Clinical Trial on Epilepsy Generalized Idiopathic Not Intractable - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Epilepsy Generalized Idiopathic Not Intractable

Detailed Description

Although periodic limb movements are prevalent among patients with epilepsy, the exact relationship between these movements and epilepsy remains elusive. Objective: The aim of this work was to study the periodic limb movements among patients with genetic generalized epilepsy in relation to different clinical characteristics and seizure recurrence. Methods: Sixty individuals participated in this study: thirty of them were newly diagnosed with genetic generalized epilepsy and thirty were healthy individuals. Sleep quality was assessed using the Pittsburgh Sleep Quality Index questionnaire, and a standard polysomnographic study was conducted to all subjects. All patients then received sodium valproate in therapeutic doses and were followed up for six months. Electroencephalogram (EEG) was done after the follow-up period and seizure recurrence was assessed. Accordingly, patients were classified into three groups according to clinical seizure recurrence and follow-up EEG findings.

Periodic limb movement index and frequency were compared among the patients' groups and were correlated with different clinical characteristics.

Study Type

Observational

Enrollment (Actual)

60

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Thirty patients and thirty volunteer healthy controls were recruited. Patients were newly diagnosed with genetic generalized epilepsy according to the ILAE 2010 criteria who did not previously receive AEDs. The clinical seizures were either eye-witnessed by physicians or video-recorded to ensure they were true epileptic seizures. Age of participants ranged from 9 to 29 years. All patients recruited in this study had at least two unprovoked seizures occurring >24 hours apart. Patients with pre-existing psychiatric illnesses those with seizures due to toxic or metabolic causes ), infections, or structural causes, and those using hypnotic drugs were excluded. The control subjects were healthy volunteers who were not related to the patients and had no family history of epilepsy.

Description

Inclusion Criteria:

Newly diagnosed with genetic generalized epilepsy according to the ILAE 2010 criteria
did not previously receive AEDs.
The clinical seizures were either eyewitnessed by physicians or video-recorded to ensure they were true epileptic seizures.
At least two unprovoked seizures occurring >24 hours apart

Exclusion Criteria:

Patients with pre-existing psychiatric illnesses
Patients with seizures due to toxic or metabolic causes (including glucose disturbance, uremia, and electrolytes disturbance), infections, or structural causes (such as neoplasms)
Patients using hypnotic drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
Patients: group Group I (n=10) included patients who did not develop any major or minor seizure during the follow-up period and their follow up EEG was free of any epileptiform discharge
Patients: group II Group II (n=11) included patients who developed only minor seizures and their follow up EEG showed epileptiform discharge
Patients: group III Group III (n=9) were patients who developed one or more major seizures during the follow-up period whatever their EEG findings.
Controls healthy volunteers (n=30) who were not related to the patients and had no family history of epilepsy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seizure recurrence Time Frame: 6 months	Clinical major or minor seizure, and electrical seizure	6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alexandria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 1, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 16, 2018

Study Record Updates

Last Update Posted (Actual)