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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01745952
First Posted: December 10, 2012
Last Update Posted: April 26, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
December 4, 2012
December 10, 2012
December 15, 2015
April 26, 2016
April 26, 2016
November 2012
May 2015   (Final data collection date for primary outcome measure)
50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment [ Time Frame: week 12 after each intervention ]
Number of participants achieving a 50% or greater reduction in seizure frequency from baseline
50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment [ Time Frame: week 12 after each intervention ]
Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention.
Complete list of historical versions of study NCT01745952 on ClinicalTrials.gov Archive Site
Percentage of Seizure Reduction After Active rTMS Treatment Compared With Placebo Treatment [ Time Frame: week 12 after each treatment ]
Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention. The average weekly seizure rate was calculated and compared to baseline frequency over all participants.
Percentage of Seizure Reduction After Active rTMS Treatment Compared With Placebo Treatment [ Time Frame: week 12 after each treatment ]
Seizure frequency was recorded in patient diaries and reviewed with the neurologist/epileptologist (outcomes assessor) at visits 12 weeks (+/- 1 week) after each intervention.
  • Alteration of Brain Activation as Measured by 18-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) on Individual Patient Level [ Time Frame: within one week after the last treatment day of each session ]
    Alterations were assessed by visual inspection of PET scans generated by subtracting the baseline individual PET scan from each of the follow-up scans. The subtraction PET scans were overlayed on the anatomical MRI of the patient and the focus of stimulation determined and an sphere with a 1cm radius around this point was analysed.
  • Difference in Seizure Reduction Using Different Coil Types [ Time Frame: 9 months ]
    any difference between the four conditions (baseline/ figure-of-eight treatment/ round coil treatment/ sham treatment) based in negative binomial model for count data
  • 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 ]
    • Quality of life in epilepsy (QOLIE-31): self-report (if cognitive faculties allowed) questionnaire of emotional well-being, social functioning, energy/ fatigue, cognitive functioning, seizure worry, medication effects & overall quality of life. Range 0-100, with higher numbers indicating better quality of life.
    • Global impression of change-scales (score 1-7, with 4 no change and lower/higher numbers implying grade of improvement/worsening) and Visual analogue scale (0-10: no problem to horrible): self-report or parent report about effect of treatment
    • Columbia Suicide Severity Rating Scale (CSSR): structured interview about suicidal risk
    • change in QOLIE scores considered better/worse are based on cut-off reported in DOI 10.1016/j.yebeh.2011.12.023 For global impression of change, the scoring was <4, 4 or >4.
  • Drop Out-rate [ Time Frame: during the 9 months of the study ]
    exclusion by investigator was due to necessity to change drug regimen due to toxicity
  • Adverse Event Rate [ Time Frame: during the 9 months of the study ]
  • 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 ]
  • Difference in Seizure Reduction Using Different Coil Types [ Time Frame: 9 months ]
  • questionnaires: beck-depression inventory-II, quality of life in epilepsy (QOLIE-31) [ Time Frame: before the first treatment of each session and at the last evaluation visit ]
  • Drop Out-rate [ Time Frame: during the 9 months of the study ]
  • Adverse Event Rate [ Time Frame: during the 9 months of the study ]
 
Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)
Multimodal Image-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Refractory Partial Epilepsy.
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.
  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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Epilepsies, Partial
  • Device: figure-of-eight active rTMS coil
    navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil
  • Device: round active rTMS coil
    navigated rTMS over epileptogenic focus using round active rTMS coil
  • Device: sham rTMS coil (figure-of-eight)
    commercially available placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue
  • 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.
    Intervention: Device: 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.
    Intervention: Device: 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.
    Intervention: Device: sham rTMS coil (figure-of-eight)

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
December 2015
May 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 75 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01745952
s52486
No
Not Provided
Plan to Share IPD: No
Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Van Paesschen Wim, MD, PhD University Hospitals Leuven
Universitaire Ziekenhuizen Leuven
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP