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

January 31, 2022 updated by: Prof. Dr. Kristl Vonck, University Hospital, Ghent

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Epilepsy - Case Study in Patients With Epilepsia Partialis Continua (EPC) and Refractory Status Epilepticus (SE)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • University Hospital, Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: repetitive transcranial magnetic stimulation
rTMS delivered over the epileptogenic focus
Procedure: repetitive transcranial magnetic stimulation

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure diary
Time Frame: Throughout the study, lasting approximately 4 weeks
Self-reported seizure frequency throughout the study as a measure of clinical efficacy.
Throughout the study, lasting approximately 4 weeks
Electrographic epileptiform activity
Time Frame: Throughout the study, lasting approximately 4 weeks, with assessment before treatment (if possible) and after treatment
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
Time Frame: Throughout the study, lasting approximately 4 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the clinical effect
Time Frame: Throughout the study, lasting approximately 4 weeks or as long as the outlasting effect lasts
In case a beneficial clinical effect is obtained, an assessment of the duration of this effect will be performed.
Throughout the study, lasting approximately 4 weeks or as long as the outlasting effect lasts
Adverse events
Time Frame: Throughout the study, lasting approximately 4 weeks
Assessment of the adverse events associated with rTMS in EPC/SE.
Throughout the study, lasting approximately 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Alfred Meurs, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2015

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

September 18, 2015

First Submitted That Met QC Criteria

September 24, 2015

First Posted (Estimate)

September 25, 2015

Study Record Updates

Last Update Posted (Actual)

February 15, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EC2015/0083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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