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

Ghent University Hospital (UZ)

Status: Terminated

Conditions: Status Epilepticus; Epilepsia Partialis Continua

Treatments: Procedure: repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02560597

EC2015/0083

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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4 participants in 1 patient group

repetitive transcranial magnetic stimulation

Experimental group

Description:

rTMS delivered over the epileptogenic focus

Treatment:

Procedure: repetitive transcranial magnetic stimulation