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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Epilepsy; Cognitive Impairment
• Intervention / Treatment: Diagnostic test: Digital electroencephalography (EEG) for an hour (16 channels)

Detailed Description

This study aims to

1. Evaluate the influence of interictal epileptiform activity per se on some cognitive functions in newly diagnosed patients with epilepsy (before using anti-seizure medications)
2. Determine different effects among different brain areas (producing epileptiform activity) on specific cognitive domains Type of the study: Case control Study Study Setting: Assiut university hospital -Neuropsychiatry hospital- Out patient clinics.

Study subjects: Will include epilepsy patients that diagnosed according to the International League Against Epilepsy criteria, 2017:

Study tools All patients included in this study will be subjected to: -

1. History taking including Personal history, history of present illness, therapeutic history, past history and family history

2. Complete physical examination. 3) Neurological examination. 4) Digital electroencephalography (EEG) for an hour (16 channels). 5) Psychiatric assessment: all subjects included in the study will be asked to perform a series of psychological tests done by expert psychologist to detect cognitive impairment

   1. Montreal Cognitive Assessment(MoCA).
   2. Hamilton Depression Rating Scale (HDRS).

• Study Type: Interventional
• Enrollment (Anticipated): 98
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shady Mohamed Safwat Mohamed T Hassan, MD; Phone Number: 00201008763141; Email: Shady.hassan@aun.edu.eg
• Study Contact Backup: Name: Mohamed Abdelmegid; Phone Number: 0882080150; Email: mohamedmagee2030@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt
    • Shady Mohamed Safwat Mohamed Tawfik Hassan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Epilepsy; Newly diagnosed epileptic patients	Diagnostic test: Digital electroencephalography (EEG) for an hour (16 channels); Digital electroencephalography (EEG) for an hour (16 channels)
Sham Comparator: Control; healthy subjects	Diagnostic test: Digital electroencephalography (EEG) for an hour (16 channels); Digital electroencephalography (EEG) for an hour (16 channels)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluate the effect of some High frequency epileptiform discharges measured by HZ on some cognitive domines using electroencephalogram	2 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: October 2, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2021
• Last Update Submitted That Met QC Criteria: October 2, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Cognition Disorders; Epilepsy; Cognitive Dysfunction
• Other Study ID Numbers: Epilepsy and Cognition

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No