Clinical trial NCT03587506: Periodic Limb Movement and Genetic Generalized Epilepsy
Official title: The Relationship Between Periodic Limb Movement and Seizure Recurrence in Genetic Generalized Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy Generalized Idiopathic Not Intractable
Keywords: Generalized epilepsy, idiopathic, periodic limb movement
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2018-07-16
Enrollment: 60
Sex: ALL
Minimum age (years): 9
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility 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

Primary outcomes:
measure: Seizure recurrence
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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