(1) To determine frequency of antibody-mediated encephalopathy in adults with new-onset epilepsy/status epilepticus or chronic epilepsy. (2) To assess outcome of antibody-mediated encephalopathy in adults with epilepsy, and identify markers for good…
ID
Source
Brief title
Condition
- Autoimmune disorders
- Central nervous system infections and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. characterise new antibody mediated clinical syndromes causing epilepsy.
2. Measure the frequency of every individual antibody mediated syndrome causing
epilepsy in adults.
3. Look at outcome of individual antibody mediated syndrome causing epilepsy in
adults.
Secondary outcome
- What clinical and epidemiological markers are linked to the specific,
individual antibodies?
- What markers define poor or good prognosis in adults?
Background summary
Recently new treatable causes of epilepsy have been identified. These disorders
are caused by a disruption of the balance in the brain caused by
inflammation.This inflammative reaction is caused by an autogene reaction of
the immune system to specific brain proteins. The body produces antibodies to
specific parts of the brain. These disorders can lead to epilepsy, memory and
psychiatric problems. Recognition is necessary for good treatment. Mostly
anti-epileptic drugs are not sufficient. The disease can be treated with
immmunemodulating therapy. The ACES Study will focus on finding new, not ready
known antibodies, causing epilesy. Therefore we will regard patients with
epilepsy of unknown origin. To find new antibodies we need to add sera of
patients with epilepsy to cultivated cells to look for a reaction. If we detect
new antibodies we will map clinical features of the patientes. Also we will
determine the effects of antibodies on brain cells. Finding of new antibodies
can provide new treatment options for these patients. Also this will able us to
find out more about the etiology of epilepsy.
Study objective
(1) To determine frequency of antibody-mediated encephalopathy in adults with
new-onset epilepsy/status epilepticus or chronic epilepsy.
(2) To assess outcome of antibody-mediated encephalopathy in adults with
epilepsy, and identify markers for good or poor prognosis.
(3) To identify the target auto-antigens of selected epilepsy syndromes in
adults for which we have preliminary evidence of antibodies to neuronal cell
surface/synaptic proteins.
(4) To assess the effects of the antibodies on neurons and/or synapses in vitro
and, for the most interesting 1 or 2 antibodies/antigens, in vivo.
Study design
Prospective Observational Cohort Study.
Study burden and risks
The study patients will have one venapunction, with negligible risks and burden.
Patients from cohort 1 (status epilepticus and new onset epilepsy wuth
suspicion of encephalitis) frequently have a decreased consiousness, as
manifestation of the disease. The study is only applicable in clinically
affected patients and can thus only be carried out in this group of incompetent
patients. For patients in cohort 2 (chronic epilepsy patients) this will not be
an issue.
's Gravendijkwal 230 's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230 's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
- Age of 18 and older.
- Status epilepticus or new onset seizures with signs of limbic encephalitis (clinical picture, MRI (FLAIR abnormalities), EEG abnormalities or CSF findings (CSF pleocytosis, increased IgG index, oligoclonal bands)
- Patients with acquired chronic focal epilepsy with an unknown cause.
- A subgroup of these patients, with chronic focal epilepsy, undergoing epilepsy surgery (without a known underlying cause of their epilepsy or possible (post) encephalitis changes, like mesiotemporal sclerosis and hippocampal sclerosis). These are patients with a pharmacoresistent epilepsy, not responding to first and second-line anti-epileptic drugs.
Exclusion criteria
Patients < 18 years.
Epilepsy with known cause.
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 |
|---|---|
| ClinicalTrials.gov | NCT02802475 |
| CCMO | NL50096.078.14 |