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Clinical Trials/CTRI/2021/12/038528
CTRI/2021/12/038528Not yet recruiting未知

Design and evaluation of an EEG based deep learning system for epilepsy diagnosis: An ICMR approved extramural ad-hoc research project

Indian Council of Medical Research0 sites0 target enrollmentStarted: TBDLast updated:
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Trial Snapshot

Phase
未知
Status
Not yet recruiting
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Observational

Eligibility Criteria

Inclusion Criteria

  • •1. Age >= 12 years and <= 60 years at the time of enrollment.
  • •2. Patients with epilepsy:
  • •a. Patients with confirmed diagnosis of epilepsy according to ILAE guidelines (whether
  • •on AEDs or not).
  • •b. If the patient is on AEDs at the time of EEG recording, at least one seizure should have
  • •occurred in the 180-day period preceding the EEG recording and there should have
  • •been no change in the AED regimen post the last seizure date.
  • •c. One of the following:
  • •(i) Normal MRI Brain / CT Brain
  • •(ii) A single focal lesion or gliosis in one region in MRI Brain / CT Brain with
  • •size <= 20mm (acceptable lesions include NCC, tuberculoma, MTS, FCD,
  • •single cavernoma, AVM, small tumor, small infarct, small intracranial
  • •haemorrhage).
  • •3. Patients with epilepsy mimickers: Patients with epilepsy mimickers having abnormal
  • •confirmed findings for etiology in corresponding diagnostic tests.
  • •4. Healthy subjects: No history of unconsciousness, neurological, psychiatric or
  • •developmental disorders.
  • •5. EEG of patient recorded on Natus Brain Monitor EEG Machine (in order to maintain
  • •uniformity in data acquisition).

Exclusion Criteria

  • •1. MRI Brain / CT Brain findings showing extensive damage to brain >= 20mm as they would
  • •likely alter biomarkers. This includes disorders like TBI, stroke, encephalitis,
  • •meningoencephalitis, multiple NCC, multiple tuberculomas.
  • •2. History of intracranial bleeding (e.g., subarachnoid, intraparenchymal).
  • •3. Patients with epilepsy mimickers not having confirmed etiology.
  • •4. Patients having dementia, Parkinsons disease and other neurodegenerative disorders, neurodevelopmental disorders, cerebral palsy, hypoxic ischemic encephalopathy.
  • •5. Patients with confounding psychiatric disorders like schizophrenia and bipolar mood
  • •6. Patients with a history of drug abuse or alcohol addiction.
  • •7. Patients having provoked seizures (E.g. seizure within 1 week of any brain insult such as
  • •head injury/stroke/brain infection, hyponatremia, hypocalcemia, hypomagnesemia,
  • •hyperammonemia, hypoglycemia, drug toxicity).
  • •8. Seizures only during pregnancy.
  • •9. Non-availability of a 5-minute eyes-closed awake resting state portion (see Quality
  • •Assurance Measures) or excessive artifacts in the EEG recording rendering it unusable for
  • •10. Patients not providing informed consent

Investigators

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