TMS for Temporal Lobe Epilepsy

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must be taking: Antiepileptic drugs

Must not be taking: Antipsychotics, Psychostimulants

Disqualifiers: Neurological illness, Children, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for people with mesial temporal lobe epilepsy (MTLE), a condition that often causes seizures and memory problems. Researchers aim to determine if transcranial magnetic stimulation (TMS), which uses magnetic fields to stimulate the brain, can improve memory and reduce epileptic activity. Participants will undergo tests to measure memory and brain activity before and after receiving TMS. This trial may suit those with MTLE whose symptoms haven't improved with medication. As an unphased trial, it provides a unique opportunity to explore innovative treatment options for MTLE.

Will I have to stop taking my current medications?

The trial requires that participants have a stable antiepileptic drug regimen, meaning your current epilepsy medications should not change for at least one month before joining the study. However, if you are taking other medications that affect cognition, you may not be eligible to participate.

What prior data suggests that this TMS technique is safe for treating temporal lobe epilepsy?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe when used properly. TMS uses magnetic fields to activate nerve cells in the brain and already treats major depression. Studies indicate that TMS is usually well-tolerated, with the most serious risk being a seizure. However, the likelihood of a seizure during TMS is very low, about 0.14% per session, particularly in individuals with central nervous system disorders. This means that out of 1,000 sessions, a seizure might occur in just one or two.

Overall, while some risks exist, professionals consider TMS safe for most people when following guidelines. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for temporal lobe epilepsy, which often involve medications or surgery, Transcranial Magnetic Stimulation (TMS) offers a non-invasive approach. TMS uses magnetic fields to stimulate nerve cells in the brain, potentially reducing seizures without the side effects associated with drugs. Researchers are excited about TMS because it targets brain activity directly and can be precisely controlled, offering a customizable treatment option. Additionally, TMS may provide benefits for cognitive functions, such as memory, which can be affected in epilepsy patients.

What evidence suggests that TMS is effective for temporal lobe epilepsy?

Research has shown that transcranial magnetic stimulation (TMS), which participants in this trial will receive, might help reduce seizures in people with epilepsy. One study found that repetitive TMS reduced monthly seizures by about 50% in patients whose epilepsy did not respond to medication. TMS uses magnetic fields to stimulate brain cells, potentially calming the brain areas linked to seizures. While results can vary, these early findings offer hope for those with difficult-to-treat epilepsy. ^{1 4 5 6 7}

Who Is on the Research Team?

Joel Voss, PhD

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for individuals with a primary diagnosis of mesial temporal lobe epilepsy (MTLE). Participants should be able to undergo neurocognitive testing, fMRI scans, and EEG monitoring. They must also keep a seizure diary for one month. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I am a native English speaker.

My epilepsy medication has been the same for at least a month.

My vision is normal or corrected to normal.

Exclusion Criteria

I am not on any cognition-impairing drugs except for anticonvulsants for MTLE.

I am under 18 years old.

I have a neurological condition that is not mesial temporal lobe epilepsy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Subjects undergo neurocognitive testing, fMRI, and EEG to assess baseline hippocampal network function and epileptic activity

1 day

1 visit (in-person)

Pre-Treatment Monitoring

Subjects complete a daily seizure diary for one month to track baseline seizure frequency

4 weeks

Treatment

Subjects receive up to 5 sessions of high-frequency repetitive TMS targeting the hippocampal network

4 weeks

5 visits (in-person)

Post-Treatment Assessment

Subjects undergo repeat neurocognitive testing, fMRI, and EEG to assess changes from baseline

1 day

1 visit (in-person)

Follow-up

Subjects continue to complete a daily seizure diary for 30 days to track changes in seizure frequency post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Magnetic Stimulation (TMS)

Trial Overview

The study tests if transcranial magnetic stimulation (TMS) can affect memory performance and epileptic activity in MTLE patients by targeting the hippocampal network. It involves baseline assessments, TMS sessions, and follow-up evaluations to measure changes in memory task performance and brain activity.

How Is the Trial Designed?

Group I: Experiment 1 Experimental Treatment 1 Intervention

Subjects will be tested for baseline performance on a memory task while in an MRI scanner and with scalp EEG. Subjects will then receive multiple sessions, of repetitive transcranial magnetic stimulation. Post-treatment, baseline assessments will be repeated. Overall study period per subject: 2 months

Transcranial Magnetic Stimulation (TMS) is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Magnetic Stimulation (TMS) for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)
• Migraine Headache Symptoms

Approved in European Union as Transcranial Magnetic Stimulation (TMS) for:

• Major Depressive Disorder (MDD)
• Obsessive-Compulsive Disorder (OCD)

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Published Research Related to This Trial

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]

Single-pulse transcranial magnetic stimulation (sTMS) has been shown to be a low-risk technique with minimal adverse events, making it a promising option for diagnosing and treating neurological and psychiatric conditions, including migraines.

Extensive clinical experience over two decades indicates that sTMS does not cause harm to brain tissue or neurophysiological function, supporting its safety as a nonpharmacologic treatment for acute migraine headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial magnetic stimulation for migraine: a safety review. Dodick, DW., Schembri, CT., Helmuth, M., et al.[2010]

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 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.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8092469/

Transcranial magnetic stimulation for the treatment of epilepsy

Safety and tolerability of 1 HZ deep repetitive transcranial magnetic stimulation (RTMS) for treatment of temporal lobe epilepsy. Epilepsy Currents 2015;15(1): ...

2.

mayoclinic.org

mayoclinic.org/tests-procedures/transcranial-magnetic-stimulation/about/pac-20384625

Transcranial magnetic stimulation

Transcranial magnetic stimulation (TMS) is a procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of major depression.

3.

frontiersin.org

frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2022.885905/full

Continuous theta burst stimulation for drug-resistant epilepsy

Introduction: Repetitive transcranial magnetic stimulation (rTMS) may have anti-epileptic effects, especially in patients with neocortical ...

4.

seizure-journal.com

seizure-journal.com/article/S1059-1311(25)00187-6/fulltext

A crossover, randomized, single-blinded, sham-controlled ...

Low frequency rTMS significantly reduced monthly seizure frequency in patients with focal drug-resistant epilepsy. •. Active rTMS showed a 50 % ...

5.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0920121124001839

Repetitive transcranial magnetic stimulation in murine ...

Clinical studies of repetitive transcranial magnetic stimulation (rTMS) do not provide consistent efficacy results, possibly due to variability in ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3656498/

Safety and tolerability of repetitive transcranial magnetic ...

Although rTMS is generally safe when following guidelines, seizure induction remains the most serious safety concern (44–46). Analogous to the risks of rTMS in ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0887899416305045

Safety of Transcranial Magnetic Stimulation in Children

Three seizures were found to have occurred in central nervous system disorder individuals during repetitive TMS, with a risk of 0.14% per session. There was no ...