Transcranial Magnetic Stimulation (rTMS) for Refractory Focal Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2025-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT01745952

Epilepsies, Partial

COMPLETED NA

Transcranial Magnetic Stimulation and Anti-epileptic Effect: Optimization and Evaluation With Electrophysiology.

NCT00382707

Refractory Frontal Lobe Epilepsy

TERMINATED NA

Repetitive Transcranial Magnetic Stimulation (rTMS) for the Treatment of Epilepsy

NCT02560597

Epilepsia Partialis Continua Status Epilepticus

TERMINATED NA

Transcranial Magnetic Stimulation to Treat Epilepsy

NCT00048490

Epilepsy

COMPLETED PHASE2

Treating Deep Seizure Foci With Noninvasive Surface Brain Stimulation

NCT02339376

Epilepsy, Temporal Lobe

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. 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.
2. 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).
3. Inclusion criteria The patients with neocortical focal epilepsy older than 18 years, not controlled with antiseizure drugs, with confirmed refractory epilepsy.
4. 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.
5. 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

See the medical conditions and disease areas that this research is targeting or investigating.

Focal Epilepsy Transcranial Magnetis Stimulation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention/treatment

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

Group Type EXPERIMENTAL

figure-of-eight active rTMS coil device

Intervention Type 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

Control arm

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

Group Type SHAM_COMPARATOR

figure-of-eight sham rTMS coil device

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

figure-of-eight active rTMS coil 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

Intervention Type DEVICE

figure-of-eight sham rTMS coil 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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No