Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06388161
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-04-16
Brief Title:
Neural Autoantibody Prevalence in New-onset Focal Seizures of Unknown Etiology
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Neural Autoantibody Prevalence in Patients With New-onset Focal Seizures of Unknown Etiology and a Predictive Scoring Scale
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Seizure is one of the most common symptoms in autoimmune encephalitis with neuronal surface-mediated antibodies Interestingly some patients may exhibit new-onset seizures as the initial manifestation without fulminant sign of encephalitis particularly in the early stage
It is essential to recognize these patients early and to perform antibody testing as studies have reported early immunotherapy can improve their clinical outcomes At the same time it is important to limit the number of patients who require testing for the sake of specificity and cost effectiveness Thus this prospective multicenter study aims to identify neural antibodies in patients with focal seizures of unknown etiology and to create a score to preselect patients requiring autoantibody testing
It is essential to recognize these patients early and to perform antibody testing as studies have reported early immunotherapy can improve their clinical outcomes At the same time it is important to limit the number of patients who require testing for the sake of specificity and cost effectiveness Thus this prospective multicenter study aims to identify neural antibodies in patients with focal seizures of unknown etiology and to create a score to preselect patients requiring autoantibody testing
Detailed Description:
1 Focal epileptic seizure or epilepsy is defined according to seizure semiology electroencephalography findings andor other relevant information If applicable 24 hour video-electroencephalography is performed
2 Clinical information is documented by specially-assigned persons including patient demographics age at onset disease duration seizure semiology seizure frequency clinical manifestations underlying malignancy hyponatremia brain MRI medications and other diseases
3 The Mini-Mental State Examination MMSE Montreal Cognitive Assessment MoCA Hamilton Depression Scale HAMA Hamilton Anxiety Scale HAMA and the modified Rankin Scale mRS at baseline were assessed and recorded
4 Previous scoring scales such as antibody prevalence in epilepsy and encephalopathy APE2 score antibodies contributing to focal epilepsy signs symptoms ACES score and the Obvious Indications for Neural Antibody Testing in Epilepsy or Seizures ONES checklist are evaluated at baseline
5 Commercial cell-based assay CBA EUROIMMUN Lübeck Germany was used to detect serum anti-N-methyl-D-aspartate receptor anti-NMDAR anti-α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor anti-AMPAR anti-γ-aminobutyric acid B receptor anti-GABABR anti-leucine-rich glioma-inactivated 1 anti-LGI1 anti-contactin-associated protein-like 2 anti-CASPR2 and anti-glutamic acid decarboxylase 65 anti-GAD65 anti-metabotropic glutamate receptor 5 mGluR5 anti-dipeptidyl peptidase-like protein 6 DPPX anti-myelin oligodendrocyte glycoprotein MOG and anti-immunoglobulin-like cell adhesion molecule 5 IgLON5 antibodies If serum neural autoantibodies are detected cerebrospinal fluid should be tested
2 Clinical information is documented by specially-assigned persons including patient demographics age at onset disease duration seizure semiology seizure frequency clinical manifestations underlying malignancy hyponatremia brain MRI medications and other diseases
3 The Mini-Mental State Examination MMSE Montreal Cognitive Assessment MoCA Hamilton Depression Scale HAMA Hamilton Anxiety Scale HAMA and the modified Rankin Scale mRS at baseline were assessed and recorded
4 Previous scoring scales such as antibody prevalence in epilepsy and encephalopathy APE2 score antibodies contributing to focal epilepsy signs symptoms ACES score and the Obvious Indications for Neural Antibody Testing in Epilepsy or Seizures ONES checklist are evaluated at baseline
5 Commercial cell-based assay CBA EUROIMMUN Lübeck Germany was used to detect serum anti-N-methyl-D-aspartate receptor anti-NMDAR anti-α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor anti-AMPAR anti-γ-aminobutyric acid B receptor anti-GABABR anti-leucine-rich glioma-inactivated 1 anti-LGI1 anti-contactin-associated protein-like 2 anti-CASPR2 and anti-glutamic acid decarboxylase 65 anti-GAD65 anti-metabotropic glutamate receptor 5 mGluR5 anti-dipeptidyl peptidase-like protein 6 DPPX anti-myelin oligodendrocyte glycoprotein MOG and anti-immunoglobulin-like cell adhesion molecule 5 IgLON5 antibodies If serum neural autoantibodies are detected cerebrospinal fluid should be tested
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None