NCT02560597

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 3, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 15, 2022

Status Verified

January 1, 2022

Enrollment Period

3.1 years

First QC Date

September 18, 2015

Last Update Submit

January 31, 2022

Conditions

Epilepsia Partialis ContinuaStatus Epilepticus

Keywords

epilepsyepilepsia partialis continuastatus epilepticustreatment resistantrepetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (2)

  • 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

Study Arms (1)

repetitive transcranial magnetic stimulation

EXPERIMENTAL

rTMS delivered over the epileptogenic focus

Procedure: repetitive transcranial magnetic stimulation

Interventions

repetitive transcranial magnetic stimulationPROCEDURE

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.

repetitive transcranial magnetic stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Epilepsia partialis continua or refractory status epilepticus
  • Prior investigations (EEG, MRI...) show a well-defined neocortical epileptogenic focus
  • Informed consent signed by the patient or his/her legal representative

You may not qualify if:

  • Pregnancy, short-term birth wish or childbearing age without adequate birth control
  • Intracranial metal hardware (excluding dental filling): surgical clips, shrapnell, electrodes under the stimulation area
  • Presence of pacemaker, implantable cardioverter-defibrillator (ICD), permanent medication pumps, cochlear implants or deep brain stimulation (DBS)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Ghent

Ghent, 9000, Belgium

Location

Related Publications (7)

  • 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.

    PMID: 18832045BACKGROUND

  • 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.

    PMID: 15564059BACKGROUND

  • 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.

    PMID: 15946689BACKGROUND

  • 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.

    PMID: 23876929BACKGROUND

  • 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.

    PMID: 22981238BACKGROUND

  • 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.

    PMID: 15016013BACKGROUND

  • 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.

    PMID: 25573025BACKGROUND

MeSH Terms

Conditions

Epilepsia Partialis ContinuaStatus EpilepticusEpilepsy

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain DiseasesCentral Nervous System Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Alfred Meurs, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Boon

Study Record Dates

First Submitted

September 18, 2015

First Posted

September 25, 2015

Study Start

February 3, 2015

Primary Completion

March 1, 2018

Study Completion

September 1, 2018

Last Updated

February 15, 2022

Record last verified: 2022-01

Locations

BE(1)