Investigating the Neuronal Bases of Epilepsy With Micro-electrode Arrays in Candidates for Epilepsy Surgery (IN-MAP)

Investigating the Neuronal Bases of Epilepsy With Micro-electrode Arrays in Patients Who Are Candidates for Epilepsy Surgery

This study aims to uncover the neuronal bases of epilepsy by recording the activity of single neurons in the brain of patients with epilepsy who are candidates for assessment with intracranial electroencephalography (EEG). A micro-electrode array will be inserted into the brain in addition to the standard intracranial EEG electrodes for up to 4 weeks.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Device: NeuroPort micro-electrode array

Detailed Description

Epilepsy is a disease characterized by the tendency to have seizures, which are thought to be due to excessive activity in the neurons of the brain. However, it is technically difficult to record the activity of neurons, especially in the brain of human patients. Therefore, there are gaps in what scientists know of what exactly goes wrong in neurons during epileptic seizures.

In this study, an array of micro-electrodes will be inserted into the brain of patients with epilepsy while they are undergoing a clinically indicated assessment with intracranial electroencephalography (EEG). The micro-electrode array is able to continuously record the activity of neurons in the human brain. In combination with the standard intracranial EEG, the recordings of the micro-electrode array will allow a better understanding of the relationship between epileptic seizures and the activity of neurons.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Hôpitaux Universitaires de Genève

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient 18 years old or older
• Patient who suffers from potentially surgically remediable drug-resistant focal epilepsy
• Patient in whom neocortical resective surgery is deemed likely
• Patient who requires evaluation with intracranial subdural EEG electrodes
• Patient in whom a cortical area that is not eloquent (i.e. not involved in a critical neurological function like language or motor control) is deemed highly likely to be involved in seizure onset or propagation and is therefore an appropriate site for the implantation of the micro-electrode array
• Patient who is able and willing to provide informed consent

Exclusion Criteria:

• Patient in whom neocortical resective surgery is deemed unlikely (e.g. patients in whom a corpus callosotomy or another palliative epilepsy surgery procedure is planned)
• Patient who will be investigated with stereo-EEG electrodes only (these patients will not undergo a craniotomy for clinical purposes, and implantation of the micro-electrode array is therefore impossible)
• Patient whose epileptic seizures cause hypermotor or violent motor behavior (due to the risk of MD mechanical failure and related injury)
• Patient with a previous history of bacterial meningitis (due to the risk of thickening of the arachnoid membrane complicating the implantation of the micro-electrode array)
• Patient with severe psychiatric disease or psychological distress
• Patient with severe concomitant medical disease (including, but not limited to, cardiovascular disease, respiratory illness, renal failure, hepatic dysfunction, etc.)
• Patient with known compromise of the immune system caused by a medical condition or the chronic consumption of immunosuppressant medication (due to the increased risk of infection; this includes diabetes mellitus)
• Patient with colonization with methicillin-resistant Staphylococcus aureus (due to the increased risk of difficult-to-manage infection)
• Patient with known tendency for increased bleeding (due to the increased risk of hemorrhage)
• Patient with an implanted intracranial stimulator, vagus nerve stimulator, or cochlear implant that will remain active during the study (due to the potential for interference with the micro-electrode recordings)
• Women who are pregnant or breastfeeding during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Implantation of the Blackrock NeuroPort micro-electrode array for up to 29 days in patients who are undergoing evaluation with intracranial EEG electrodes	Device: NeuroPort micro-electrode array; Implantation of the Blackrock NeuroPort micro-electrode array for up to 29 days in patients who are undergoing evaluation with intracranial EEG electrodes; Other Names: Blackrock Microsystems

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with study procedure- and investigational device-related serious adverse events, as defined in ISO 14155	Number of patients experiencing any serious adverse event, as defined in ISO 14155 (any untoward medical occurrence that resulted in death or led to a serious deterioration in health), that is possibly, probably or definitely related to study procedures or the investigational device. Participants will be hospitalized throughout the duration of their participation in the study. Serious adverse events will be monitored daily by a physician through history taking, neurological examination, measurements of vital signs as well as every other day with blood testing for markers of inflammation (leucocytosis and elevated C-reactive protein).	On average 4 weeks
Correlation between EEG markers of epileptic activity and single-neuron activity recorded by the investigational device	The characteristics of single-neuron activity (recorded by the investigational device) will be studied during epileptic events as identified by the clinical intracranial EEG (interictal epileptic discharges, high-frequency oscillations, epileptic seizures), including (not necessarily limited to) average firing rate, across-neuron firing synchronization, phase-amplitude coupling with slow cortical oscillations. These analyses will be performed using specialized, custom-programmed neural time series data processing software.	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of single neurons recorded from investigational device	Number of single neurons isolated by the investigational device and stability over time of these recordings. These analyses will be performed using specialized, custom-programmed neural time series data processing software.	Up to 4 weeks

Collaborators and Investigators

• Sponsor: Wyss Center for Bio and Neuroengineering
• Investigators: Principal Investigator: Margitta Seeck, MD, Hôpitaux Universitaires de Genève

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2017
• Primary Completion (Actual): December 20, 2019
• Study Completion (Actual): December 20, 2019

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: October 11, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 31, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Epilepsy surgery; Micro-electrode arrays; Single-neuron recordings; Electrocorticography
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: IN-MAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No