Acoustic Stimulation for Epilepsy

Overseen By Evan Shen

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Cognition-affecting medications

Disqualifiers: Severe sleep apnea, other neurological disorders

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

Compensation: Varies

Number of Visits: 3

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Focal Epilepsy (FE) patients and healthy controls will wear an actigraph at home for one week and a home sleep study device at home for one night. Participants will then undergo two nights of testing (at least one week apart) at California Sleep Solutions (CSS) in Sacramento, CA. During the overnight stays, participants will have EEG leads placed and possibly a headband. They will undergo cognitive testing before they go to sleep and again in the morning. During one night of testing, sounds will be played in the room (acoustic stimulation). The sounds should not wake the participants.

Will I have to stop taking my current medications?

The trial excludes participants who are currently using medications that can significantly affect cognition, so you may need to stop taking such medications to participate.

What data supports the effectiveness of the treatment Acoustic Stimulation for Epilepsy?

Research shows that simple acoustic stimuli can promptly stop seizures in some patients, and auditory stimulation has been found to reduce both the duration and frequency of seizures in a patient with epilepsy. ^{1 2 3 4 5}

Is acoustic stimulation safe for humans?

Research on acoustic stimulation for epilepsy in humans shows it can reduce seizure frequency and duration without reported safety issues. However, studies in rats indicate that repeated exposure to high-intensity sound can lead to more severe seizures, suggesting caution in its application. ^{2 3 4 6 7}

How does acoustic stimulation treatment for epilepsy differ from other treatments?

Acoustic stimulation for epilepsy is unique because it uses sound to reduce or prevent seizures by activating the brain in a specific way, unlike traditional treatments that often rely on medication. This method involves delivering sound stimuli at the onset of seizures or during sleep, which can decrease seizure frequency and duration without the need for drugs. ^{2 4 6 8 9}

Eligibility Criteria

This trial is for adults aged 18-40 with Focal Epilepsy who can follow directions and have no other significant neurological disorders affecting cognition. Participants will be tested in Sacramento, CA, wearing an actigraph and sleep study device.

Inclusion Criteria

I have been diagnosed with focal epilepsy.

I can follow all instructions and cooperate fully.

I do not have any major brain disorders affecting my thinking.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Home Monitoring

Participants wear an actigraph at home for one week and a home sleep study device for one night

1 week

Home-based

Overnight Testing

Participants undergo two nights of testing at California Sleep Solutions with EEG monitoring and cognitive testing

2 nights (at least one week apart)

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Remote follow-up

Treatment Details

Interventions

• Acoustic Stimulation (AS)
• SHAM Stimulation

Trial Overview The study tests how acoustic stimulation during sleep affects epilepsy patients' brain activity and cognition compared to a sham (fake) treatment. It involves overnight stays with EEG monitoring and cognitive testing before sleeping and in the morning.

Participant Groups

Group I: Acoustic Stimulation (AS) Active Control 1 Intervention

Participants in this arm will be exposed to acoustic stimulation while they sleep during a night of monitoring.

Group II: SHAM Stimulation Placebo Group 1 Intervention

Participants in this arm will not be exposed to any stimulation while they have their sleep monitored for one night.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

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]

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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Treatment of epilepsy: peripheral and central stimulation techniques]. [2021]

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

Sensory stimulation for inhibition of epileptic seizures. [2019]

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

The effect of changes in sound pressure level and frequency on the seizure response of audiogenic seizure susceptible rats. [2019]

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

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

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

Effects of direct brain stimulation depend on seizure dynamics. [2010]

6. Ireland pubmed.ncbi.nlm.nih.gov

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

7. Serbia pubmed.ncbi.nlm.nih.gov

[Potentiation of metaphit-induced audiogenic epilepsy with N-methyl-D-aspartate in rats]. [2013]

8. 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]

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

Protocol for spike-triggered closed-loop auditory stimulation during sleep in patients with epilepsy. [2022]