EpilepsyeCORTANCT05551403
Cortical Excitability and Treatment Response in People with Epilepsy
A study testing Eyes-closed rest-EEG registration, Transcranial Magnetic Stimulation during EEG and EMG registrations and Photic stimulation during eyes-closes EEG registration in people with Epilepsy, run by Stichting Epilepsie Instellingen Nederland at 2 sites in Netherlands.
Trial summary
Epilepsy is a medical condition marked by the occurrence of unpredictable, recurrent seizures. One-third of people with epilepsy continue to experience seizures, despite having attempted multiple forms of anti-seizure medication (ASM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Eyes-closed rest-EEG registration, Transcranial Magnetic Stimulation during EEG and EMG registrations and Photic stimulation during eyes-closes EEG registration
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesNetherlands
- Study dates
- 16 Mar 2022to 14 Feb 2025
- 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
- In agreement with their own neurologist to initiate adjuvant treatment with cenobamate
- Diagnosed with refractory focal epilepsy, which means two ASMs failed to cause seizure freedom.
- Age of 18 years or older
- Having kept a seizure diary for the past 12 weeks
- At least one seizure in the past 12 weeks.
Who cannot join
- Photosensitive epilepsy
- Any device or structure in the skull or in close proximity of the head area containing metal, including cochlear implants, implanted neurostimulators, cardiac pacemakers and intracardiac lines.
- Persistent skull opening following trauma or surgery
- Evidence (clinical or radiological) of major structural abnormality of the motor cortex or pyramidal tracts
- Any major psychiatric condition such as a psychotic disorder
- Pregnancy
- Learning disabilities preventing the comprehension of oral and/or written instructions
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Stichting Epilepsie Instellingen Nederland (SEIN)
Heemstede, North Holland, 2103 SW
Erasmus Medical Center
Rotterdam, South Holland, 3015 CN
About this study
Official title: Electrophysiological Markers of Cortical Excitability to Predict Response to Treatment with Anti-seizure Medication - the ECORTA Study
Epilepsy is a medical condition marked by the occurrence of unpredictable, recurrent seizures. One-third of people with epilepsy continue to experience seizures, despite having attempted multiple forms of anti-seizure medication (ASM). Currently, response to ASM is assessed on a trial-and-error basis as their efficacy can only be determined in hindsight. This causes delays in finding the proper treatment per individual. Responsiveness of the outer brain layer to external stimuli, termed cortical excitability (CE), may be used as additional means of treatment evaluation.
In this study, the investigators aim to measure CE before and after starting with ASM, so as to determine whether indicators of CE can be used to predict favorable response to the medication. Participants in this study are adult individuals with uncontrolled seizures that will start with the novel anti-seizure medicine cenobamate. The investigators hypothesize that, after starting with ASM, the CE will decrease in people with epilepsy who show a favorable response to the medication. Conversely, the investigators anticipate that the CE will not decrease in those that do not react to the mediation.
The investigators will address this hypothesis by evaluating both brain activity (electroencephalography, EEG) during rest and during different types of stimulation (magnetic, light flashes). Besides, the investigators will measure the subjective experiences of participants by using questionnaires on the quality of life and feelings of anxiety or depression. These measurements are performed at a baseline instance, just before starting with ASM, and at two instances after start with the ASM. Participants in the study will track the occurrence of seizures - using a diary - from 12 weeks before ASM start up till 12 months after ASM start. The investigators will compare seizure frequency with both changes in brain activity and subjective experiences by the participants.
- Conditions
- Epilepsy
- Being tested
- Eyes-closed rest-EEG registration, Transcranial Magnetic Stimulation during EEG and EMG registrations, Photic stimulation during eyes-closes EEG registration
- Keywords
- Epilepsy, Transcranial Magnetic Stimulation, Evoked Potentials, Visual, Electroencephalography, Anticonvulsants, Seizures
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyes-closed rest-EEG registrationDevice
Recording of spontaneous brain activity while eyes are shut for the duration of 7 minutes using a tablet with instructions
Transcranial Magnetic Stimulation during EEG and EMG registrationsDevice
Recording of TMS-evoked EEG and EMG responses according to various stimulation protocols
Photic stimulation during eyes-closes EEG registrationDevice
Recording of visual evoked potentials in the EEG during flash stimulation by light-emitting diode (LED) goggles (while eyes are closed)
| Study group | Role | What they receive |
|---|---|---|
| rest-EEG, TMS-EEG/TMS-electromyography(EMG) and photic stimulation | Experimental | Not described Receives: Device: Eyes-closed rest-EEG registration; Device: Transcranial Magnetic Stimulation during EEG and EMG registrations; Device: Photic stimulation during eyes-closes EEG registration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Influence of cenobamate initiation on the resting motor threshold (rMT) when comparing short-term responders and non-responders
Pre- to post-cenobamate initiation change in cortical excitability assessed using the rMT in responders vs. non-responders. Classification into the latter is determined by comparing the seizure frequency in the 3 months post-target dose interval to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Measured: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on transcranial magnetic stimulation (TMS)-evoked EEG potentials (TEP) when comparing short-term responders and non-responders
Pre- to post-cenobamate initiation change in cortical excitability assessed using TEP amplitudes in responders vs. non-responders. Classification into the latter is determined by comparing the seizure frequency in the 3 months post-target dose interval to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Measured: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Secondary outcomes (10)
Influence of cenobamate initiation on phase clustering and the neural network excitability index (NNEI) between visual evoked potential (VEP) trials when comparing short-term responders and non-responders
Pre- to post-cenobamate initiation change in cortical excitability assessed using VEP parameters (i.e. phase clustering and directly-related NNEI) in responders vs. non-responders. Classification into the latter is determined by comparing the seizure frequency in the 3 months post-target dose to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Measured: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on the mean functional connectivity (MFC) and phase-amplitude coupling (PAC) in resting-state (rs-)EEG data when comparing short-term responders and non-responders
Pre- to post-cenobamate initiation change in cortical excitability using rs-EEG parameters (i.e. MFC and PAC values in the 0-120 Hz EEG frequency range) in responders vs. non-responders. Classification into the latter is determined by comparing the seizure frequency in the 3 months post-target dose interval to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Measured: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on transcranial magnetic stimulation (TMS)-EMG and EEG, intermittent photic stimulation (IPS)-EEG and resting state (rs-)EEG parameters when comparing long-term responders and non-responders
TMS-EMG/-EEG parameters, IPS-EEG parameters, and rs-EEG parameters at T0, T1 and T2, incorporated as factors in a single multivariate statistical model alongside a factor for cenobamate response; i.e. responder or non-responder. Classification into the latter is determined by comparing the seizure frequency in the 12 months post-cenobamate initiation to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Measured: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2).
Correlation between the pre- to post-cenobamate initiation change in the resting motor threshold (rMT) and change in the seizure frequency when comparing short-term responders and non-responders to cenobamate
Classification of subjects into responders and non-responders to cenobamate is determined by comparing the seizure frequency in the 3 months post-target dose interval to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Measured: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on transcranial magnetic stimulation-induced EEG oscillations (TIO) when comparing short-term responders and non-responders
Pre- to post-cenobamate initiation change in cortical excitability assessed using TIO in responders vs. non-responders. Classification into the latter is determined by comparing the seizure frequency in the 3 months post-target dose interval to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Measured: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on phase clustering between TEP trials when comparing short-term responders and non-responders
Pre- to post-cenobamate initiation change in cortical excitability assessed using phase clustering between TEP trials in responders vs. non-responders. Classification into the latter is determined by comparing the seizure frequency in the 3 months post-target dose interval to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Measured: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on the neural network excitability index (NNEI) between TEP trials when comparing short-term responders and non-responders
Pre- to post-cenobamate initiation change in cortical excitability assessed using the NNEI between TMS-evoked EEG potential trials in responders vs. non-responders. Classification into the latter is determined by comparing the seizure frequency in the 3 months post-target dose to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Measured: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on the short-interval intracortical inhibition (SICI) when comparing short-term responders and non-responders
Pre- to post-cenobamate initiation change in cortical excitability assessed using SICI of motor evoked potential amplitudes in responders vs. non-responders. Classification into the latter is determined by comparing the seizure frequency in the 3 months post-target dose interval to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Measured: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on the long-interval intracortical inhibition (LICI) when comparing short-term responders and non-responders
Pre- to post-cenobamate initiation change in cortical excitability assessed using LICI of motor evoked potential amplitudes in responders vs. non-responders. Classification into the latter is determined by comparing the seizure frequency in the 3 months post-target dose interval to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Measured: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on the cortical silent period (CSP) when comparing short-term responders and non-responders
Pre- to post-cenobamate initiation change in cortical excitability assessed using the CSP after motor evoked potentials in responders vs. non-responders. Classification into the latter is determined by comparing the seizure frequency in the 3 months post-target dose interval to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Measured: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start16 Mar 2022
- Primary completion29 Feb 2024
- Study completion14 Feb 2025
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stichting Epilepsie Instellingen Nederland
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05551403
- Sponsor's protocol ID
- NL77887.058.21
- Other IDs
- P21.092
- Acronym
- eCORTA
- Status last verified
- Apr 2024
- First submitted
- 22 Jun 2022
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electrophysiological Markers of Cortical Excitability to Predict Response to Treatment with Anti-seizure Medication - the ECORTA Study
- ClinicalTrials.gov ID
- NCT05551403
- Acronym / sponsor ID
- eCORTA / NL77887.058.21
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Transcranial Magnetic Stimulation, Evoked Potentials, Visual, Electroencephalography, Anticonvulsants, Seizures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Stichting Epilepsie Instellingen NederlandUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 22 Sep 2022 (actual)
- 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.
Epilepsy is a medical condition marked by the occurrence of unpredictable, recurrent seizures. One-third of people with epilepsy continue to experience seizures, despite having attempted multiple forms of anti-seizure medication (ASM). Currently, response to ASM is assessed on a trial-and-error basis as their efficacy can only be determined in hindsight. This causes delays in finding the proper treatment per individual. Responsiveness of the outer brain layer to external stimuli, termed cortical excitability (CE), may be used as additional means of treatment evaluation.
In this study, the investigators aim to measure CE before and after starting with ASM, so as to determine whether indicators of CE can be used to predict favorable response to the medication. Participants in this study are adult individuals with uncontrolled seizures that will start with the novel anti-seizure medicine cenobamate. The investigators hypothesize that, after starting with ASM, the CE will decrease in people with epilepsy who show a favorable response to the medication. Conversely, the investigators anticipate that the CE will not decrease in those that do not react to the mediation.
The investigators will address this hypothesis by evaluating both brain activity (electroencephalography, EEG) during rest and during different types of stimulation (magnetic, light flashes). Besides, the investigators will measure the subjective experiences of participants by using questionnaires on the quality of life and feelings of anxiety or depression. These measurements are performed at a baseline instance, just before starting with ASM, and at two instances after start with the ASM. Participants in the study will track the occurrence of seizures - using a diary - from 12 weeks before ASM start up till 12 months after ASM start. The investigators will compare seizure frequency with both changes in brain activity and subjective experiences by the participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rest-EEG, TMS-EEG/TMS-electromyography(EMG) and photic stimulation | Experimental | Device: Eyes-closed rest-EEG registration, Device: Transcranial Magnetic Stimulation during EEG and EMG registrations, Device: Photic stimulation during eyes-closes EEG registration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- In agreement with their own neurologist to initiate adjuvant treatment with cenobamate
- Diagnosed with refractory focal epilepsy, which means two ASMs failed to cause seizure freedom.
- Age of 18 years or older
- Having kept a seizure diary for the past 12 weeks
- At least one seizure in the past 12 weeks.
Key exclusion criteria (7 listed)
- Photosensitive epilepsy
- Any device or structure in the skull or in close proximity of the head area containing metal, including cochlear implants, implanted neurostimulators, cardiac pacemakers and intracardiac lines.
- Persistent skull opening following trauma or surgery
- Evidence (clinical or radiological) of major structural abnormality of the motor cortex or pyramidal tracts
- Any major psychiatric condition such as a psychotic disorder
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 |
|---|---|---|
| Eyes-closed rest-EEG registrationRecording of spontaneous brain activity while eyes are shut for the duration of 7 minutes using a tablet with instructions | Device | rest-EEG, TMS-EEG/TMS-electromyography(EMG) and photic stimulation |
| Transcranial Magnetic Stimulation during EEG and EMG registrationsRecording of TMS-evoked EEG and EMG responses according to various stimulation protocols | Device | rest-EEG, TMS-EEG/TMS-electromyography(EMG) and photic stimulation |
| Photic stimulation during eyes-closes EEG registrationRecording of visual evoked potentials in the EEG during flash stimulation by light-emitting diode (LED) goggles (while eyes are closed) | Device | rest-EEG, TMS-EEG/TMS-electromyography(EMG) and photic stimulation |
Primary outcome
Influence of cenobamate initiation on the resting motor threshold (rMT) when comparing short-term responders and non-responders
Time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Pre- to post-cenobamate initiation change in cortical excitability assessed using the rMT in responders vs. non-responders. Classification into the latter is determined by comparing the seizure frequency in the 3 months post-target dose interval to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
Influence of cenobamate initiation on transcranial magnetic stimulation (TMS)-evoked EEG potentials (TEP) when comparing short-term responders and non-responders
Time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Pre- to post-cenobamate initiation change in cortical excitability assessed using TEP amplitudes in responders vs. non-responders. Classification into the latter is determined by comparing the seizure frequency in the 3 months post-target dose interval to the seizure frequency in the 3 months baseline interval (responder determined by a significant seizure reduction according to Poisson distribution statistics).
10 secondary outcomes
Influence of cenobamate initiation on phase clustering and the neural network excitability index (NNEI) between visual evoked potential (VEP) trials when comparing short-term responders and non-responders
Time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on the mean functional connectivity (MFC) and phase-amplitude coupling (PAC) in resting-state (rs-)EEG data when comparing short-term responders and non-responders
Time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on transcranial magnetic stimulation (TMS)-EMG and EEG, intermittent photic stimulation (IPS)-EEG and resting state (rs-)EEG parameters when comparing long-term responders and non-responders
Time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2).
Correlation between the pre- to post-cenobamate initiation change in the resting motor threshold (rMT) and change in the seizure frequency when comparing short-term responders and non-responders to cenobamate
Time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on transcranial magnetic stimulation-induced EEG oscillations (TIO) when comparing short-term responders and non-responders
Time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on phase clustering between TEP trials when comparing short-term responders and non-responders
Time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on the neural network excitability index (NNEI) between TEP trials when comparing short-term responders and non-responders
Time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on the short-interval intracortical inhibition (SICI) when comparing short-term responders and non-responders
Time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on the long-interval intracortical inhibition (LICI) when comparing short-term responders and non-responders
Time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
Influence of cenobamate initiation on the cortical silent period (CSP) when comparing short-term responders and non-responders
Time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)
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 20 Feb 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eyes-closed rest-EEG registration, Transcranial Magnetic Stimulation during EEG and EMG registrations and Photic stimulation during eyes-closes EEG registration in people with Epilepsy, run by Stichting Epilepsie Instellingen Nederland at 2 sites in Netherlands.
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 5 inclusion and 7 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 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
Influence of cenobamate initiation on the resting motor threshold (rMT) when comparing short-term responders and non-responders (time frame: At cenobamate initiation (T0), 7-8 weeks after cenobamate initiation (T1), and optionally at the maximum dose reached after individual treatment durations up to 1 year after cenobamate initiation (T2)). 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 20 Feb 2025.