The mean objective of this research project is the implementation in daily clinical practice of MEG as the examination of the first choice for the diagnosis of patients with suspicion of epilepsy. Furthermore, the current project links directly to…
ID
Source
Brief title
Condition
- Neurological disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter is the clinical diagnosis at the end of the
trajectory, after completion of the standard EEG and MEG recordings, which is
considered as gold standard. .
Secondary outcome
The secondary outcomes will be (1) the patient experiences regarding each
diagnostic procedure, (2) the relevant cost-factors taking into account the
disease and interventions under investigation (EEG, EEsd, MEG), and (3) the
societal costs due to the consumption of health care and other goods
Background summary
The success and effectiveness of the treatment of epilepsy is highly dependent
on the specific type of epilepsy. Currently, the diagnosis of epilepsy is a
lengthy and stressful process for the patient. Initially epilepsy is diagnosed
on basis of clinical symptoms during seizures. A standard EEG can confirm the
diagnosis. However, in over 50% of the cases routinely applied EEG recording
(routine EEG) does not lead to an accurate diagnosis of patients with epilepsy.
If a routine EEG is inconclusive a EEG after sleep deprivation (EEGsd) or
24-hour EEG recording (24h-EEG) recording is performed. It has been argued
based on a number of recent studies that MEG is more sensitive to epileptic
discharges and, therefore, may present a more efficient alternative.
Furthermore, MEG is argued to be less burdensome for the patient and more
cost-effective than EEG.
Study objective
The mean objective of this research project is the implementation in daily
clinical practice of MEG as the examination of the first choice for the
diagnosis of patients with suspicion of epilepsy. Furthermore, the current
project links directly to the objective of sustained implementation of
innovative technology, which is patient friendly and (cost-)effective.
Study design
In a comparative trial all patients who are referred for a routine EEG will be
offered an extra MEG recording. After the routine EEG, additional EEG (EEGsd or
24h-EEG) and MEG recordings, patients are requested to indicate their
experiences on a visual analogue scale (VAS) on three different topics (stress
level, patient friendliness and quality of life). Furthermore, to measure the
use of health care resources, including all activities related to epilepsy, we
gather data for each patient at baseline, at the moment of inclusion in the
study, at the end of the trajectory and one year follow-up, including all
health care resources used.
Study burden and risks
MEG is a non-invasive technique that enables recording of epileptiform
discharges over the whole head, without placement of electrodes, while the
patient is in a supine position during the recordings. The burden for the
patient is an additional examination which only can be performed at VU Medical
Center in Amsterdam. Furthermore, additionally compared to standard procedures
are the questionnaires regarding the experiences (VAS) that have to be
completed after each examination (EEG, EEGsd or 24h-EEG, MEG) and the
questionnaires regarding the cost-effectiveness that have to be completed at
the final consultation with a follow-up after 12, 24, 38 weeks.
Sterkselsewg 65
Heeze 5591VE
NL
Sterkselsewg 65
Heeze 5591VE
NL
Listed location countries
Age
Inclusion criteria
- suspicion of epilepsy
- 6 years or older
- able to co-operate
Exclusion criteria
- a pacemaker or intracranial metal
- younger than six year
- patients who cannot meet the mild physical or psychological criteria for prolonged MEG scanning
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 | NL43357.029.13 |