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

A

Assiut University

Status

Unknown

Conditions

Epilepsy
Cognitive Impairment

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT05068323
Epilepsy and Cognition

Details and patient eligibility

About

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.

Full 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).

Enrollment

98 estimated patients

Sex

All

Ages

10 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

98 participants in 2 patient groups

Epilepsy
Other group
Description:
Newly diagnosed epileptic patients
Treatment:
Diagnostic Test: Digital electroencephalography (EEG) for an hour (16 channels)
Control
Sham Comparator group
Description:
healthy subjects
Treatment:
Diagnostic Test: Digital electroencephalography (EEG) for an hour (16 channels)

Trial contacts and locations

1

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Central trial contact

Mohamed Abdelmegid; Shady Mohamed Safwat Mohamed T Hassan, MD

Data sourced from clinicaltrials.gov

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