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

NCT02932839 | Completed DMC

• 1 other identifier: IN-MAP
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Epilepsy surgery; Micro-electrode arrays; Single-neuron recordings; Electrocorticography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Number of single neurons recorded from investigational device

  Up to 4 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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

Interventions

NeuroPort micro-electrode array DEVICE

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

Also known as: Blackrock Microsystems

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wyss Center for Bio and Neuroengineering: lead

Study Sites (1)

Hôpitaux Universitaires de Genève

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Margitta Seeck, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: October 13, 2016
• Study Start: December 28, 2017
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: June 2, 2021

Record last verified: 2021-03

Locations

CH (1)