To address the potential of cortical excitability measures using TMS-EEG/EMG to differentiate between responders and non-responders to ASM in people with refractory focal epilepsy. The secondary objectives are to validate visual evoked potentials (…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Change in cortical excitability parameters using TMS-EEG/EMG concerning
treatment response.
Secondary outcome
- Change in cortical excitability parameters using VEP-EEG, task and resting
state EEG in relation to treatment response
- Utility of excitability parameters at T1 and optional T2 to predict treatment
response on the long term by comparing measures between T0, T1 and optional T2
to seizure reduction after 12 months
- Change in rMT between T0 and T1 correlated to change in seizure
frequency in percentage
- Change in scores calculated from the used questionnaires to determine
anxiety, seizure severity and QOL
Background summary
Epilepsy is a paroxysmal and unpredictable condition; one-third of people
continue to have seizures despite anti-seizure medication (ASM). Treatment
appropriateness is decided on a trial and error basis as efficacy can only be
determined retrospectively, causing delays in finding the proper treatment.
Cortical excitability may provide a biomarker for treatment evaluation. The
study aims to measure cortical excitability changes after the initiation of an
ASM using transcranial magnetic stimulation (TMS) during EEG and EMG
registration (TMS-EEG/EMG), and to validate other EEG biomarkers to measure and
predict treatment response. We hypothesize the cortical excitability will
decrease after initiation of cenobamate in responders.
Study objective
To address the potential of cortical excitability measures using TMS-EEG/EMG to
differentiate between responders and non-responders to ASM in people with
refractory focal epilepsy. The secondary objectives are to validate visual
evoked potentials (VEP)-EEG, resting-state EEG and task-EEG in separating
responders and non-responders, the potential of the biomarkers as a predictor
of treatment success, and evaluate the influence of cenobamate on quality of
life (QOL) and anxiety.
Study design
This is a multicentre prospective study. Participants will undergo TMS-EEG/EMG,
VEP-EEG, resting-state EEG and task-EEG at baseline (T0), at 100 mg (T1) and
optional at a maximum dose (T2). They will keep a seizure diary for twelve
months and fill in questionnaires about QOL, anxiety and seizure severity at
baseline, at T1, optional T2 and after twelve months.
Study burden and risks
The participants have two or three visits when measurements (TMS-EEG/EMG,
VEP-EEG, resting-state EEG and task-EEG) will be performed. Also they will fill
in questionnaires about QOL, anxiety and seizure severity at two or three given
moments. The largest risk consists of a TMS-induced seizure. This poses a minor
risk.
Achterweg 5
Heemstede 2103SW
NL
Achterweg 5
Heemstede 2103SW
NL
Listed location countries
Age
Inclusion criteria
In agreement with their own neurologist to initiate adjuvant treatment with
cenobamate, diagnosed with focal epilepsy, 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, Cochlear implants, implanted neurostimulator or metal
in the brain or skull, persistent skull opening following trauma or surgery,
cardiac pacemaker, intracardiac lines, evidence (clinical or radiological) of
major structural abnormality of the motor cortex or pyramidal tracts, any major
psychiatric or neurological (other than epilepsy) condition, pregnancy,
learning disabilities.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL77887.058.21 |