NCT02560597|TerminatedDMC
Study Stopped
Lack of recruitement and finalisation of research on this topic by investigator
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Sponsor study identifier
interventional
4
1 country
1
Study Start
February 3, 2015
Actual (reported)Primary Completion
March 2018
Actual (reported)Study Completion
September 2018
Actual (reported)The purpose of this study is to assess the effects of repetitive transcranial magnetic stimulation (rTMS) as a treatment for Epilepsia Partialis Continua (EPC) or refractory Status Epilepticus (SE), when standard clinical treatments have failed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 3, 2015
Actual (reported)September 18, 2015
Actual (reported)September 25, 2015
Actual (reported)March 2018
Actual (reported)September 2018
Actual (reported)Seizure diary
Self-reported seizure frequency throughout the study as a measure of clinical efficacy.
Throughout the study, lasting approximately 4 weeks
Electrographic epileptiform activity
Interictal or continuous epileptiform activity on EEG is assessed throughout the study as a measure of clinical efficacy.
Throughout the study, lasting approximately 4 weeks, with assessment before treatment (if possible) and after treatment
Neurological examination
Neurological examination assessing consciousness and other cortical functions that are potentially disturbed by the EPC or SE (eg. motor function, speech,...) is performed throughout the study as a measure of clinical efficacy.
Throughout the study, lasting approximately 4 weeks
Duration of the clinical effect
Throughout the study, lasting approximately 4 weeks or as long as the outlasting effect lasts
Adverse events
Throughout the study, lasting approximately 4 weeks
rTMS delivered over the epileptogenic focus
Stimulation over the epileptogenic focus using variable stimulation protocols as described in literature. This protocol may vary case by case, depending on patient characteristics and achieved effect from previous stimulation. In absence of effect, rTMS is given on 5 consecutive days at most.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Hospital, Ghent
Ghent, 9000, Belgium
Rotenberg A, Bae EH, Takeoka M, Tormos JM, Schachter SC, Pascual-Leone A. Repetitive transcranial magnetic stimulation in the treatment of epilepsia partialis continua. Epilepsy Behav. 2009 Jan;14(1):253-7. doi: 10.1016/j.yebeh.2008.09.007. Epub 2008 Oct 30.
Morales OG, Henry ME, Nobler MS, Wassermann EM, Lisanby SH. Electroconvulsive therapy and repetitive transcranial magnetic stimulation in children and adolescents: a review and report of two cases of epilepsia partialis continua. Child Adolesc Psychiatr Clin N Am. 2005 Jan;14(1):193-210, viii-ix. doi: 10.1016/j.chc.2004.07.010.
Alfred Meurs, MD, PhD
University Hospital, Ghent
4 participants (actual enrollment reported by the registry).
First Submitted
September 18, 2015
First Posted
September 25, 2015
Study Start
February 3, 2015
Actual (reported)Contact the study team to confirm eligibility.
Misawa S, Kuwabara S, Shibuya K, Mamada K, Hattori T. Low-frequency transcranial magnetic stimulation for epilepsia partialis continua due to cortical dysplasia. J Neurol Sci. 2005 Jul 15;234(1-2):37-9. doi: 10.1016/j.jns.2005.03.035.
Liu A, Pang T, Herman S, Pascual-Leone A, Rotenberg A. Transcranial magnetic stimulation for refractory focal status epilepticus in the intensive care unit. Seizure. 2013 Dec;22(10):893-6. doi: 10.1016/j.seizure.2013.06.014. Epub 2013 Jul 19.
Thordstein M, Constantinescu R. Possibly lifesaving, noninvasive, EEG-guided neuromodulation in anesthesia-refractory partial status epilepticus. Epilepsy Behav. 2012 Nov;25(3):468-72. doi: 10.1016/j.yebeh.2012.07.026. Epub 2012 Sep 12.
Graff-Guerrero A, Gonzales-Olvera J, Ruiz-Garcia M, Avila-Ordonez U, Vaugier V, Garcia-Reyna JC. rTMS reduces focal brain hyperperfusion in two patients with EPC. Acta Neurol Scand. 2004 Apr;109(4):290-6. doi: 10.1046/j.1600-0404.2003.00222.x.
VanHaerents S, Herman ST, Pang T, Pascual-Leone A, Shafi MM. Repetitive transcranial magnetic stimulation; A cost-effective and beneficial treatment option for refractory focal seizures. Clin Neurophysiol. 2015 Sep;126(9):1840-2. doi: 10.1016/j.clinph.2014.12.004. Epub 2014 Dec 15. No abstract available.
Primary Completion
March 2018
Actual (reported)Study Completion
September 2018
Actual (reported)Last Updated
February 15, 2022
Record last verified: 2022-01
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Source: ClinicalTrials.gov.
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