Transcranial Magnetic Stimulation for Rolandic Epilepsy

(TMS4BECTS Trial)

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Prematurity, Serious neurologic problems, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether a non-invasive brain stimulation method, transcranial magnetic stimulation (TMS), can assist children with Benign Epilepsy with Centrotemporal Spikes (BECTS), also known as Rolandic Epilepsy. Although seizures in this condition are mild, many children encounter challenges with language, learning, and attention. The study will assess whether TMS can reduce brain activity spikes linked to these issues and improve language skills. Children who have experienced facial seizures or seizures during sleep and can speak English might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for children with BECTS.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It is best to consult with the trial coordinators for more information.

What prior data suggests that transcranial magnetic stimulation is safe for children with epilepsy?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is generally safe for children with benign epilepsy with centrotemporal spikes (BECTS). Studies have found that rTMS may reduce abnormal brain signals and improve brain function. Importantly, no serious side effects have been reported. Any side effects are usually mild, such as slight discomfort at the stimulation site or a mild headache. Overall, evidence suggests that rTMS is a safe option for children with this type of epilepsy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) for Rolandic Epilepsy is unique because it offers a non-invasive approach to managing seizures. Unlike traditional treatments like anti-seizure medications, which can have various side effects, TMS uses magnetic fields to target specific brain areas involved in seizure activity. Researchers are excited about TMS because it provides a novel way to potentially reduce seizures with fewer side effects and could offer a new option for children who do not respond well to medications.

What evidence suggests that transcranial magnetic stimulation is effective for Rolandic epilepsy?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) may help treat benign epilepsy with centrotemporal spikes (BECTS). Studies have found that rTMS can reduce the number of abnormal brain activities, known as interictal epileptiform discharges (IEDs). These abnormal activities are linked to language and learning problems in children with BECTS. In this trial, children will receive both sham and active rTMS on separate visits. Early results suggest that by reducing the strong connections between brain areas controlling movement and language, which are thought to cause these problems, rTMS could improve language skills in affected children. ^{1 2 3 4 5}

Who Is on the Research Team?

Fiona M Baumer, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for English-speaking children diagnosed with Benign Epilepsy with Centrotemporal Spikes (BECTS), also known as Rolandic Epilepsy, based on specific seizure history and EEG results. It excludes those born prematurely (<35 weeks), with serious neurological issues, focal deficits in neuro exams, or abnormal MRI findings.

Inclusion Criteria

I have been diagnosed with Rolandic Epilepsy based on my seizure history and EEG results.

English-speaking

Exclusion Criteria

You have had an MRI that showed unusual changes in your brain.

I have specific areas of weakness or loss of function.

I have had serious brain or nerve problems like seizures, severe head injuries, strokes, or diseases causing brain inflammation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline EEG measurements to assess IED frequency and brain connectivity

1 day

1 visit (in-person)

Treatment

Participants receive sham and active rTMS on 2 separate study visits to assess the impact on IED frequency and brain connectivity

2 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in IED frequency and brain connectivity after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active rTMS
• rTMS
• Sham rTMS

Trial Overview The study tests transcranial magnetic stimulation (TMS) to see if it can improve language by treating brain activity disruptions caused by BECTS. Children will receive repetitive TMS (rTMS) to potentially reduce these disruptions and change how the motor cortex connects to language regions.

How Is the Trial Designed?

Group I: Children with BECTS Experimental Treatment 2 Interventions

Children will receive sham and active rTMS on 2 separate study visits separated by at least 1 week.

Active rTMS is already approved in United States, European Union for the following indications:

Approved in United States as rTMS for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Smoking Cessation
• Chronic Pain Syndrome

Approved in European Union as rTMS for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Chronic Pain Syndrome
• Generalized Anxiety Disorder (GAD)
• Bipolar Disorder

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Published Research Related to This Trial

In a study involving seven adult patients with medically intractable extratemporal lobe epilepsy, low-frequency rTMS (0.9 Hz) for one week led to a reduction in seizure frequency, with complex partial seizures decreasing by 35.9%.

Patients who had a smaller difference between resting motor threshold and active motor threshold before rTMS experienced a greater reduction in complex partial seizures, suggesting that individual motor threshold measurements may help predict treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-frequency repetitive transcranial magnetic stimulation for seizure suppression in patients with extratemporal lobe epilepsy-a pilot study. Kinoshita, M., Ikeda, A., Begum, T., et al.[2014]

A single session of repetitive transcranial magnetic stimulation (rTMS) effectively reduced epileptiform activity in two patients with epilepsy, as indicated by decreased brain perfusion in the targeted area after treatment.

One patient experienced a significant reduction in seizure frequency, with seizures becoming intermittent and stopping within 24 hours, while the other showed only minimal improvement, highlighting the need for further research to confirm these findings in a larger group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

rTMS reduces focal brain hyperperfusion in two patients with EPC. Graff-Guerrero, A., Gonzáles-Olvera, J., Ruiz-García, M., et al.[2019]

In a young adult with drug-resistant bilateral temporal lobe epilepsy, low frequency repetitive TMS (rTMS) using specially designed H-coils significantly reduced seizure frequency by 50 to 70% after three treatment courses of varying lengths (10, 15, and 30 sessions).

The rTMS treatment was well-tolerated, indicating it is a safe option for patients who do not respond to conventional epilepsy medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

H-coil repetitive transcranial magnetic stimulation for treatment of temporal lobe epilepsy: A case report. Gersner, R., Oberman, L., Sanchez, MJ., et al.[2020]

Repetitive transcranial magnetic stimulation (rTMS) was found to be safe for a patient with an implanted subdural cortical electrode, showing no serious adverse effects during treatment.

Ex-vivo experiments indicated that rTMS caused only a slight increase in coil temperature and no displacement of the electrodes, suggesting that rTMS can be safely applied in clinical settings for patients with such implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of repetitive transcranial magnetic stimulation in patients with implanted cortical electrodes. An ex-vivo study and report of a case. Phielipp, NM., Saha, U., Sankar, T., et al.[2019]

Repetitive transcranial magnetic stimulation (rTMS) has gained popularity for its ability to modulate brain activity, but safety considerations are crucial, especially with the recent updates to safety guidelines published in 2021.

The guidelines emphasize the importance of screening for risks, monitoring for adverse events, and specific safety measures when using rTMS, particularly in patients with conditions like stroke and traumatic brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Kim, WS., Paik, NJ.[2023]

The pilot study involving 9 participants tested the safety and tolerability of low-frequency rTMS for treating temporal lobe epilepsy, showing that it was well-tolerated with no major adverse events reported.

While some participants experienced seizures during both active and sham stimulation, the results suggest that a larger trial is needed to further evaluate the efficacy and safety of this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Report of the Safety and Tolerability of 1 Hz Repetitive Transcranial Magnetic Stimulation in Temporal Lobe Epilepsy. Gersner, R., Oberman, LM., Sanchez, MJ., et al.[2023]

In a patient with medically refractory partial seizures due to focal cortical dysplasia, slow-frequency repetitive transcranial magnetic stimulation (SF-rTMS) led to a remarkable 70% reduction in seizure frequency and a 77% reduction in interictal spikes over a month of treatment.

The treatment was safe and well tolerated, with no seizures occurring during the stimulation sessions, suggesting that SF-rTMS effectively induces cortical inhibition to manage seizure activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Slow-frequency repetitive transcranial magnetic stimulation in a patient with focal cortical dysplasia. Menkes, DL., Gruenthal, M.[2019]

In a study involving 8 patients with refractory epilepsy and malformations of cortical development, low-frequency repetitive transcranial magnetic stimulation (rTMS) significantly reduced epileptiform discharges in EEG by 46.4% and 42.1% at 15 and 30 days post-treatment, respectively.

The treatment also led to a notable decrease in seizure frequency, with reductions of 57.3% and 51.2% over the same time periods, indicating rTMS may be an effective therapeutic option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antiepileptic effects of repetitive transcranial magnetic stimulation in patients with cortical malformations: an EEG and clinical study. Fregni, F., Thome-Souza, S., Bermpohl, F., et al.[2007]

In a study of five patients with intractable epilepsy, three months of low-frequency repetitive transcranial magnetic stimulation (rTMS) treatment led to a significant overall reduction in mean daily number of seizures (MDNS) by 22.8%, indicating some efficacy of this treatment.

The most notable improvement was observed in a patient with focal cortical dysplasia, who experienced a 43.09% reduction in seizures, suggesting that rTMS may be particularly beneficial for patients with specific types of brain lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental therapy of epilepsy with transcranial magnetic stimulation: lack of additional benefit with prolonged treatment. Brasil-Neto, JP., de Araújo, DP., Teixeira, WA., et al.[2019]

Transcranial magnetic stimulation (TMS) has a very low seizure risk, with only 0.08 seizures reported per 1,000 sessions, and less than 0.02 seizures per 1,000 sessions when guidelines are followed for individuals without known risk factors.

The study found that exceeding safety guidelines increases the risk of seizures, and seizures are more likely to occur during the first few TMS sessions, suggesting that TMS is generally safe when administered properly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. Lerner, AJ., Wassermann, EM., Tamir, DI.[2021]

Repetitive transcranial magnetic stimulation (rTMS) has a low risk of inducing seizures in patients with epilepsy, with a crude per subject seizure risk of only 2.9% based on an analysis of 426 subjects.

The majority of adverse events reported (18.3%) were mild, with headaches and dizziness being the most common, indicating that rTMS is generally safe and tolerable for patients with epilepsy, similar to its use in other populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of repetitive transcranial magnetic stimulation in patients with epilepsy: A systematic review. Pereira, LS., Müller, VT., da Mota Gomes, M., et al.[2022]

Repetitive transcranial magnetic stimulation (rTMS) has a low risk of inducing seizures in patients with epilepsy, with only a 1.4% incidence of seizures reported during treatment, primarily linked to low-frequency rTMS.

The majority of adverse events associated with rTMS were mild, with headaches being the most common, occurring in 9.6% of subjects, indicating that rTMS is generally safe and tolerable for individuals with epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of repetitive transcranial magnetic stimulation in patients with epilepsy: a review of the literature. Bae, EH., Schrader, LM., Machii, K., et al.[2007]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35427811/

Repetitive transcranial magnetic stimulation to treat benign ... To investigate the effects of low-frequency repetitive transcranial magnetic stimulation (rTMS) on patients with benign epilepsy with centrotemporal spikes ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04325282

Transcranial Magnetic Stimulation for BECTS In this study, the investigators will use a form of non-invasive brain stimulation called transcranial magnetic stimulation (TMS) to determine the impact of ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X2500049X

Repetitive transcranial magnetic stimulation modulates ... Repetitive transcranial magnetic stimulation (rTMS) is a promising method for reducing both IED frequency and hyperconnectivity in this cohort.

4. medrxiv.org medrxiv.org/content/10.1101/2024.08.27.24312648v2.full-text

Repetitive Transcranial Magnetic Stimulation Modulates ... This study investigates the impact of 1 Hz rTMS on cortical excitability, connectivity, and IED frequency using spTMS-EEG in 19 children with ...

5. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/t/NCT04325282.html

Transcranial Magnetic Stimulation for BECTS * A diagnosis of Benign Epilepsy with Centrotemporal Spikes (BECTS), sometimes called Rolandic Epilepsy. Diagnosis will be based on a history of a focal ...