Development and Validation of a Computational Model for Epilepsy Diagnosis

Not Applicable

• Conditions: Health Condition 1: G409- Epilepsy, unspecifiedHealth Condition 2: F99- Mental disorder, not otherwise specifiedHealth Condition 3: I669- Occlusion and stenosis of unspecified cerebral arteryHealth Condition 4: I95-I99- Other and unspecified disorders of the circulatory system

• Registration Number: CTRI/2021/12/038528
• Lead Sponsor: Indian Council of Medical Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 February 2022

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

disorder.

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

analysis.

10. Patients not providing informed consent

Study & Design

• Study Type: Observational
• Study Design: Not specified