36 Participants Needed

Acoustic Stimulation for Epilepsy

Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
Must be taking: AEDs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not change your medications for at least 1 month before and during the 3 months of study activities. However, if you are taking psychoactive medications (like SSRIs, antipsychotics, or stimulants), you cannot participate in the trial.

What data supports the effectiveness of the treatment Acoustic 1Hz Stimulation, Sham Background Noise for epilepsy?

Research on ultrasound stimulation, a similar non-invasive technique, shows it can reduce seizure frequency and duration in both animal models and human tissues, suggesting potential benefits for epilepsy treatment.12345

Is acoustic stimulation safe for humans?

The research primarily involves animal studies, which show that high-intensity sound can induce seizures in seizure-prone rats and mice. While these studies do not directly address human safety, they suggest caution when using high-intensity acoustic stimulation, especially in individuals with seizure susceptibility.16789

How does Acoustic 1Hz Stimulation differ from other epilepsy treatments?

Acoustic 1Hz Stimulation is unique because it uses sound to potentially reduce seizure frequency and duration by delivering specific auditory stimuli during epileptic activity, unlike traditional treatments that often involve medication. This approach is non-invasive and leverages the brain's response to sound, offering a novel way to manage seizures without the side effects associated with drugs.14101112

What is the purpose of this trial?

The objective of this study is to test the feasibility and physiological effect of low-frequency (1 Hz) acoustic stimulation delivered during nocturnal NREM sleep in epilepsy patients. The long-term goal is to develop this protocol for daily, long-term use in a home setting, for nocturnal seizure and IED suppression

Research Team

AL

Anli Liu

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for adults aged 18-60 with epilepsy, who experience frequent nocturnal seizures or disturbances in their sleep due to seizure activity. Participants should be fluent in English, have a good cognitive function (MOCA score ≥26), and not be overweight (BMI <30). They shouldn't have hearing issues, sleep disorders, recent travel across time zones, shift work history before the study, or use certain psychoactive medications.

Inclusion Criteria

I experience seizures at night, at least once a week.
Able to provide informed consent
I am being monitored in an adult epilepsy unit.
See 3 more

Exclusion Criteria

You have a body mass index (BMI) of 30 or higher.
My MOCA score is below 26.
You have traveled to a different time zone within the past month.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Monitoring

No use of sound system; patients record seizures in a diary

4 weeks
Inpatient monitoring

Treatment

1 Hz acoustic stimulation applied via headphones during sleep every night

4 weeks
Ambulatory setting

Sham Comparator

Background noise applied via headphones during sleep every night

4 weeks
Home setting

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Acoustic 1Hz Stimulation
  • Sham Background Noise
Trial Overview The study tests low-frequency acoustic stimulation versus sham noise during night-time sleep to see if it can reduce nighttime seizures and related brain activity. The ultimate goal is to create a home-use protocol for people with epilepsy to suppress seizures during sleep.
Participant Groups
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Acoustic 1Hz StimulationExperimental Treatment1 Intervention
1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.
Group II: Baseline Seizure MonitoringActive Control1 Intervention
No use of sound system; Patients record seizures in a diary.
Group III: Sham Background NoisePlacebo Group1 Intervention
Background noise applied via headphones and downloadable phone application during sleep every night.

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+

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

References

The effect of changes in sound pressure level and frequency on the seizure response of audiogenic seizure susceptible rats. [2019]
Transcranial ultrasound stimulation: a possible therapeutic approach to epilepsy. [2011]
Ultrasound Neuromodulation Inhibits Seizures in Acute Epileptic Monkeys. [2021]
Bidirectional Neuronal Control of Epileptiform Activity by Repetitive Transcranial Focused Ultrasound Stimulations. [2023]
Non-invasive ultrasonic neuromodulation of neuronal excitability for treatment of epilepsy. [2021]
Effects of stimulus intensity and stimulus duration during acoustic priming on audiogenic seizures in C57BL/6J mice. [2006]
Audiogenic priming in DBA/2J and C57BL/6J mice: interactions among age, prime-to-test interval and index of seizure. [2006]
Sounds with harmonic spectra are more effective than pure tones in inducing audiogenic seizure in rats. [2019]
[Potentiation of metaphit-induced audiogenic epilepsy with N-methyl-D-aspartate in rats]. [2013]
10.United Statespubmed.ncbi.nlm.nih.gov
The effect of auditory stimulation on epileptogenic electroencephalographic activity. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Sensory stimulation for inhibition of epileptic seizures. [2019]
[Usefulness of a strain of mice with genetically determined audiogenic epilepsy as a model of experimental epilepsy]. [2015]
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