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CompletedNCT03587506EpilepsyUpdated Jul 16, 2018

Periodic Limb Movement and Genetic Generalized Epilepsy

An observational study in Epilepsy Generalized Idiopathic Not Intractable, sponsored by University of Alexandria. Completed. Open to participants aged 9 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-16.

Sponsored by University of Alexandria · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
9 Years to 29 Years
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Epilepsy Generalized Idiopathic Not Intractable

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Keywords

  • Generalized epilepsy, idiopathic, periodic limb movement
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In context

Epilepsy, Generalized

39 studies on the registry are indexed under Epilepsy, Generalized; 4 are open to participants now.

This study's enrollment of 60 is below the median of 80 across 13 observational studies indexed under Epilepsy, Generalized.

Browse Epilepsy, Generalized studies →

Lead sponsor

University of Alexandria is the lead sponsor of 59 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
9 Years to 29 Years
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. Seizure recurrence

    Clinical major or minor seizure, and electrical seizure

    Time frame: 6 months

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 28837987 ↗
  • 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. PubMed 9153478 ↗
  • Yazdi Z, Sadeghniiat-Haghighi K, Naimian S, Zohal MA, Ghaniri M. Prevalence of Sleep Disorders and their Effects on Sleep Quality in Epileptic Patients. Basic Clin Neurosci. 2013 Winter;4(1):36-41. PubMed 25337326 ↗
  • Vetrugno R, D'Angelo R, Montagna P. Periodic limb movements in sleep and periodic limb movement disorder. Neurol Sci. 2007 Jan;28 Suppl 1:S9-S14. doi: 10.1007/s10072-007-0733-0. No abstract available. PubMed 17235435 ↗
  • Karadeniz D, Ondze B, Besset A, Billiard M. EEG arousals and awakenings in relation with periodic leg movements during sleep. J Sleep Res. 2000 Sep;9(3):273-7. doi: 10.1046/j.1365-2869.2000.00202.x. PubMed 11012867 ↗
  • Parrino L, Ferri R, Bruni O, Terzano MG. Cyclic alternating pattern (CAP): the marker of sleep instability. Sleep Med Rev. 2012 Feb;16(1):27-45. doi: 10.1016/j.smrv.2011.02.003. Epub 2011 May 26. PubMed 21616693 ↗
  • Allena M, Campus C, Morrone E, De Carli F, Garbarino S, Manfredi C, Sebastiano DR, Ferrillo F. Periodic limb movements both in non-REM and REM sleep: relationships between cerebral and autonomic activities. Clin Neurophysiol. 2009 Jul;120(7):1282-90. doi: 10.1016/j.clinph.2009.04.021. Epub 2009 Jun 7. PubMed 19505849 ↗
  • Berg AT, Millichap JJ. The 2010 revised classification of seizures and epilepsy. Continuum (Minneap Minn). 2013 Jun;19(3 Epilepsy):571-97. doi: 10.1212/01.CON.0000431377.44312.9e. PubMed 23739099 ↗
  • Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14. PubMed 24730690 ↗
  • Jagannath A, Peirson SN, Foster RG. Sleep and circadian rhythm disruption in neuropsychiatric illness. Curr Opin Neurobiol. 2013 Oct;23(5):888-94. doi: 10.1016/j.conb.2013.03.008. Epub 2013 Apr 23. PubMed 23618559 ↗
  • 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. PubMed 12067321 ↗
  • Glauser T, Ben-Menachem E, Bourgeois B, Cnaan A, Guerreiro C, Kalviainen R, Mattson R, French JA, Perucca E, Tomson T; ILAE Subcommission on AED Guidelines. Updated ILAE evidence review of antiepileptic drug efficacy and effectiveness as initial monotherapy for epileptic seizures and syndromes. Epilepsia. 2013 Mar;54(3):551-63. doi: 10.1111/epi.12074. Epub 2013 Jan 25. PubMed 23350722 ↗
  • 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. PubMed 16546407 ↗
  • 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. PubMed 8858493 ↗
  • 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. PubMed 10996553 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2015 to primary completion in Sep 2016, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 1, 2018
First posted
Jul 16, 2018
StartActual
Sep 3, 2015
Primary completionActual
Sep 2016
CompletionActual
Dec 2016
Last update
Jul 16, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 16, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03587506
Lead sponsor
University of Alexandria
Responsible party
Eman Hamdy (Assistant lecturer of Neurology, University of Alexandria) — Principal investigator
First posted
Jul 16, 2018
Start date
Sep 3, 2015
Primary completion
Sep 2016
Completion
Dec 2016
Last update
Jul 16, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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