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Periodic Limb Movement and Genetic Generalized Epilepsy (Epilepsy)

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ClinicalTrials.gov Identifier: NCT03587506
Recruitment Status : Completed
First Posted : July 16, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Eman Hamdy, University of Alexandria

Brief Summary:
The study aimed to study the correlation between periodic limb movement occurring during sleep and the different parameters of genetic generalized epilepsy

Condition or disease
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.


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Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship Between Periodic Limb Movement and Seizure Recurrence in Genetic Generalized Epilepsy
Actual Study Start Date : September 3, 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

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.



Primary Outcome Measures :
  1. Seizure recurrence [ Time Frame: 6 months ]
    Clinical major or minor seizure, and electrical seizure



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Ages Eligible for Study:   9 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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

Publications:

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Responsible Party: Eman Hamdy, Assistant lecturer of Neurology, University of Alexandria
ClinicalTrials.gov Identifier: NCT03587506     History of Changes
Other Study ID Numbers: Alexandria Faculty of Medicine
First Posted: July 16, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eman Hamdy, University of Alexandria:
Generalized epilepsy, idiopathic, periodic limb movement
Additional relevant MeSH terms:
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Epilepsy
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases