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NCT Number: NCT06681480

Transcranial Magnetic Stimulation (rTMS) for Refractory Focal Epilepsy

Epilepsy as a brain disease is characterised by enhanced brain excitability. Low frequency repetitive transcranial magnetic stimulation (rTMS) can be an effective treatment for refractory focal epilepsy. Today different ways of stimulation were used, the best protocol of rTMS in refractory focal epilepsy is under evaluation. The aim of our study is neuropsychological and electrophysiological evaluation before and after rTMS sessions, the results of rTMS will be compared with VNS outcome in patients, who undergoes VNS implantation after rTMS.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Focal Epilepsy Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases Transcranial Magnetis Stimulation

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

2nd Department of Neurology, Faculty of Medicine COMENIUS UNIVERSITY BRATISLAVA

Bratislava, Slovak Republic, 83305, Slovakia

About this study

  • Background Epilepsy is a chronic disease that causes repetitive seizures. In 60% to 70% of people with epilepsy (PWE) , these seizures start in a small part of the brain (focal epilepsy). Up to 30% of people with epilepsy continue to have seizures despite optimal pharmacological care. Invasive methods - called epilepsy surgery are the choice of treatment for this group of the patients. New non- invasive non- pharmacological methods are on the way.
  • Aim of the study Treatment the people with focal epilepsy with non- invasive transcranial magnetic stimulation (rTMS) to the region that causes the epilepsy. A part of the patients will after that be treated with invasive VNS implantation. The aim is to evaluate neuropsychological and electrophysiological out come in non- invasive arm and in combined arm (VNS after rTMS).
  • Inclusion criteria The patients with neocortical focal epilepsy older than 18 years, not controlled with antiseizure drugs, with confirmed refractory epilepsy.
  • Study methodology The seizure frequency will be controlled with seizure diaries, patients will be evaluated in tertiary epilepsy centre. The patients will be on stable dose of drugs 4 week before and at least 8 weeks after last TMS session. They will be evaluated by battery of neuropsychological tests (cognition, emotions, personality) and electrophysiological methods ( QEEG, SEP n. medianus) before rTMS sessions and after rTMS session and a month later. A part of the patient, who will continue to VNS implantation will be evaluated before VNS implantation and 6 month later again.

The magnetic pulses will be delivered in a active session or in a placebo session ( sham). The investigators will not tell in which order they deliver the treatments.

  • What are the possible benefits and risks of participating? The investigators believe, that the patients will have fewer seizures in the weeks following the active treatment and that the improvement could be detected in neuropsychological evaluations and in electrophysiology. It is not known, if the results of rTMS could predict the response of the patients to VNS stimulation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • fully characterized refractory focal 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, VNS implants pacemaker, implantable cardioverter-defibrillator (ICD) psychogenic non-epileptic seizures and other non-epileptic spells

Treatment and study plan

figure-of-eight active rTMS coil device

Device

rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains with a total of 15000 pulses during 5 weekdays at low frequency 0,5Hz Device: figure-of-eight active rTMS coil navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil, optic navigation system

figure-of-eight sham rTMS coil device

Device

rTMS is administered using the figure-of-eight sham coil, in trains with a total of 15000 pulses during 5 weekdays Device: figure-of-eight sham rTMS coil navigated rTMS over epileptogenic focus using figure-of-eight sham rTMS coil, optic navigation system

Primary outcomes

  1. Seizure frequency and severity

    Time frame: 1 hour

    50% Responder Rate after active rTMS treatment and median of seizure frequency reduction from baseline according seizure diaries of the patients rated per 28 day period

Secondary outcomes

  1. QOLIE-31-P measurement of different neuropsychological aspects of epilepsy

    Time frame: 20 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Questionnaires: Quality of Life in Epilepsy- problems (QOLIE-31-P) change of score

  2. Electrophysiological evaluation with quantitative EEG

    Time frame: 30 min

    Electrophysiological evaluation with quantitative EEG ( QEEG) as response to rTMS stimulation and correlation with primary outcome measure and neuropsychological outcome measured with neuropsychological batteries change in cordance

  3. Comparison the data in the group of the patients

    Time frame: 1 hour

    Comparison the data in the group of the patients, who will after rTMS continue to VNS implantation, multiregression analysis for possible connection between rTMS response and later VNS efficacy

  4. Drop out rate and adverse event profile

    Time frame: 1 hour

    Drop out rate and adverse event profile

  5. LSSS- measurement of different neuropsychological aspects of epilepsy

    Time frame: 10 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Liverpool seizure severity scale (LSSS) change in frequency and severity of seizures

  6. PHQ-9 measurement of different neuropsychological aspects of epilepsy

    Time frame: 5 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Patients Health Questionnaire ( PHQ-9), change of score

  7. GAD-7 measurement of different neuropsychological aspects of epilepsy

    Time frame: 5 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Generalized Anxiety Disorder(GAD-7), change of score

  8. ROCFT measurement of different neuropsychological aspects of epilepsy

    Time frame: 10 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Rey-Osterrieth complex figure test ( ROCFT), change of score

  9. STROOP measurement of different neuropsychological aspects of epilepsy

    Time frame: 15 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Stroop 1,2,3, change of score

  10. TMT AB measurement of different neuropsychological aspects of epilepsy

    Time frame: 5 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Trail making test A,B, (TMT AB), change of score

  11. DST measurement of different neuropsychological aspects of epilepsy

    Time frame: 10 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Digit span test (DST), change of score

  12. AVLT measurement of different neuropsychological aspects of epilepsy

    Time frame: 10 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Auditory verbal learning test ( AVLT), change of score

  13. MoCA measurement of different neuropsychological aspects of epilepsy

    Time frame: 20 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Montreal Cognitive Assessment (MoCA) change of score

  14. SDMT measurement of different neuropsychological aspects of epilepsy

    Time frame: 10 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Symbol Digit Modalities Test (SDMT), change of score

  15. StT measurement of different neuropsychological aspects of epilepsy

    Time frame: 10 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Story Test (StT), change of score

  16. WCST measurement of different neuropsychological aspects of epilepsy

    Time frame: 10 min

    measurement of different neuropsychological aspects of epilepsy (cognition, emotions, social well- being and social functioning) in patients before and one month after rTMS: Wisconsin Card Sorting Test (WCST), change of score

  17. Electrophysiological evaluation with quantitative SEP

    Time frame: 1 hour

    Electrophysiological evaluation with SEP (n. medianus amplitude) as response to rTMS stimulation and correlation with primary outcome measure and neuropsychological outcome measured with neuropsychological batteries change of amplitude

Sponsors and collaborators

Lead sponsor

Comenius University

Other

Registry information

Official study title

Transcranial Magnetic Stimulation (rTMS) for the Treatment of Focal Refractory Epilepsy: Neuropsychological and Electrophysiological Evaluation.

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2024
Registry last updated
Nov 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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