Auditory Stimulation for Rolandic Epilepsy

Overseen By Catherine Chu, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Abnormal MRI, Other neurological disease, others

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

Compensation: Varies

Number of Visits: 1

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help children with Rolandic epilepsy by using auditory stimulation (a type of therapy using sound) during naps. Researchers aim to identify which brain areas are affected in children with this type of epilepsy compared to those without it, using brain imaging techniques like MRI and EEG. They hope the study will lead to better treatments for childhood epilepsy. Children aged 4 to 18 with Rolandic epilepsy who experience seizures might be suitable candidates for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatments for childhood epilepsy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that playing sounds while children with Rolandic epilepsy sleep can reduce certain brain activities linked to this condition. Rolandic epilepsy, also known as benign epilepsy with centrotemporal spikes, is common in children and usually resolves by the teenage years. Using sound during sleep is non-invasive, meaning it doesn't involve surgery or entering the body, and children generally tolerate it well. Studies have not reported any major side effects from using sound in similar situations, suggesting it is a safe option for children with this condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using auditory stimulation for rolandic epilepsy because it introduces a non-invasive and innovative approach that differs from traditional treatments like anti-seizure medications. Unlike medications that alter brain chemistry, this method uses closed-loop auditory stimulation during naps to potentially regulate brain activity in a natural and gentle way. The hope is that this technique can reduce seizure frequency without the side effects associated with drugs, offering a safe alternative for children and adolescents with epilepsy.

What evidence suggests that auditory stimulation is effective for Rolandic epilepsy?

Research has shown that playing sounds while children with Rolandic epilepsy sleep can help reduce unusual brain activity. These unusual activities, called interictal spikes, originate from parts of the brain involved in communication. This trial will investigate the effects of auditory stimulation during sleep on these interictal spikes. Studies suggest that reducing these spikes might lower the risk of learning and thinking problems linked to this type of epilepsy. By reducing these spikes, sound therapy might improve the overall brain health of affected children. Although this method is new, early results indicate it could be a promising way to manage symptoms of Rolandic epilepsy. ^{1 6 7 8 9}

Who Is on the Research Team?

Catherine J Chu, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 4-18 with Rolandic epilepsy, who've had at least one seizure and show specific brain activity patterns on an EEG. It's not for those with abnormal MRIs, other neurological diseases, metal implants or braces, claustrophobia, a history of frequent vomiting, or over the MRI weight limit.

Inclusion Criteria

I have had at least one seizure.

You have a specific abnormal brain wave pattern during sleep.

I have been diagnosed with Rolandic epilepsy by a child neurologist.

Exclusion Criteria

I weigh less than or equal to 350lbs.

I often experience vomiting.

You cannot have a magnetic resonance imaging (MRI) or magnetoencephalography (MEG) scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Experimental Task and Imaging

Participants undergo MRI, MEG/EEG, and training on a memory task with auditory stimulation during a nap

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the experimental tasks

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Auditory stimulation

Trial Overview The study is testing auditory stimulation in kids with Rolandic epilepsy using non-invasive brain imaging techniques like MRI and MEG/EEG to understand affected brain circuits and rhythms. The goal is to find new treatments for childhood epilepsy.

How Is the Trial Designed?

Group I: Children and adolescents with epilepsy and controls Experimental Treatment 1 Intervention

Closed loop auditory stimulation during nap

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+

Boston University

Collaborator

Trials

494

Recruited

9,998,000+

Published Research Related to This Trial

Naïve Wistar Audiogenic Rats (WARs) show a greater susceptibility to seizures from electrical stimulation compared to Wistar controls, confirming their genetic predisposition to epilepsy.

The study found that low current electrical stimulation can trigger epileptiform activity in the amygdala of WARs even after initial activity is observed in other brain regions, suggesting enhanced acoustic-limbic circuitry in these rats.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evidence for augmented brainstem activated forebrain seizures in Wistar Audiogenic Rats subjected to transauricular electroshock. Magalhães, LH., Garcia-Cairasco, N., Massensini, AR., et al.[2006]

In a study of 6 children with benign rolandic epilepsy, both spontaneous rolandic spikes and high amplitude scalp responses evoked by finger tapping showed similar electrical patterns and source localization, indicating they may originate from the same cortical areas.

The analysis suggests that the high amplitude sensory evoked potentials (SEPs) could be considered as evoked spikes, reinforcing the understanding of the underlying mechanisms of rolandic epilepsy in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Scalp topography and source analysis of interictal spontaneous spikes and evoked spikes by digital stimulation in benign rolandic epilepsy. Manganotti, P., Miniussi, C., Santorum, E., et al.[2019]

Priming for audiogenic seizures (AGS) through intense auditory stimulation during a critical developmental period in Long-Evans rats led to reduced epileptiform activity in the hippocampus during subsequent testing.

The study found that AGS priming decreased the number of afterdischarges in hippocampal slices, suggesting that this early auditory stimulation can initially lower excitability and alter the brain's response to seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anti-epileptiform effects of audiogenic seizure priming on in vitro kindling in rat hippocampus. Ross, KC., Coleman, JR., Jones, LS.[2019]

Auditory stimulation targeted to the patient's epileptogenic activity significantly reduced both the duration and frequency of seizures, decreasing from 5.70 to 2.66 seizures per day over the course of the study.

In contrast, random auditory stimulation did not produce any beneficial effects on seizure duration or frequency, highlighting the importance of targeted intervention in managing epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of auditory stimulation on epileptogenic electroencephalographic activity. Götestam, KG., Melin, L., Sjödén, PO.[2019]

In a study of 93 children with benign rolandic epilepsy of childhood (BREC), 46.2% were found to have central auditory processing disorders (CAPD), indicating a notable association between the two conditions.

The age at which seizures began did not significantly affect the likelihood of developing CAPD, suggesting that BREC may predispose children to auditory processing issues regardless of seizure onset timing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benign rolandic epilepsy of childhood and central auditory processing disorder: A noncasual neurophysiological association. Matos, M., Bara, T., Clark, S., et al.[2019]

A three-year clinical trial involving patients with neurological impairments demonstrated that passive exposure to specific music significantly reduced seizure rates by 24% during treatment and 33% during follow-up, with some subjects experiencing complete seizure cessation.

The study suggests that auditory stimulation through music can serve as a non-invasive, non-pharmacologic treatment option for epilepsy, supporting previous findings of its anti-seizure effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of seizure occurrence from exposure to auditory stimulation in individuals with neurological handicaps: a randomized controlled trial. Bodner, M., Turner, RP., Schwacke, J., et al.[2021]

Children with benign rolandic epilepsy (BRE) showed normal speech recognition in quiet environments but had significant difficulties in recognizing speech in noisy conditions, indicating specific auditory processing challenges.

Electrophysiological tests revealed that these speech recognition impairments are linked to dysfunction in the nonprimary auditory cortex, rather than just attention issues, highlighting the need for thorough auditory assessments in children with BRE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cortical auditory dysfunction in benign rolandic epilepsy. Boatman, DF., Trescher, WH., Smith, C., et al.[2014]

In a pilot study involving 8 subjects with refractory epilepsy, a 40-Hz auditory tone significantly reduced interictal epileptiform discharge (IED) rates by an average of 35.25% in those with high baseline IED rates, particularly in mesial and lateral temporal brain regions.

This research suggests that 40-Hz auditory stimulation could serve as a noninvasive adjunctive treatment to help manage IEDs in epilepsy, warranting further investigation in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

40-Hz auditory stimulation for intracranial interictal activity: A pilot study. Quon, RJ., Leslie, GA., Camp, EJ., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8606903/

Auditory stimulation during sleep suppresses spike activity in ... Interictal spikes hallmarking benign epilepsy with centrotemporal spikes (BECTS) have been hypothesized to emerge from thalamocortical networks.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7696372/

Childhood Epilepsy with Centrotemporal Spikes: Clinical ... The presence of frequent centrotemporal spikes during sleep has been regarded as an important potential predictor of adverse neuropsychological ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1525505016001402

Comparison of auditory event-related potentials between ... Therefore, this study aimed to analyze the results of P300 in children with benign childhood epilepsy with centrotemporal spikes (BECTS) and temporal lobe ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/brb3.1854

The relationship between epilepsy and cognitive function ... This study was aimed to explore the relationship between neural network changes in newly diagnosed children with Benign Childhood Epilepsy with Centrotemporal ...

5. intechopen.com intechopen.com/chapters/75338

Rolandic Epilepsy: Self-Limited Epilepsy with ... - IntechOpen D'Alessandro et al. investigated the neuropsychological data of 44 children with RE who did not have a seizure for more than 6 months without treatment.

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1525505016304280

Benign childhood epilepsy with centrotemporal spikes ... Many studies reported poor language ability in children with BECTS compared with healthy control children.

7. malacards.org malacards.org/card/benign_epilepsy_with_centrotemporal_spikes

Benign Epilepsy with Centrotemporal Spikes Auditory stimulation during sleep suppresses spike activity in benign epilepsy with centrotemporal spikes. ... epilepsy with centrotemporal spikes aka Rolandic ...

8. epilepsy.com epilepsy.com/what-is-epilepsy/syndromes/childhood-epilepsy-centrotemporal-spikes

Benign Rolandic Epilepsy Childhood epilepsy with centrotemporal spikes is a common form of the condition that usually ceases by adolescence.

9. epilepsysociety.org.uk epilepsysociety.org.uk/sites/default/files/2020-08/Chapter09Koutroumanidis2015_0.pdf

Benign childhood seizure susceptibility syndromes Rolandic epilepsy (benign childhood epilepsy with centrotemporal spikes). Rolandic epilepsy is the best known and commoner benign childhood focal epilepsy2,8-11 ...