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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether low-frequency sounds can reduce nighttime seizures in people with epilepsy. Participants will either receive sound therapy (Acoustic 1Hz Stimulation) through headphones while they sleep, listen to background noise (Sham Background Noise), or maintain a seizure diary without using the sound system. The goal is to determine if this daily, at-home therapy can manage nocturnal seizures over the long term. This trial may suit adults who frequently experience nighttime seizures and can sleep with headphones on. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance seizure management.

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 prior data suggests that this protocol is safe for epilepsy patients?

Research shows that 1 Hz sound waves are generally safe and well-tolerated for people with epilepsy. Studies on similar low-frequency treatments, such as 1 Hz deep repetitive transcranial magnetic stimulation (rTMS), have found these methods safe for those with temporal lobe epilepsy. Participants in these studies reported no major side effects, indicating that this type of stimulation is unlikely to cause significant problems. While more research is needed to confirm its effectiveness, current evidence supports the safety of using low-frequency sound waves in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Acoustic 1Hz Stimulation for epilepsy because it introduces a non-invasive approach to managing seizures through sound therapy during sleep. Unlike traditional epilepsy treatments, which often include medications like antiepileptic drugs or surgical interventions, this method uses low-frequency sound waves to potentially modulate brain activity and reduce seizure frequency. This innovative technique could offer a new option for patients looking for alternatives to medication, with the added convenience of being applied via a phone app and headphones, making it easy to integrate into daily life.

What evidence suggests that this protocol is effective for epilepsy?

Research has shown that low-frequency sound waves (1 Hz), which participants in this trial may receive as part of the Acoustic 1Hz Stimulation arm, might help reduce seizures in people with epilepsy. Studies have found that similar low-frequency methods can calm the brain and decrease seizure activity. For example, treatments like repetitive magnetic stimulation successfully reduced seizures by up to 50%. Although this specific sound-based approach is still under investigation, early results are promising for controlling seizures during sleep. ^{2 5 6 7 8}

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.

I have been diagnosed with a sleep disorder.

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38490472/

Systematic 1 Hz direct electrical stimulation for seizure ... Fifty-six percent (23/41) of patients undergoing 1 Hz stimulation had seizures induced, 83% (19/23) habitual (clinically and electrographically) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1059131125001876

A crossover, randomized, single-blinded, sham-controlled ... Active rTMS showed a 50 % responder rate and 16.7 % seizure freedom compared to sham stimulation. •. Seizure reduction was most prominent in the first two weeks ...

3. clinicaltrial.be clinicaltrial.be/en/details/177559?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Acoustic Stimulation for Seizure Suppression - Clinical T... To determine the acute physiological effects of low-frequency acoustic stimulation on interictal epileptiform discharge (IED) frequency during ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9092568/

Preliminary Report of the Safety and Tolerability of 1 Hz ... Low frequency (≤1 Hz) repetitive transcranial magnetic stimulation (rTMS) has been shown to suppress cortical excitability and is beginning to ...

5. nature.com nature.com/articles/s41598-023-43975-1

A comprehensive study on the efficacy of a wearable sleep ... This paper aims to enhance the efficacy of such an intervention by proposing a novel sleep aid system that can sense multiple physiological signals ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35572122/

Preliminary Report of the Safety and Tolerability of 1 Hz ... The current pilot study was aimed to test the tolerability and safety of temporal lobe rTMS using H-coil for the treatment of temporal lobe epilepsy (TLE).

7. aesnet.org aesnet.org/abstractslisting/safety-and-tolerability-of-1-hz-deep-repetitive-transcranial-magnetic-stimulation-(rtms)-for-treatment-of-temporal-lobe-epilepsy

SAFETY-AND-TOLERABILITY-OF-1-HZ-DEEP-REPETITIVE ... Conclusions: 1 Hz deep rTMS appears safe and well-tolerated in patients with TLE. While too early for definitive analysis of efficacy, the ...

8. nature.com nature.com/articles/s41598-022-25864-1

Safety of transcutaneous auricular vagus nerve stimulation ... This is the first systematic review and meta-analysis of transcutaneous auricular stimulation safety. Overall, taVNS is a safe and feasible option for clinical ...