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Completed

NCT Number: NCT03587506

Periodic Limb Movement and Genetic Generalized Epilepsy

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

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Key information

Age range

9 year–29 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Seizure recurrence

    Time frame: 6 months

    Clinical major or minor seizure, and electrical seizure

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

The Relationship Between Periodic Limb Movement and Seizure Recurrence in Genetic Generalized Epilepsy

Acronym: Epilepsy

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 16, 2018
Registry last updated
Jul 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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