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Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Epilepsy

Primary Purpose

Epilepsia Partialis Continua, Status Epilepticus

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
repetitive transcranial magnetic stimulation
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsia Partialis Continua focused on measuring epilepsy, epilepsia partialis continua, status epilepticus, treatment resistant, repetitive transcranial magnetic stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

Sites / Locations

  • University Hospital, Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

repetitive transcranial magnetic stimulation

Arm Description

rTMS delivered over the epileptogenic focus

Outcomes

Primary Outcome Measures

Seizure diary
Self-reported seizure frequency throughout the study as a measure of clinical efficacy.
Electrographic epileptiform activity
Interictal or continuous epileptiform activity on EEG is assessed throughout the study as a measure of clinical efficacy.
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.

Secondary Outcome Measures

Duration of the clinical effect
In case a beneficial clinical effect is obtained, an assessment of the duration of this effect will be performed.
Adverse events
Assessment of the adverse events associated with rTMS in EPC/SE.

Full Information

First Posted
September 18, 2015
Last Updated
January 31, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT02560597
Brief Title
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Epilepsy
Official Title
Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Epilepsy - Case Study in Patients With Epilepsia Partialis Continua (EPC) and Refractory Status Epilepticus (SE)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of recruitement and finalisation of research on this topic by investigator
Study Start Date
February 3, 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Study design: This is a case study, including up to 10 patients with EPC or refractory SE that are admitted to the service in the coming 5 years. If circumstances permit so, a baseline evaluation of seizure frequency over 1 week and a 24-hour baseline EEG registration will be obtained, as well as a baseline clinical neurologic exam. In case of therapeutic urgency, these baseline measurements will be omitted. The treatment itself consists of multiple stimulation sessions over multiple days, decided upon based on patient characteristics and the obtained effects. In absence of the desired effect, treatment will be repeated during 5 consecutive days at most. Patients will be followed-up clinically and electrographically. In case of therapeutic success, the treatment can be repeated over time when seizures reoccur. Objectives: The primary objective of this study is to evaluate the effect of rTMS on the clinical status of patients with continuous refractory focal seizures (either EPC or SE). A beneficial effect on clinical status is defined as a decrease in seizure frequency or an interruption of continuous electrographic epileptiform activity, as well as an improvement in consciousness or other cortical functions that are disturbed by the EPC or SE (motor function, speech,...). As a secondary objective, the duration of the induced therapeutic effect will be evaluated, as well as the effect of rTMS on epileptiform discharges and the associated side effects and tolerability of the treatment. Stimulation: The exact stimulation protocol will be decided upon case per case, based on similar reports in literature. The optimal stimulation protocol is currently unknown. Rationale: Patients with EPC often have a high number of debilitating seizures per day that are hard to control with anti-epileptic medication. Some cases of SE also do not respond to standard care and require heavy sedation of the patient. Some of these patient may benefit from treatment with rTMS, which is painless, non-invasive and safe and can be administered at bedside. Moreover, in patients with EPC en SE, the (almost) continuous ictal activity allows an immediate effect evaluation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsia Partialis Continua, Status Epilepticus
Keywords
epilepsy, epilepsia partialis continua, status epilepticus, treatment resistant, repetitive transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
repetitive transcranial magnetic stimulation
Arm Type
Experimental
Arm Description
rTMS delivered over the epileptogenic focus
Intervention Type
Procedure
Intervention Name(s)
repetitive transcranial magnetic stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Seizure diary
Description
Self-reported seizure frequency throughout the study as a measure of clinical efficacy.
Time Frame
Throughout the study, lasting approximately 4 weeks
Title
Electrographic epileptiform activity
Description
Interictal or continuous epileptiform activity on EEG is assessed throughout the study as a measure of clinical efficacy.
Time Frame
Throughout the study, lasting approximately 4 weeks, with assessment before treatment (if possible) and after treatment
Title
Neurological examination
Description
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.
Time Frame
Throughout the study, lasting approximately 4 weeks
Secondary Outcome Measure Information:
Title
Duration of the clinical effect
Description
In case a beneficial clinical effect is obtained, an assessment of the duration of this effect will be performed.
Time Frame
Throughout the study, lasting approximately 4 weeks or as long as the outlasting effect lasts
Title
Adverse events
Description
Assessment of the adverse events associated with rTMS in EPC/SE.
Time Frame
Throughout the study, lasting approximately 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred Meurs, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

Citations:
PubMed Identifier
18832045
Citation
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.
Results Reference
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PubMed Identifier
15564059
Citation
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.
Results Reference
background
PubMed Identifier
15946689
Citation
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.
Results Reference
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PubMed Identifier
23876929
Citation
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.
Results Reference
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PubMed Identifier
22981238
Citation
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.
Results Reference
background
PubMed Identifier
15016013
Citation
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.
Results Reference
background
PubMed Identifier
25573025
Citation
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.
Results Reference
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Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Epilepsy

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