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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-03

Study Completion Date

2018-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Epilepsia Partialis Continua Status Epilepticus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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repetitive transcranial magnetic stimulation

rTMS delivered over the epileptogenic focus

Group Type EXPERIMENTAL

repetitive transcranial magnetic stimulation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No