Focal EpilepsyNCT06681480
Transcranial Magnetic Stimulation (rTMS) for Refractory Focal Epilepsy
A study testing figure-of-eight active rTMS coil device in people with Focal Epilepsy and Transcranial Magnetis Stimulation, run by Comenius University at 1 site in Slovakia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Focal Epilepsy, Transcranial Magnetis Stimulation
- What is being tested?
- figure-of-eight active rTMS coil device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSlovakia
- Study dates
- 1 Aug 2022to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovakia1 site
2nd Department of Neurology, Faculty of Medicine COMENIUS UNIVERSITY BRATISLAVA
Bratislava, Slovak Republic, 83305
About this study
Official title: Transcranial Magnetic Stimulation (rTMS) for the Treatment of Focal Refractory Epilepsy: Neuropsychological and Electrophysiological Evaluation.
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.
Read the detailed description
- 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.
- Conditions
- Focal Epilepsy, Transcranial Magnetis Stimulation
- Being tested
- figure-of-eight active rTMS coil device, figure-of-eight sham rTMS coil device
- Keywords
- Epilepsy, Focal, Partial, Central Nervous System Diseases, Brain Diseases
- Medical subject headings
- Epilepsies, Partial, Epilepsy, Central Nervous System Diseases, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
figure-of-eight active rTMS coil deviceDevice
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 deviceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention/treatment | 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 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 Receives: Device: figure-of-eight active rTMS coil device |
| Control arm | Sham comparator | figure-of-eight active rTMS coil rTMS is administered using the figure-of-eight sham coil, at 90% of the resting motor threshold over the epileptogenic region, in trains with a total of 15000 pulses during 5 weekdays at sham stimulation Device: figure-of-eight sham rTMS coil navigated rTMS over epileptogenic focus using figure-of-eight sham rTMS coil, optic navigation system Receives: Device: figure-of-eight sham rTMS coil device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure frequency and severity
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
Measured: 1 hour
Secondary outcomes (17)
QOLIE-31-P measurement of different neuropsychological aspects of epilepsy
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
Measured: 20 min
Electrophysiological evaluation with quantitative EEG
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
Measured: 30 min
Comparison the data in the group of the patients
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
Measured: 1 hour
Drop out rate and adverse event profile
Drop out rate and adverse event profile
Measured: 1 hour
LSSS- measurement of different neuropsychological aspects of epilepsy
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
Measured: 10 min
PHQ-9 measurement of different neuropsychological aspects of epilepsy
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
Measured: 5 min
GAD-7 measurement of different neuropsychological aspects of epilepsy
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
Measured: 5 min
ROCFT measurement of different neuropsychological aspects of epilepsy
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
Measured: 10 min
STROOP measurement of different neuropsychological aspects of epilepsy
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
Measured: 15 min
TMT AB measurement of different neuropsychological aspects of epilepsy
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
Measured: 5 min
DST measurement of different neuropsychological aspects of epilepsy
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
Measured: 10 min
AVLT measurement of different neuropsychological aspects of epilepsy
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
Measured: 10 min
MoCA measurement of different neuropsychological aspects of epilepsy
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
Measured: 20 min
SDMT measurement of different neuropsychological aspects of epilepsy
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
Measured: 10 min
StT measurement of different neuropsychological aspects of epilepsy
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
Measured: 10 min
WCST measurement of different neuropsychological aspects of epilepsy
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
Measured: 10 min
Electrophysiological evaluation with quantitative SEP
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start1 Aug 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Focal EpilepsyStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comenius University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681480
- Sponsor's protocol ID
- U-1111-1280-4605
- Other IDs
- UK/33/2022
- Status last verified
- Nov 2024
- First submitted
- 9 Sep 2022
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 17068786Pereira LS, Muller VT, da Mota Gomes M, Rotenberg A, Fregni F. Safety of repetitive transcranial magnetic stimulation in patients with epilepsy: A systematic review. Epilepsy Behav. 2016 Apr;57(Pt A):167-176. doi: 10.1016/j.yebeh.2016.01.015. Epub 2016 Mar 10.
PubMed 26970993Seynaeve 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 26642974Cantello 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 17295632Melus J, Waczulikova I, Hapakova L, Konecna M, Valkovic P, Timarova G. Repetitive transcranial magnetic stimulation for the treatment of focal drug-resistant epilepsy: A crossover, randomized, single-blinded, sham-controlled clinical trial. Seizure. 2025 Sep;131:290-297. doi: 10.1016/j.seizure.2025.07.015. Epub 2025 Jul 27.
PubMed 40782718
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Magnetic Stimulation (rTMS) for the Treatment of Focal Refractory Epilepsy: Neuropsychological and Electrophysiological Evaluation.
- ClinicalTrials.gov ID
- NCT06681480
- Acronym / sponsor ID
- U-1111-1280-4605
- Conditions
- Focal Epilepsy, Transcranial Magnetis Stimulation
- Keywords
- Epilepsy, Focal, Partial, Central Nervous System Diseases, Brain Diseases
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Comenius UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention/treatment | Experimental | Device: figure-of-eight active rTMS coil devicefigure-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 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 |
| Control arm | Sham comparator | Device: figure-of-eight sham rTMS coil devicefigure-of-eight active rTMS coil rTMS is administered using the figure-of-eight sham coil, at 90% of the resting motor threshold over the epileptogenic region, in trains with a total of 15000 pulses during 5 weekdays at sham stimulation Device: figure-of-eight sham rTMS coil navigated rTMS over epileptogenic focus using figure-of-eight sham rTMS coil, optic navigation system |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| figure-of-eight active rTMS coil devicerTMS 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 | Device | Intervention/treatment |
| figure-of-eight sham rTMS coil devicerTMS 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 | Device | Control arm |
Primary outcome
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
17 secondary outcomes
QOLIE-31-P measurement of different neuropsychological aspects of epilepsy
Time frame: 20 min
Electrophysiological evaluation with quantitative EEG
Time frame: 30 min
Comparison the data in the group of the patients
Time frame: 1 hour
Drop out rate and adverse event profile
Time frame: 1 hour
LSSS- measurement of different neuropsychological aspects of epilepsy
Time frame: 10 min
PHQ-9 measurement of different neuropsychological aspects of epilepsy
Time frame: 5 min
GAD-7 measurement of different neuropsychological aspects of epilepsy
Time frame: 5 min
ROCFT measurement of different neuropsychological aspects of epilepsy
Time frame: 10 min
STROOP measurement of different neuropsychological aspects of epilepsy
Time frame: 15 min
TMT AB measurement of different neuropsychological aspects of epilepsy
Time frame: 5 min
DST measurement of different neuropsychological aspects of epilepsy
Time frame: 10 min
AVLT measurement of different neuropsychological aspects of epilepsy
Time frame: 10 min
MoCA measurement of different neuropsychological aspects of epilepsy
Time frame: 20 min
SDMT measurement of different neuropsychological aspects of epilepsy
Time frame: 10 min
StT measurement of different neuropsychological aspects of epilepsy
Time frame: 10 min
WCST measurement of different neuropsychological aspects of epilepsy
Time frame: 10 min
Electrophysiological evaluation with quantitative SEP
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
- Background: PubMed 22950513Sun 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.
- Background: PubMed 17068786Fregni 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.
- Background: PubMed 26970993Pereira LS, Muller VT, da Mota Gomes M, Rotenberg A, Fregni F. Safety of repetitive transcranial magnetic stimulation in patients with epilepsy: A systematic review. Epilepsy Behav. 2016 Apr;57(Pt A):167-176. doi: 10.1016/j.yebeh.2016.01.015. Epub 2016 Mar 10.
- Background: PubMed 26642974Seynaeve 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.
- Background: PubMed 17295632Cantello 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.
- Derived from this study: PubMed 40782718Melus J, Waczulikova I, Hapakova L, Konecna M, Valkovic P, Timarova G. Repetitive transcranial magnetic stimulation for the treatment of focal drug-resistant epilepsy: A crossover, randomized, single-blinded, sham-controlled clinical trial. Seizure. 2025 Sep;131:290-297. doi: 10.1016/j.seizure.2025.07.015. Epub 2025 Jul 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing figure-of-eight active rTMS coil device in people with Focal Epilepsy and Transcranial Magnetis Stimulation, run by Comenius University at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure frequency and severity (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06681480, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2024.