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

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ClinicalTrials.gov Identifier: NCT02932839
Recruitment Status : Recruiting
First Posted : October 13, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Wyss Center for Bio and Neuroengineering

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.

Condition or disease Intervention/treatment Phase
Epilepsy Device: NeuroPort micro-electrode array Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigating the Neuronal Bases of Epilepsy With Micro-electrode Arrays in Patients Who Are Candidates for Epilepsy Surgery
Study Start Date : January 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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 Name: Blackrock Microsystems




Primary Outcome Measures :
  1. Number of participants with study procedure- and investigational device-related serious adverse events, as defined in ISO 14155 [ Time Frame: On average 4 weeks ]
    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).

  2. Correlation between EEG markers of epileptic activity and single-neuron activity recorded by the investigational device [ Time Frame: Up to 4 weeks ]
    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 :
  1. Number of single neurons recorded from investigational device [ Time Frame: Up to 4 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02932839


Contacts
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Contact: Margitta Seeck, MD +41 (0)22 372 84 76 Margitta.Seeck@hcuge.ch
Contact: Pierre Mégevand, MD, PhD +41 (0)79 553 51 33 Pierre.Megevand@hcuge.ch

Locations
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Switzerland
Hôpitaux Universitaires de Genève Recruiting
Geneva, Switzerland, 1211
Contact: Margitta Seeck, MD    +41 (0)22 372 84 76    Margitta.Seeck@hcuge.ch   
Contact: Pierre Mégevand, MD, PhD    +41 (0)79 553 51 33    Pierre.Megevand@hcuge.ch   
Principal Investigator: Margitta Seeck, MD         
Sponsors and Collaborators
Wyss Center for Bio and Neuroengineering
Investigators
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Principal Investigator: Margitta Seeck, MD Hôpitaux Universitaires de Genève

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Responsible Party: Wyss Center for Bio and Neuroengineering
ClinicalTrials.gov Identifier: NCT02932839     History of Changes
Other Study ID Numbers: IN-MAP
First Posted: October 13, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Wyss Center for Bio and Neuroengineering:
Epilepsy surgery
Micro-electrode arrays
Single-neuron recordings
Electrocorticography

Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases