The clinical SEEG also involves electrical stimulation of the brain which will not be affected by the study.

Sponsors & Collaborators

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Rod Scott, PhD · Great Ormond Street Hospital for Children NHS Foundation Trust

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-16
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • United Kingdom

Study Locations

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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 NCT03916848 on ClinicalTrials.gov