Cortical Excitability and Treatment Response in People with Epilepsy

NCT ID: NCT05551403

Last Updated: 2025-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-16
• Study Completion Date: 2025-02-14

Brief 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). 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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

rest-EEG, TMS-EEG/TMS-electromyography(EMG) and photic stimulation

Group Type: EXPERIMENTAL

Eyes-closed rest-EEG registration

Intervention Type: DEVICE

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 registrations

Intervention Type: DEVICE

Recording of TMS-evoked EEG and EMG responses according to various stimulation protocols

Photic stimulation during eyes-closes EEG registration

Intervention Type: DEVICE

Recording of visual evoked potentials in the EEG during flash stimulation by light-emitting diode (LED) goggles (while eyes are closed)

Interventions

Eyes-closed rest-EEG registration

Recording of spontaneous brain activity while eyes are shut for the duration of 7 minutes using a tablet with instructions

Intervention Type: DEVICE

Transcranial Magnetic Stimulation during EEG and EMG registrations

Recording of TMS-evoked EEG and EMG responses according to various stimulation protocols

Intervention Type: DEVICE

Photic stimulation during eyes-closes EEG registration

Recording of visual evoked potentials in the EEG during flash stimulation by light-emitting diode (LED) goggles (while eyes are closed)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Stichting Epilepsie Instellingen Nederland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stichting Epilepsie Instellingen Nederland (SEIN)

Heemstede, North Holland, Netherlands

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Countries

Netherlands

Other Identifiers

P21.092

Identifier Type: OTHER

Identifier Source: secondary_id

NL77887.058.21

Identifier Type: -

Identifier Source: org_study_id