Transcranial Magnetic Stimulation for Rolandic Epilepsy (TMS4BECTS Trial)
Recruiting in Palo Alto (17 mi)
Overseen ByFiona M Baumer, MD
Age: < 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
No Placebo Group
Trial Summary
What is the purpose of this trial?Benign epilepsy with centrotemporal spikes (BECTS) is the most common pediatric epilepsy syndrome. Affected children typically have a mild seizure disorder, but yet have moderate difficulties with language, learning and attention that impact quality of life more than the seizures. Separate from the seizures, these children have very frequent abnormal activity in their brain known as interictal epileptiform discharges (IEDs, or spikes), which physicians currently do not treat. These IEDs arise near the motor cortex, a region in the brain that controls movement.
In this study, the investigators will use a form of non-invasive brain stimulation called transcranial magnetic stimulation (TMS) to determine the impact of IEDs on brain regions important for language to investigate: (1) if treatment of IEDs could improve language; and (2) if brain stimulation may be a treatment option for children with epilepsy.
Participating children will wear electroencephalogram (EEG) caps to measure brain activity. The investigators will use TMS to stimulate the brain region where the IEDs originate to measure how this region is connected to other brain regions. Children will then receive a special form of TMS called repetitive TMS (rTMS) that briefly reduces brain excitability. The study will measure if IEDs decrease and if brain connectivity changes after rTMS is applied.
The investigators hypothesize that the IEDs cause language problems by increasing connectivity between the motor cortex and language regions. The investigators further hypothesize that rTMS will reduce the frequency of IEDs and also reduce connectivity between the motor and language region
Is the treatment rTMS promising for Rolandic Epilepsy?Yes, rTMS is a promising treatment for epilepsy. Studies show it can reduce seizure frequency and is well-tolerated. It has been effective in decreasing seizures in different types of epilepsy, including temporal lobe epilepsy.235811
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 safety data exists for transcranial magnetic stimulation in epilepsy treatment?Repetitive transcranial magnetic stimulation (rTMS) has been studied for safety in both healthy individuals and those with epilepsy. Safety guidelines have been established since 1996, with updates in 2008 and 2021. rTMS is generally considered safe, but it carries a risk of inducing seizures, especially in epilepsy patients. A systematic review identified 46 studies on rTMS in epilepsy, noting that adverse events are generally mild, with headaches being the most common. The risk of seizures during rTMS is small, with a 1.4% crude per-subject risk, and no life-threatening seizures or status epilepticus reported. Overall, rTMS appears nearly as safe in epilepsy patients as in non-epileptic individuals, warranting further investigation as a therapy.6791012
What data supports the idea that Transcranial Magnetic Stimulation for Rolandic Epilepsy is an effective treatment?The available research shows that Transcranial Magnetic Stimulation (TMS) has been studied for its effects on epilepsy, but not specifically for Rolandic Epilepsy. Some studies have shown that TMS can reduce certain brain activities linked to seizures in other types of epilepsy. For example, one study found that TMS could decrease seizure-related brain activity in patients with focal cortical dysplasia, a different type of epilepsy. Another study suggested that TMS might help reduce brain overactivity in epilepsy. However, there is no specific data provided here that directly supports TMS as an effective treatment for Rolandic Epilepsy.123411
Eligibility Criteria
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.
Exclusion Criteria
I have had serious brain or nerve problems like seizures, severe head injuries, strokes, or diseases causing brain inflammation.
I have specific areas of weakness or loss of function.
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: Children with BECTSExperimental Treatment2 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
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Stanford University School of MedicinePalo Alto, CA
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)Collaborator
References
Slow-frequency repetitive transcranial magnetic stimulation in a patient with focal cortical dysplasia. [2019]To evaluate the effect of slow-frequency repetitive transcranial magnetic stimulation (SF-rTMS) on interictal epileptiform activity and seizure frequency in a patient with medically refractory partial seizures due to focal cortical dysplasia.
rTMS reduces focal brain hyperperfusion in two patients with EPC. [2019]This study was performed to evaluate the acute effect of a single repetitive transcranial magnetic stimulation (rTMS) session in a focal hyperperfusion epileptogenic region to induce a transitory decrease of epileptiform activity.
Experimental therapy of epilepsy with transcranial magnetic stimulation: lack of additional benefit with prolonged treatment. [2019]To investigate the effect of three months of low-frequency repetitive transcranial magnetic stimulation (rTMS) treatment in intractable epilepsy.
Antiepileptic effects of repetitive transcranial magnetic stimulation in patients with cortical malformations: an EEG and clinical study. [2007]To study the effects of repetitive transcranial magnetic stimulation (rTMS) on epileptic EEG discharges in patients with refractory epilepsy and malformations of cortical development (MCDs).
Low-frequency repetitive transcranial magnetic stimulation for seizure suppression in patients with extratemporal lobe epilepsy-a pilot study. [2014]We evaluated the effect of low-frequency repetitive transcranial magnetic stimulation (rTMS) on seizure frequency in adult patients with medically intractable extratemporal lobe epilepsy (ETLE). Seven patients with medically intractable ETLE received low-frequency rTMS at 0.9 Hz, basically two sets of 15 min stimulation per day for five days in a week, with the stimulus intensity of 90% of resting motor threshold (RMT). The number of seizures during two weeks before and after the stimulation of one week was compared. Furthermore, RMT and active motor threshold (AMT) were measured before and after rTMS for each daily session. After low-frequency rTMS of one week, the frequency of all seizure types, complex partial seizures (CPSs) and simple partial seizures was reduced by 19.1, 35.9 and 7.4%, respectively. The patients with smaller difference between RMT and AMT before rTMS had higher reduction rate of CPSs. A favorable tendency of seizure reduction, though not statistically significant, during two weeks after low-frequency rTMS was demonstrated in medically intractable ETLE patients. As far as CPSs are concerned, smaller decrease of motor threshold by voluntary muscle contraction was associated with better response to rTMS.
Safety and tolerability of repetitive transcranial magnetic stimulation in patients with epilepsy: a review of the literature. [2007]Repetitive transcranial magnetic stimulation (rTMS) is emerging as a new therapeutic tool in epilepsy, where it can be used to suppress seizures or treat comorbid conditions such as mood disorder. However, as rTMS carries a risk of inducing seizures among other adverse events, its safety and tolerability in the population with epilepsy warrant distinct consideration, as this group is especially seizure-prone. Accordingly, we performed a review of the literature to estimate the risk of seizures and other adverse events associated with rTMS in patients with epilepsy. We performed an English-language literature search, and reviewed all studies published from January 1990 to February 2007 in which patients with epilepsy were treated with rTMS, and complemented the literature search with personal correspondence with authors when necessary. We identified 30 publications that described patients with epilepsy who underwent rTMS, and noted total number of relevant subjects, medication usage, incidence of adverse events, and rTMS parameters including stimulus frequency, number of stimuli, train duration, intertrain interval, coil type, and stimulation sites. The data were analyzed for adverse events related to rTMS. Crude per-subject risk, as well as per-subject mean risk weighted by sample size and risk per 1000 stimuli weighted by number of stimuli in each study, were computed for seizures and for other adverse events. Adverse events or lack thereof was reported in 26 studies (n=280 subjects). Adverse events attributed to rTMS were generally mild and occurred in 17.1% of subjects. Headache was most common, occurring in 9.6%. The most serious adverse event was seizure during treatment, which occurred in four patients (1.4% crude per-subject risk). All but one case were the patients' typical seizures with respect to duration and semiology, and were associated with low-frequency rTMS. A single case of an atypical seizure appearing to arise from the region of stimulation during high-frequency rTMS is reported. No rTMS-related episodes of status epilepticus were reported. We cautiously conclude that the risk of seizure in patients with epilepsy undergoing rTMS is small, and the risk of other mild adverse events is comparable to that seen when rTMS is used to treat other diseases. Status epilepticus or life-threatening seizures have not been reported in patients undergoing rTMS treatment. rTMS thus appears to be nearly as safe in patients with epilepsy as in nonepileptic individuals, and warrants further investigation as a therapy in this population.
Safety of repetitive transcranial magnetic stimulation in patients with epilepsy: A systematic review. [2022]Approximately one-third of patients with epilepsy remain with pharmacologically intractable seizures. An emerging therapeutic modality for seizure suppression is repetitive transcranial magnetic stimulation (rTMS). Despite being considered a safe technique, rTMS carries the risk of inducing seizures, among other milder adverse events, and thus, its safety in the population with epilepsy should be continuously assessed. We performed an updated systematic review on the safety and tolerability of rTMS in patients with epilepsy, similar to a previous report published in 2007 (Bae EH, Schrader LM, Machii K, Alonso-Alonso M, Riviello JJ, Pascual-Leone A, Rotenberg A. Safety and tolerability of repetitive transcranial magnetic stimulation in patients with epilepsy: a review of the literature. Epilepsy Behav. 2007; 10 (4): 521-8), and estimated the risk of seizures and other adverse events during or shortly after rTMS application. We searched the literature for reports of rTMS being applied on patients with epilepsy, with no time or language restrictions, and obtained studies published from January 1990 to August 2015. A total of 46 publications were identified, of which 16 were new studies published after the previous safety review of 2007. We noted the total number of subjects with epilepsy undergoing rTMS, medication usage, incidence of adverse events, and rTMS protocol parameters: frequency, intensity, total number of stimuli, train duration, intertrain intervals, coil type, and stimulation site. Our main data analysis included separate calculations for crude per subject risk of seizure and other adverse events, as well as risk per 1000 stimuli. We also performed an exploratory, secondary analysis on the risk of seizure and other adverse events according to the type of coil used (figure-of-8 or circular), stimulation frequency (≤ 1 Hz or > 1 Hz), pulse intensity in terms of motor threshold (
H-coil repetitive transcranial magnetic stimulation for treatment of temporal lobe epilepsy: A case report. [2020]Low frequency repetitive TMS (rTMS) of a cortical seizure focus is emerging as an antiepileptic treatment. While conventional rTMS stimulators activate only superficial cortical areas, reaching deep epileptic foci, for example in temporal lobe epilepsy (TLE), is possible using specially designed H-coils. We report the results of rTMS in a young adult with pharmacoresistant bilateral TLE who underwent three courses (of 10, 15, and 30 daily sessions) of unilateral rTMS over the hemisphere from which seizures originated most often. Seizure frequency was assessed before and after each block of rTMS sessions, as was the tolerability of the procedure. Seizure frequency declined significantly, by 50 to 70% following each rTMS course. All sessions were well-tolerated.
Safety of repetitive transcranial magnetic stimulation in patients with implanted cortical electrodes. An ex-vivo study and report of a case. [2019]To evaluate the safety of repetitive transcranial magnetic stimulation (rTMS) in patients with implanted subdural cortical electrodes.
Seizures from transcranial magnetic stimulation 2012-2016: Results of a survey of active laboratories and clinics. [2021]Transcranial magnetic stimulation (TMS) can cause seizures in healthy individuals and patients. However, the rate at which this occurs is unknown. We estimated the risk of seizure and other adverse events with TMS.
Preliminary Report of the Safety and Tolerability of 1 Hz Repetitive Transcranial Magnetic Stimulation in Temporal Lobe Epilepsy. [2023]Low frequency (≤1 Hz) repetitive transcranial magnetic stimulation (rTMS) has been shown to suppress cortical excitability and is beginning to be trialed for the treatment of refractory epilepsy.
Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. [2023]Studies using repetitive transcranial magnetic stimulation (rTMS) in healthy individuals and those with neuropsychiatric diseases have rapidly increased since the 1990s, due to the potential of rTMS to modulate the cortical excitability in the brain depending on the stimulation parameters; therefore, the safety considerations for rTMS use are expected to become more important. Wassermann published the first safety guidelines for rTMS from the consensus conference held in 1996, and Rossi and colleague then published the second safety guidelines from the multidisciplinary consensus meeting held in Siena, Italy in 2008, on behalf of the International Federation of Clinical Neurophysiology. More than 10 years after the second guidelines, the updated third safety guidelines were recently published in 2021. The general safety guidelines for conventional rTMS have not substantially changed. Because the most frequently used rTMS protocol is conventional (low- and high-frequency) rTMS in research and clinical settings, we focus on reviewing safety issues when applying conventional rTMS with a focal cortical stimulation coil. The following issues will be covered: 1) possible adverse events induced by rTMS; 2) checklists to screen for any precautions and risks before rTMS; 3) safety considerations for dosing conventional rTMS; and 4) safety considerations for using rTMS in stroke and traumatic brain injury.