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Novel Network Analysis of Intracranial Stereoelectroencephalography (NNAIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916848
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : June 24, 2019
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Brief 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.


Condition or disease Intervention/treatment Phase
Epilepsy in Children Focal Epilepsy Epilepsy Intractable Epilepsy, Focal Intractable Epilepsy Refractory Epilepsy Epilepsies, Partial Procedure: Combined Micro-Macro SEEG Electrodes Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Novel Network Analysis of Intracranial Stereoelectroencephalography
Actual Study Start Date : June 16, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : January 2022


Arm Intervention/treatment
Experimental: Combined Micro-Macro SEEG Electrodes
Implanting SEEG electrodes with combined micro-macro electrodes capable of recording clinical data and experimental micro electrode single unit data
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.




Primary Outcome Measures :
  1. Analyse single unit behaviour in different brain regions. [ Time Frame: Recording will continue for a period of 5-10 days, as determined by the clinical team. We will therefore use the data collected over the entire recording period for analysis. ]

    We will assess the abnormalities in single neuron firing behaviour both during and between seizures in children undergoing stereoelectroencephalogaphy (SEEG) as part of work-up for epilepsy surgery.

    The statistical analysis will include measures of timing coding and population coding of these single units and the investigators will assess these properties in time periods both during and between seizures to assess whether neurons in the seizure onset zone behave differently to those outside the seizure onset zone:

    1. Timing coding is evaluated using a generalized linear modeling (GLM) approach. An output of the GLM is called a post-spike filter (PSF), which models the propensity for the same neuron to fire again over the course of the subsequent 0.7 seconds.
    2. Population coding is also evaluated using a GLM by calculating coupling filters (the amount of up and down regulation of all other recorded neurons given that an individual neuron has just fired).

  2. Correlate firing activity of single units to the clinically defined seizure onset zone (SOZ) [ Time Frame: Recording will continue for a period of 5-10 days, as determined by the clinical team. We will therefore use the data collected over the entire recording period for analysis. ]

    Currently, the seizure onset zone (SOZ) is determined by visual analysis of the SEEG recordings at the end of the monitoring period.

    We aim to compare the differences in single unit behaviour (as defined above) between and during seizures in neurons inside and outside this clinically defined SOZ to assess if there is a unique behaviour to these neurons.




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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Undergoing SEEG recording as part of the investigation of their epilepsy at Great Ormond Street Hospital for Children
  • Aged 3-18
  • Participant/parents provide informed consent for inclusion

Exclusion Criteria:

  • Lack of informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916848


Contacts
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Contact: Aswin Chari, MRCS +447726780817 aswin.chari@gosh.nhs.uk
Contact: Rod Scott, PhD +447726780817 Rodney.Scott@uvmhealth.org

Locations
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United Kingdom
Great Ormond Street Hospital NHS Foundation Trust Recruiting
London, United Kingdom, WC1N 3JH
Contact: Aswin Chari, MRCS    +447726780817    aswin.chari@gosh.nhs.uk   
Contact: Rod Scott, PhD    +447726780817    Rodney.Scott@uvmhealth.org   
Principal Investigator: Rod Scott, PhD         
Sub-Investigator: Martin Tisdall, MD         
Sub-Investigator: Rachel Thornton, PhD         
Sub-Investigator: Aswin Chari, MRCS         
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
Investigators
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Principal Investigator: Rod Scott, PhD Great Ormond Street Hospital for Children NHS Foundation Trust
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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03916848    
Other Study ID Numbers: 18NM09
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: June 24, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Currently no provision for IPD sharing, will need further ethical approvals to do this.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:
Stereoelectroencephalography
Single unit recording
Single neuron recording
SEEG
Epilepsy surgery
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases