Acoustic Stimulation for Epilepsy

Overseen By Temitayo Oyegbile-Chidi, MD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether playing certain sounds during sleep can help people with focal epilepsy, a seizure disorder affecting one part of the brain. Researchers will monitor participants' sleep while they undergo acoustic stimulation (sound therapy) to assess its impact on brain activity and cognition. Participants will be divided into two groups: one receiving sound therapy and one not. Individuals with focal epilepsy who can follow instructions and are not on medications affecting cognition might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance epilepsy treatment.

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 prior data suggests that acoustic stimulation is safe for epilepsy patients?

Research shows that acoustic stimulation (AS) is usually well-tolerated by people with epilepsy. Studies have demonstrated that this treatment can reduce the frequency and duration of seizures without raising safety concerns. Participants in these studies did not report major side effects, suggesting that AS could be a safe option for those considering this treatment. For those thinking about joining a trial, it is reassuring to know that acoustic stimulation has been tested in humans with positive safety results. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about acoustic stimulation for epilepsy because it offers a non-invasive approach that targets the brain during sleep. Unlike traditional treatments like anti-seizure medications or surgical interventions, acoustic stimulation uses sound waves to potentially modulate brain activity without the need for drugs or surgery. This method could lead to fewer side effects and a more natural way to manage epilepsy, providing a fresh perspective on treatment by harnessing the brain's response to sound during rest.

What evidence suggests that acoustic stimulation is effective for epilepsy?

Research has shown that sound therapy might help manage epilepsy. One study found that certain sounds reduced seizures by an average of 31% and decreased unusual brain activity by 79%. Another study demonstrated a significant 24% drop in seizures during treatment, with benefits continuing even after the treatment ended. In this trial, participants in the Acoustic Stimulation arm will be exposed to specific sounds while they sleep, which may help reduce seizures. Meanwhile, participants in the SHAM Stimulation arm will not receive any sound exposure. These findings suggest that sound could be a promising way to reduce seizures in people with epilepsy. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12227797/

Toward a Tailored Acoustic‐Based Approach in Music ...

These results suggest the potential for music‐based neuromodulation as a personalized therapeutic approach in epilepsy management, emphasizing ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S105913112200214X

Wired for sound: The effect of sound on the epileptic brain

The study ascertained a mean percentage reduction in seizures by 31% and a mean percentage reduction in IEDs by 79% during treatment with K.448. The review ...

3.

withpower.com

withpower.com/trial/phase-epilepsy-4-2023-bf8af

Acoustic Stimulation for Epilepsy

A three-year clinical trial involving patients with neurological impairments demonstrated that passive exposure to specific music significantly reduced seizure ...

4.

frontiersin.org

frontiersin.org/journals/human-neuroscience/articles/10.3389/fnhum.2019.00166/full

Closed-Loop Acoustic Stimulation During Sleep in ...

Our pilot data show that closed-loop acoustic stimulation is feasible and well tolerated in children with spike wave activity during sleep.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/23071510/

Reduction of seizure occurrence from exposure to auditory ...

Subjects exposed to treatment exhibited a significant 24% decrease in seizures during the treatment phase, and a 33% decrease persisting through the follow-up ...

6.

ieeexplore.ieee.org

ieeexplore.ieee.org/iel7/10/9799700/09690005.pdf

Assessing the Feasibility of Acoustic Based Seizure ...

Results: Tested on 667 hours of acoustic data acquired from 15 patients with at least one seizure, the algorithm achieved a detection sensitivity of 88.1% (95% ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04716673?cond=sleep%20epilepsy&rank=8

Stimulation of Sleep in Patients With Epilepsy

The sample size of the study is based on previous publications showing a significant effect of closed-loop auditory stimulation on NREM sleep EEG markers and ...