EpilepsyIN-MAPNCT02932839
Investigating the Neuronal Bases of Epilepsy With Micro-electrode Arrays in Candidates for Epilepsy Surgery
A study testing NeuroPort micro-electrode array in people with Epilepsy, run by Wyss Center for Bio and Neuroengineering at 1 site in Switzerland.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- NeuroPort micro-electrode array
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Dec 2017to 20 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- NeuroPort micro-electrode array
- Keywords
- Epilepsy surgery, Micro-electrode arrays, Single-neuron recordings, Electrocorticography
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroPort micro-electrode arrayDevice
Also called Blackrock Microsystems
Implantation of the Blackrock NeuroPort micro-electrode array for up to 29 days in patients who are undergoing evaluation with intracranial EEG electrodes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: NeuroPort micro-electrode array |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Up to 4 weeks
Secondary outcomes (1)
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.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start28 Dec 2017
- Primary completion20 Dec 2019
- Study completion20 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wyss Center for Bio and Neuroengineering
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margitta Seeck, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932839
- Sponsor's protocol ID
- IN-MAP
- Acronym
- IN-MAP
- Status last verified
- Mar 2021
- First submitted
- 26 Sep 2016
- Last updated
- 2 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Neuronal Bases of Epilepsy With Micro-electrode Arrays in Patients Who Are Candidates for Epilepsy Surgery
- ClinicalTrials.gov ID
- NCT02932839
- Acronym / sponsor ID
- IN-MAP / IN-MAP
- Conditions
- Epilepsy
- Keywords
- Epilepsy surgery, Micro-electrode arrays, Single-neuron recordings, Electrocorticography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Wyss Center for Bio and NeuroengineeringUniversity, hospital or other
- Study start
- 28 Dec 2017 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- 20 Dec 2019 (actual)
- First posted
- 13 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: NeuroPort micro-electrode arrayImplantation of the Blackrock NeuroPort micro-electrode array for up to 29 days in patients who are undergoing evaluation with intracranial EEG electrodes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroPort micro-electrode arrayAlso: Blackrock MicrosystemsImplantation of the Blackrock NeuroPort micro-electrode array for up to 29 days in patients who are undergoing evaluation with intracranial EEG electrodes | Device | Intervention |
Primary outcome
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).
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.
1 secondary outcome
Number of single neurons recorded from investigational device
Time frame: Up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Epilepsy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margitta Seeck, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroPort micro-electrode array in people with Epilepsy, run by Wyss Center for Bio and Neuroengineering at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with study procedure- and investigational device-related serious adverse events, as defined in ISO 14155 (time frame: On average 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2021.