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

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

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

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 Summary:

  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 tolerabil
    Sponsor: University Hospital, Ghent

    Current Primary Outcome:

    • Seizure diary [ Time Frame: Throughout the study, lasting approximately 4 weeks ]
      Self-reported seizure frequency throughout the study as a measure of clinical efficacy.
    • 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.
    • 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.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 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.
    • Adverse events [ Time Frame: Throughout the study, lasting approximately 4 weeks ]
      Assessment of the adverse events associated with rTMS in EPC/SE.


    Original Secondary Outcome: Same as current

    Information By: University Hospital, Ghent

    Dates:
    Date Received: September 18, 2015
    Date Started: February 2015
    Date Completion: February 2020
    Last Updated: September 24, 2015
    Last Verified: September 2015