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

Primary Purpose

Cognitive Impairment, Epilepsy

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Digital electroencephalography (EEG) for an hour (16 channels)
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cognitive Impairment

Eligibility Criteria

10 Years - 50 Years (Child, Adult)All SexesAccepts 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.

Sites / Locations

  • Shady Mohamed Safwat Mohamed Tawfik Hassan

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Sham Comparator

Arm Label

Epilepsy

Control

Arm Description

Newly diagnosed epileptic patients

healthy subjects

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 20, 2021
Last Updated
October 2, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT05068323
Brief Title
Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
Official Title
Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2021 (Anticipated)
Primary Completion Date
May 1, 2022 (Anticipated)
Study Completion Date
June 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This study aims to Evaluate the influence of interictal epileptiform activity per se on some cognitive functions in newly diagnosed patients with epilepsy (before using anti-seizure medications) 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: - History taking including Personal history, history of present illness, therapeutic history, past history and family history 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 Montreal Cognitive Assessment(MoCA). Hamilton Depression Rating Scale (HDRS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment, Epilepsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
case control
Masking
Participant
Allocation
Non-Randomized
Enrollment
98 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epilepsy
Arm Type
Other
Arm Description
Newly diagnosed epileptic patients
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
healthy subjects
Intervention Type
Diagnostic Test
Intervention Name(s)
Digital electroencephalography (EEG) for an hour (16 channels)
Intervention Description
Digital electroencephalography (EEG) for an hour (16 channels)
Primary Outcome Measure Information:
Title
Evaluate the effect of some High frequency epileptiform discharges measured by HZ on some cognitive domines using electroencephalogram
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shady Mohamed Safwat Mohamed T Hassan, MD
Phone
00201008763141
Email
Shady.hassan@aun.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Abdelmegid
Phone
0882080150
Email
mohamedmagee2030@gmail.com
Facility Information:
Facility Name
Shady Mohamed Safwat Mohamed Tawfik Hassan
City
Assiut
Country
Egypt

12. IPD Sharing Statement

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

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