Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)

This study is currently recruiting participants.
Verified December 2012 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01745952
First received: December 4, 2012
Last updated: June 12, 2013
Last verified: December 2012
  Purpose

The investigators will treat patients with fully characterized refractory unifocal neocortical epilepsy with a technique that delivers magnetic waves (transcranial magnetic stimulation, TMS) to the region that causes the epilepsy. Active rTMS applied over the epileptogenic focus will reduce seizure frequency compared with sham rTMS.


Condition Intervention
Epilepsies, Partial
Device: figure-of-eight active rTMS coil
Device: round active rTMS coil
Device: sham rTMS coil (figure-of-eight)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multimodal Image-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Refractory Partial Epilepsy.

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 50% responder rate after active rTMS treatment compared with placebo treatment [ Time Frame: week 12 after each intervention ] [ Designated as safety issue: No ]
    Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention.


Secondary Outcome Measures:
  • Percentage of seizure reduction after active rTMS treatment compared with placebo treatment [ Time Frame: week 12 after each treatment ] [ Designated as safety issue: No ]
    Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention.


Other Outcome Measures:
  • alteration of brain activation as measured by FDG-PET on individual patient level [ Time Frame: within one week after the last treatment day of each session ] [ Designated as safety issue: No ]
  • difference in seizure reduction using different coil types [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • questionnaires: quality of life in epilepsy (QOLIE-31), Global impression of change-scales, Visual analogue scale, Columbia Suicide Severity Rating Scale [ Time Frame: before the first treatment of each session and at the last evaluation visit ] [ Designated as safety issue: No ]
  • Drop out-rate [ Time Frame: during the 9 months of the study ] [ Designated as safety issue: Yes ]
  • Adverse event rate [ Time Frame: during the 9 months of the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: November 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: figure-of-eight active rTMS coil
rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
Device: figure-of-eight active rTMS coil
navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil
Experimental: round active rTMS coil
rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
Device: round active rTMS coil
navigated rTMS over epileptogenic focus using round active rTMS coil
Sham Comparator: sham rTMS coil (figure-of-eight)
rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
Device: sham rTMS coil (figure-of-eight)
Magstim placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue

Detailed Description:
  1. Background and study aims

    Epilepsy is a disease that causes repetitive seizures. In 60% of people with epilepsy, these seizures start in a small zone of the brain (focal or partial epilepsy). This zone can be in the depth of the temporal lobe (mesial temporal lobe epilepsy) or in another brain region (neocortical epilepsy). Even with optimal medical care, up to 30% of people with epilepsy continue to have seizures.

    The investigators will treat people with neocortical partial epilepsy with a technique that delivers magnetic waves (transcranial magnetic stimulation, TMS) to the region that causes the epilepsy. The investigators have good reasons to believe that there will be fewer seizures during several weeks after treatment.

  2. Who can participate?

    You have neocortical focal epilepsy. A doctor who specializes in epilepsy made this diagnosis. You had at least one seizure recorded while in an epilepsy monitoring unit. You had an MRI scan of the brain. You can deliver us all the results of the tests you had.

    You continue to have more than 4 seizures a month. You tried a least two different schemes of anti-epileptic drugs as prescribed by your doctor and those schemes were well tolerated. Nevertheless this never cured the seizures.

    You are older than 16 years. You don't plan to become pregnant during the study. You need to faithfully continue your treatment as prescribed by your doctor and don't change the drugs you take from at least 4 weeks before the study until 8 weeks after the last TMS session. You need to be able to keep a diary of your seizures.

  3. What does the study involve?

    You will need to come to the hospital every weekday during two consecutive weeks, every three months during nine months for the TMS-treatment. So you will have three treatment sessions. You will have a brain scan (FDG-PET) before the first treatment and after each session.

    The magnetic pulses will be delivered differently during each of the three treatment sessions: once on a rather small area of the brain, once on a larger brain area and once using a dummy coil, i.e. you will have two active treatment sessions and one dummy or placebo session. The investigators will not tell in which order they deliver the treatments.

  4. What are the possible benefits and risks of participating?

The investigators have good reasons to believe you will have fewer seizures in the weeks following the active treatment.

  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • fully characterized refractory unifocal neocortical epilepsy (i.e. the epileptogenic zone is well defined)
  • on a stable drug regimen for at least one month,
  • able to complete a seizure dairy either by the patient or by a significant other

Exclusion Criteria:

  • Metal in the head including deep brain stimulators, aneurysmal clips, ventricular shunts, cochlear implants, ossicular reconstruction of the middle ear…
  • pacemaker, implantable cardioverter-defibrillator (ICD)
  • psychogenic non-epileptic seizures and other non-epileptic spells
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01745952

Contacts
Contact: Laura Seynaeve, MD +32 16 344280 laura.seynaeve@uzleuven.be
Contact: Wim Van Paesschen, MD, PhD +32 16 344280 wim.vanpaesschen@uzleuven.be

Locations
Belgium
University Hospitals Leuven, department of Neurology Recruiting
Leuven, Belgium, 3000
Contact: Laura Seynaeve, MD    + 32 16 344280    laura.seynaeve@uzleuven.be   
Contact: Wim Van Paesschen, MD, PhD    + 32 16 344280    wim.vanpaesschen@uzleuven.be   
Principal Investigator: Van Paesschen Wim, MD, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Van Paesschen Wim, MD, PhD University Hospitals Leuven
  More Information

Publications:

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01745952     History of Changes
Other Study ID Numbers: s52486
Study First Received: December 4, 2012
Last Updated: June 12, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
Epilepsies, Partial
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 22, 2014