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

Trial Summary

What is the purpose of this trial?

The investigators are recruiting children with Rolandic epilepsy and children without epilepsy (aged 4 years old and above) for a non-invasive brain imaging study using Magnetic Resonance Imaging (MRI), Magnetoencephalography/Electroencephalography (MEG/EEG), and experimental tasks. The investigators hope to determine the brain circuits and brain rhythms affected in these children and ultimately identify new treatment options for childhood epilepsy patients.

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 data supports the effectiveness of the treatment Auditory stimulation for Rolandic Epilepsy?

Research shows that auditory stimulation can reduce seizure duration and frequency in individuals with epilepsy, as seen in a study where a patient's seizures decreased from 5.70 to 2.66 per day. Additionally, specific auditory stimuli have been found to evoke anti-seizure brain activity in patients with neurological conditions. ^{1 2 3 4 5}

Is auditory stimulation safe for humans?

Auditory stimulation has been used in studies to reduce seizures in individuals with neurological conditions, and no specific safety concerns have been reported in these studies. ^{1 2 3 4 6}

How does auditory stimulation treatment differ from other treatments for rolandic epilepsy?

Auditory stimulation for rolandic epilepsy is unique because it uses specific sounds or music to activate the brain and reduce seizures, unlike traditional treatments that often involve medication. This approach is non-invasive and leverages the brain's response to sound to help control seizure activity. ^{1 2 3 7 8}

Research Team

Catherine J Chu, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The effect of auditory stimulation on epileptogenic electroencephalographic activity. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Cortical auditory dysfunction in benign rolandic epilepsy. [2014]

3. United States pubmed.ncbi.nlm.nih.gov

Reduction of seizure occurrence from exposure to auditory stimulation in individuals with neurological handicaps: a randomized controlled trial. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Evidence for augmented brainstem activated forebrain seizures in Wistar Audiogenic Rats subjected to transauricular electroshock. [2006]

5. Ireland pubmed.ncbi.nlm.nih.gov

Anti-epileptiform effects of audiogenic seizure priming on in vitro kindling in rat hippocampus. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Benign rolandic epilepsy of childhood and central auditory processing disorder: A noncasual neurophysiological association. [2019]

7. Denmark pubmed.ncbi.nlm.nih.gov

40-Hz auditory stimulation for intracranial interictal activity: A pilot study. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Scalp topography and source analysis of interictal spontaneous spikes and evoked spikes by digital stimulation in benign rolandic epilepsy. [2019]