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

NCT01745952 | Completed Results

• 1 other identifier: s52486
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. Active rTMS applied over the epileptogenic focus will reduce seizure frequency compared with sham rTMS.

Conditions

Epilepsies, Partial

Keywords

Epilepsies, Partial; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• 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

  week 12 after each intervention

Secondary Outcomes (1)

• Seizure Frequency After Active rTMS Treatment Compared With Placebo Treatment

  week 12 after each treatment

Other Outcomes (5)

• Alteration of Brain Activation as Measured by 18-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) on Individual Patient Level

  within one week after the last treatment day of each session

• Difference in Seizure Reduction Using Different Coil Types

  9 months

• Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale

  before the first treatment of each session and at the last evaluation visit

Study Arms (3)

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.

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.

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.

Device: sham rTMS coil (figure-of-eight)

Interventions

figure-of-eight active rTMS coil DEVICE

navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil

figure-of-eight active rTMS coil

round active rTMS coil DEVICE

navigated rTMS over epileptogenic focus using round active rTMS coil

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

sham rTMS coil (figure-of-eight)

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven, department of Neurology

Leuven, 3000, Belgium

Location

Related Publications (13)

• 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.

  PMID: 22950513 BACKGROUND

• Fregni 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.

  PMID: 17068786 BACKGROUND

• Theodore 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.

  PMID: 12196649 BACKGROUND

• Cantello 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.

  PMID: 17295632 BACKGROUND

• Tergau 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.

  PMID: 10392988 BACKGROUND

• Daniele 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.

  PMID: 12862035 BACKGROUND

• Tergau 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.

  PMID: 14677417 BACKGROUND

• Brasil-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.

  PMID: 15122428 BACKGROUND

• Kinoshita 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.

  PMID: 16046153 BACKGROUND

• Santiago-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.

  PMID: 18495500 BACKGROUND

• Joo 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.

  PMID: 17223384 BACKGROUND

• Seynaeve 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.

  PMID: 26642974 RESULT

• Seynaeve 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.

  PMID: 27492628 RESULT

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Results Point of Contact

• Title: Prof W Van Paesschen & Dr L Seynaeve
• Organization: UZ Leuven

laura.seynaeve@uzleuven.be

+3216349062

Study Officials

• Van Paesschen Wim, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2012
• First Posted: December 10, 2012
• Study Start: November 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: December 31, 2015
• Last Updated: May 11, 2023
• Results First Posted: April 26, 2016

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)