Periodic Limb Movement and Genetic Generalized Epilepsy

NCT ID: NCT03587506

Last Updated: 2018-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-03

Study Completion Date

2016-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Epilepsy Generalized Idiopathic Not Intractable

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Patients: group II

Group II (n=11) included patients who developed only minor seizures and their follow up EEG showed epileptiform discharge

No interventions assigned to this group

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.

No interventions assigned to this group

Controls

healthy volunteers (n=30) who were not related to the patients and had no family history of epilepsy.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Eman Hamdy

Assistant lecturer of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Bazil CW. Sleep and Epilepsy. Semin Neurol. 2017 Aug;37(4):407-412. doi: 10.1055/s-0037-1604352. Epub 2017 Aug 24. No abstract available.

Reference Type BACKGROUND
PMID: 28837987 (View on PubMed)

Malow BA, Fromes GA, Aldrich MS. Usefulness of polysomnography in epilepsy patients. Neurology. 1997 May;48(5):1389-94. doi: 10.1212/wnl.48.5.1389.

Reference Type BACKGROUND
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Reference Type BACKGROUND
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PMID: 17235435 (View on PubMed)

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Reference Type BACKGROUND
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Reference Type BACKGROUND
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Reference Type BACKGROUND
PMID: 23618559 (View on PubMed)

Flink R, Pedersen B, Guekht AB, Malmgren K, Michelucci R, Neville B, Pinto F, Stephani U, Ozkara C; Commission of European Affairs of the International League Against Epilepsy: Subcommission on European Guidelines. Guidelines for the use of EEG methodology in the diagnosis of epilepsy. International League Against Epilepsy: commission report. Commission on European Affairs: Subcommission on European Guidelines. Acta Neurol Scand. 2002 Jul;106(1):1-7. doi: 10.1034/j.1600-0404.2002.01361.x.

Reference Type BACKGROUND
PMID: 12067321 (View on PubMed)

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Reference Type BACKGROUND
PMID: 23350722 (View on PubMed)

Khatami R, Zutter D, Siegel A, Mathis J, Donati F, Bassetti CL. Sleep-wake habits and disorders in a series of 100 adult epilepsy patients--a prospective study. Seizure. 2006 Jul;15(5):299-306. doi: 10.1016/j.seizure.2006.02.018. Epub 2006 Mar 20.

Reference Type BACKGROUND
PMID: 16546407 (View on PubMed)

Parrino L, Boselli M, Buccino GP, Spaggiari MC, Di Giovanni G, Terzano MG. The cyclic alternating pattern plays a gate-control on periodic limb movements during non-rapid eye movement sleep. J Clin Neurophysiol. 1996 Jul;13(4):314-23. doi: 10.1097/00004691-199607000-00005.

Reference Type BACKGROUND
PMID: 8858493 (View on PubMed)

Parrino L, Smerieri A, Spaggiari MC, Terzano MG. Cyclic alternating pattern (CAP) and epilepsy during sleep: how a physiological rhythm modulates a pathological event. Clin Neurophysiol. 2000 Sep;111 Suppl 2:S39-46. doi: 10.1016/s1388-2457(00)00400-4.

Reference Type BACKGROUND
PMID: 10996553 (View on PubMed)

Other Identifiers

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Alexandria Faculty of Medicine

Identifier Type: -

Identifier Source: org_study_id

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