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

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
NeuroPort micro-electrode array
Sponsored by
Wyss Center for Bio and Neuroengineering
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Epilepsy focused on measuring Epilepsy surgery, Micro-electrode arrays, Single-neuron recordings, Electrocorticography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpitaux Universitaires de Genève

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Implantation of the Blackrock NeuroPort micro-electrode array for up to 29 days in patients who are undergoing evaluation with intracranial EEG electrodes

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 26, 2016
Last Updated
May 31, 2021
Sponsor
Wyss Center for Bio and Neuroengineering
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1. Study Identification

Unique Protocol Identification Number
NCT02932839
Brief Title
Investigating the Neuronal Bases of Epilepsy With Micro-electrode Arrays in Candidates for Epilepsy Surgery
Acronym
IN-MAP
Official Title
Investigating the Neuronal Bases of Epilepsy With Micro-electrode Arrays in Patients Who Are Candidates for Epilepsy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 28, 2017 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wyss Center for Bio and Neuroengineering

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy surgery, Micro-electrode arrays, Single-neuron recordings, Electrocorticography

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Implantation of the Blackrock NeuroPort micro-electrode array for up to 29 days in patients who are undergoing evaluation with intracranial EEG electrodes
Intervention Type
Device
Intervention Name(s)
NeuroPort micro-electrode array
Other Intervention Name(s)
Blackrock Microsystems
Intervention Description
Implantation of the Blackrock NeuroPort micro-electrode array for up to 29 days in patients who are undergoing evaluation with intracranial EEG electrodes
Primary Outcome Measure Information:
Title
Number of participants with study procedure- and investigational device-related serious adverse events, as defined in ISO 14155
Description
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).
Time Frame
On average 4 weeks
Title
Correlation between EEG markers of epileptic activity and single-neuron activity recorded by the investigational device
Description
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.
Time Frame
Up to 4 weeks
Secondary Outcome Measure Information:
Title
Number of single neurons recorded from investigational device
Description
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.
Time Frame
Up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margitta Seeck, MD
Organizational Affiliation
Hôpitaux universitaires de Genève
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpitaux Universitaires de Genève
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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