Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients

NCT05068323 | Unknown

• 1 other identifier: Epilepsy and Cognition
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Epilepsy is a common health problem worldwide. In general population, studies in developed countries estimated the annual incidence of epilepsy to be\~50 per 100,000 and prevalence to be \~8.2 per 1,000. These figures are higher in developing countries in which prevalence of \>10 per 1,000 was reported. In Upper Egypt, Assiut Governorate, the prevalence rate was 12.9 per 1,000. In people with epilepsy there is an associated high rate of cognitive difficulties that compromise educational progress and achievement throughout life. Approximately 1-5% of the population exhibits epileptiform discharges on electroencephalography (EEG). Interictal epileptiform discharges (IEDs), meaning spikes, polyspikes, sharp waves, or spike and slow-wave complexes without observed clinical seizures, are commonly observed in patients with epilepsy. Epilepsy syndromes manifesting with IEDs are detrimental to cognitive function. Recently, two studies found that frequent IEDs can impair cognitive performance in children. and adult patients. Several studies indicated that IEDs in patients with epilepsy had a disruptive effect on information processing speed with even a low percentage of IEDs (1%).However, it is unclear whether IEDs are associated with disrupted academic performance in patients with idiopathic epilepsy, and the relationship between general cognitive ability and academic performance in those patients has not been clarified. Understanding how IEDs interfere with neurocognitive outcomes is important ,while the goal of medical and surgical treatments for epilepsy is to achieve seizure-freedom with minimal morbidity, the benefits of IED suppression are more controversial.

Conditions

Cognitive Impairment; Epilepsy

Outcome Measures

Primary Outcomes (1)

• Evaluate the effect of some High frequency epileptiform discharges measured by HZ on some cognitive domines using electroencephalogram

  2 months

Study Arms (2)

Epilepsy

OTHER

Newly diagnosed epileptic patients

Diagnostic Test: Digital electroencephalography (EEG) for an hour (16 channels)

Control

SHAM COMPARATOR

healthy subjects

Diagnostic Test: Digital electroencephalography (EEG) for an hour (16 channels)

Interventions

Digital electroencephalography (EEG) for an hour (16 channels) DIAGNOSTIC_TEST

Digital electroencephalography (EEG) for an hour (16 channels)

Control; Epilepsy

Eligibility Criteria

• Age: 10 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \- a) Patients \[with age ranges from 10 to 50 years\] of both sex. b) Patients with confirmed diagnosis of idiopathic localization-related or generalized epilepsy.
• c) Either before receiving anti-epileptic drugs or on regular treatment with antiepileptic drugs for less three months.

You may not qualify if:

• Patients with symptomatic or secondary epilepsies either due to general medical conditions or drug induced.
• Other neurological , psychiatric or metabolic disorders that affect cognition.
• Regular use of antiepileptic medications more than three months.
• utilization of regular medications other than AEDs that affect cognition.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Shady Mohamed Safwat Mohamed Tawfik Hassan

Asyut, Egypt

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Epilepsy

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Central Study Contacts

Shady Mohamed Safwat Mohamed T Hassan, MD

CONTACT

00201008763141; Shady.hassan@aun.edu.eg

Mohamed Abdelmegid

CONTACT

0882080150; mohamedmagee2030@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Neurology

Model Details: case control

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 5, 2021
• Study Start: September 30, 2021
• Primary Completion: May 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 5, 2021

Record last verified: 2021-10

Locations

EG (1)