The primary aim of this clinical trial and healthcare evaluation (in Dutch: Zorgevaluatie) is to compare the diagnostic value of two diagnostic EEG strategies (repeated EEG with and without prior sleep deprivation) frequently applied in current…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are repeated EEG diagnostic sensitivity (percentage of
patients with epileptiform abnormalities on repeated EEG out of all patients
with a certain epilepsy diagnosis after 2-year follow-up) and EEG-specific
patient burden.
Secondary outcome
Secondary endpoints include overall diagnostic accuracy, sleep
deprivation-associated seizure risk (measured by comparing the frequencies of
recurrent seizures within 24 hours after the EEG of the two EEG strategies),
cumulative incidence of seizure recurrence, patient burden in terms of quality
of life and indicators for depression/anxiety, physician working diagnosis and
probability estimate of epilepsy likelihood.
Background summary
Epilepsy is diagnosed if two or more unprovoked seizures have occurred at least
24 hours apart or in case of a high seizure recurrence risk determined by
diagnostic tests such as electroencephalography (EEG) recordings. A single
routine baseline EEG (bEEG) has limited diagnostic accuracy (sensitivity 44%
and specificity 79%). In case of a bEEG without epileptiform activity, the
current guideline recommends a repeated EEG after sleep deprivation (sdEEG).
This is burdensome to patients and caregivers and evidence supporting the
benefit of sdEEG over other diagnostic EEG strategies such as repeating the
routine EEG (rEEG) is weak. This has led to low guideline adherence, widespread
practice variation, and significant patient inequality regarding 1) epilepsy
diagnoses, 2) treatment and risk of seizure recurrence, 3) fitness to drive, 4)
diagnostic costs, 5) patient burden and stigma, 6) health damage due to
recurrent seizures.
Study objective
The primary aim of this clinical trial and healthcare evaluation (in Dutch:
Zorgevaluatie) is to compare the diagnostic value of two diagnostic EEG
strategies (repeated EEG with and without prior sleep deprivation) frequently
applied in current clinical practice. Specifically, this trial will determine
whether sdEEG has higher diagnostic accuracy (in particular sensitivity) and
EEG-associated patient burdencompared to a repeated rEEG for first seizure
patients with a bEEG without epileptiform activity.
Study design
National multicentre prospective diagnostic randomised controlled trial and
healthcare evaluation.
Study burden and risks
We will include patients aged 12 to 18 years old since the findings of this
trial will be group-related. The underlying causes for epilepsy and therefore
the yield of diagnostic strategies are not comparable between young people and
older adults. The additional risks of participation are negligible since all
participants will receive usual care: both EEG strategies are currently
frequently used in clinical practice. Participants will fill out three
questionnaires (~30 minutes) and will have four -or five in case of a recurrent
seizure/epilepsy- follow-up appointments over the phone with their treating
physician. For this healthcare evaluation, children below the age of 12 will
not be included since young children often suffer from specific childhood
epilepsy syndromes. The diagnostic process for young children therefore
requires a different approach which means that the current healthcare
evaluation is not suitable for this group of patients.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
We will include patients >=12 years old with a first unprovoked seizure with a
non-epileptiform baseline EEG.
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
• The patient was at least 12 years old at the time of the seizure.
• The treating physician should consider that the patient had an epileptic
seizure (not just a syncope).
• Epilepsy is considered as a potential diagnosis by the treating physician
(the repeated EEG should be requested due to an ongoing suspicion of epilepsy
although the bEEG showed no epileptiform abnormalities, not just to reassure
the patient).
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- The seizure was most likely acute symptomatic or provoked by drugs, alcohol
withdrawal, or extensive sleep deprivation (at least 24-hours awake).
- Initial presentation with status epilepticus.
- Explanatory structural abnormality on imaging prior to inclusion, based on
which epilepsy diagnosis can be established.
- Explanatory syndrome or genetic mutation based on which epilepsy diagnosis
can be established.
- Prior epilepsy diagnosis.
- Known or suspected neurodegenerative disease.*
- Moderate to profound intellectual disability (IQ <50).*
- Daily use of antiseizure medication for any reason (e.g.
migraines/psychiatric indication/chronic pain). NB: this includes daily use of
benzodiazepines.
- Not able or willing to provide (written) informed consent.
- Not able or willing to answer questionnaires in Dutch or English.
Design
Recruitment
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 | NL87182.041.24 |