Epilepsies, PartialNCT01745952
Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)
A study testing figure-of-eight active rTMS coil and round active rTMS coil in people with Epilepsies, Partial, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Epilepsies, Partial
- What is being tested?
- figure-of-eight active rTMS coil and round active rTMS coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2012to 31 Dec 2015
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospitals Leuven, department of Neurology
Leuven, 3000
About this study
Official title: 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.
Read the detailed description
- 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.
- 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.
- 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.
- 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.
- Conditions
- Epilepsies, Partial
- Being tested
- figure-of-eight active rTMS coil, round active rTMS coil, sham rTMS coil (figure-of-eight)
- Keywords
- Epilepsies, Partial, Transcranial Magnetic Stimulation
- Medical subject headings
- Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
figure-of-eight active rTMS coilDevice
navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil
round active rTMS coilDevice
navigated rTMS over epileptogenic focus using round active rTMS coil
sham rTMS coil (figure-of-eight)Device
commercially available placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue
| Study group | Role | What they receive |
|---|---|---|
| figure-of-eight active rTMS coil | Experimental | 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. Receives: Device: figure-of-eight active rTMS coil |
| round active rTMS coil | Experimental | 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. Receives: Device: round active rTMS coil |
| sham rTMS coil (figure-of-eight) | Sham comparator | 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. Receives: Device: sham rTMS coil (figure-of-eight) |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment
Number of participants achieving a 50% or greater reduction in seizure frequency from baseline
Measured: week 12 after each intervention
Secondary outcomes (1)
Seizure Frequency After Active rTMS Treatment Compared With Placebo 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.
Measured: week 12 after each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionMay 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Van Paesschen Wim, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01745952
- Sponsor's protocol ID
- s52486
- Status last verified
- May 2023
- First submitted
- 4 Dec 2012
- Last updated
- 11 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sun W, Mao W, Meng X, Wang D, Qiao L, Tao W, Li L, Jia X, Han C, Fu M, Tong X, Wu X, Wang Y. Low-frequency repetitive transcranial magnetic stimulation for the treatment of refractory partial epilepsy: a controlled clinical study. Epilepsia. 2012 Oct;53(10):1782-9. doi: 10.1111/j.1528-1167.2012.03626.x. Epub 2012 Sep 5.
PubMed 22950513Fregni F, Otachi PT, Do Valle A, Boggio PS, Thut G, Rigonatti SP, Pascual-Leone A, Valente KD. A randomized clinical trial of repetitive transcranial magnetic stimulation in patients with refractory epilepsy. Ann Neurol. 2006 Oct;60(4):447-55. doi: 10.1002/ana.20950.
PubMed 17068786Theodore WH, Hunter K, Chen R, Vega-Bermudez F, Boroojerdi B, Reeves-Tyer P, Werhahn K, Kelley KR, Cohen L. Transcranial magnetic stimulation for the treatment of seizures: a controlled study. Neurology. 2002 Aug 27;59(4):560-2. doi: 10.1212/wnl.59.4.560.
PubMed 12196649Cantello R, Rossi S, Varrasi C, Ulivelli M, Civardi C, Bartalini S, Vatti G, Cincotta M, Borgheresi A, Zaccara G, Quartarone A, Crupi D, Lagana A, Inghilleri M, Giallonardo AT, Berardelli A, Pacifici L, Ferreri F, Tombini M, Gilio F, Quarato P, Conte A, Manganotti P, Bongiovanni LG, Monaco F, Ferrante D, Rossini PM. Slow repetitive TMS for drug-resistant epilepsy: clinical and EEG findings of a placebo-controlled trial. Epilepsia. 2007 Feb;48(2):366-74. doi: 10.1111/j.1528-1167.2006.00938.x.
PubMed 17295632Tergau F, Naumann U, Paulus W, Steinhoff BJ. Low-frequency repetitive transcranial magnetic stimulation improves intractable epilepsy. Lancet. 1999 Jun 26;353(9171):2209. doi: 10.1016/S0140-6736(99)01301-X. No abstract available.
PubMed 10392988Daniele O, Brighina F, Piazza A, Giglia G, Scalia S, Fierro B. Low-frequency transcranial magnetic stimulation in patients with cortical dysplasia - a preliminary study. J Neurol. 2003 Jun;250(6):761-2. doi: 10.1007/s00415-003-1080-6. No abstract available.
PubMed 12862035Tergau F, Neumann D, Rosenow F, Nitsche MA, Paulus W, Steinhoff B. Can epilepsies be improved by repetitive transcranial magnetic stimulation?--interim analysis of a controlled study. Suppl Clin Neurophysiol. 2003;56:400-5. doi: 10.1016/s1567-424x(09)70244-2. No abstract available.
PubMed 14677417Brasil-Neto JP, de Araujo DP, Teixeira WA, Araujo VP, Boechat-Barros R. Experimental therapy of epilepsy with transcranial magnetic stimulation: lack of additional benefit with prolonged treatment. Arq Neuropsiquiatr. 2004 Mar;62(1):21-5. doi: 10.1590/s0004-282x2004000100004. Epub 2004 Apr 28.
PubMed 15122428Kinoshita M, Ikeda A, Begum T, Yamamoto J, Hitomi T, Shibasaki H. Low-frequency repetitive transcranial magnetic stimulation for seizure suppression in patients with extratemporal lobe epilepsy-a pilot study. Seizure. 2005 Sep;14(6):387-92. doi: 10.1016/j.seizure.2005.05.002.
PubMed 16046153Santiago-Rodriguez E, Cardenas-Morales L, Harmony T, Fernandez-Bouzas A, Porras-Kattz E, Hernandez A. Repetitive transcranial magnetic stimulation decreases the number of seizures in patients with focal neocortical epilepsy. Seizure. 2008 Dec;17(8):677-83. doi: 10.1016/j.seizure.2008.04.005. Epub 2008 May 20.
PubMed 18495500Joo EY, Han SJ, Chung SH, Cho JW, Seo DW, Hong SB. Antiepileptic effects of low-frequency repetitive transcranial magnetic stimulation by different stimulation durations and locations. Clin Neurophysiol. 2007 Mar;118(3):702-8. doi: 10.1016/j.clinph.2006.11.008. Epub 2007 Jan 16.
PubMed 17223384Seynaeve L, Devroye A, Dupont P, Van Paesschen W. Randomized crossover sham-controlled clinical trial of targeted low-frequency transcranial magnetic stimulation comparing a figure-8 and a round coil to treat refractory neocortical epilepsy. Epilepsia. 2016 Jan;57(1):141-50. doi: 10.1111/epi.13247. Epub 2015 Dec 8.
PubMed 26642974Seynaeve L, Van Paesschen W. Response to "Safety of repetitive transcranial magnetic stimulation in patients with epilepsy: A systematic review" by Luisa Santos Pereira and colleagues. Epilepsy Behav. 2016 Sep;62:308. doi: 10.1016/j.yebeh.2016.07.002. Epub 2016 Aug 1. No abstract available.
PubMed 27492628