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

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05068323
• Other study ID #: Epilepsy and Cognition
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: Shady Mohamed Safwat Mohamed T Hassan, MD
• Phone: 00201008763141
• Email: Shady.hassan[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 98
• Est. completion date: June 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Epilepsy

Intervention

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

Locations

Country	Name	City	State
Egypt	Shady Mohamed Safwat Mohamed Tawfik Hassan	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the effect of some High frequency epileptiform discharges measured by HZ on some cognitive domines using electroencephalogram		2 months