Acoustic Stimulation for Epilepsy

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must be taking: AEDs

Must not be taking: SSRIs, Antipsychotics, BDZ, Stimulants

Disqualifiers: Hearing impairment, Sleep disorder, BMI ≥ 30, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

36 Participants Needed

What You Need to Know Before You Apply

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

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{1 8 10 11 12}

Who Is on the Research Team?

Anli Liu

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Acoustic 1Hz Stimulation Experimental Treatment 1 Intervention

1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.

Group II: Baseline Seizure Monitoring Active Control 1 Intervention

No use of sound system; Patients record seizures in a diary.

Group III: Sham Background Noise Placebo Group 1 Intervention

Background noise applied via headphones and downloadable phone application during sleep every night.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

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]

Citations

1. 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]

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

Transcranial ultrasound stimulation: a possible therapeutic approach to epilepsy. [2011]

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

Ultrasound Neuromodulation Inhibits Seizures in Acute Epileptic Monkeys. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Bidirectional Neuronal Control of Epileptiform Activity by Repetitive Transcranial Focused Ultrasound Stimulations. [2023]

5. Australia pubmed.ncbi.nlm.nih.gov

Non-invasive ultrasonic neuromodulation of neuronal excitability for treatment of epilepsy. [2021]

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

Effects of stimulus intensity and stimulus duration during acoustic priming on audiogenic seizures in C57BL/6J mice. [2006]

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

Audiogenic priming in DBA/2J and C57BL/6J mice: interactions among age, prime-to-test interval and index of seizure. [2006]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Sounds with harmonic spectra are more effective than pure tones in inducing audiogenic seizure in rats. [2019]

9. Serbia pubmed.ncbi.nlm.nih.gov

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

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

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

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

Sensory stimulation for inhibition of epileptic seizures. [2019]

12. Poland pubmed.ncbi.nlm.nih.gov

[Usefulness of a strain of mice with genetically determined audiogenic epilepsy as a model of experimental epilepsy]. [2015]