Acoustic Stimulation for Seizure Suppression

Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression

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

Study Overview

• Status: Active, not recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Other: Acoustic 1Hz Stimulation; Other: Sham Background Noise

Detailed Description

1. To test the feasibility of wearing an earphone system delivering acoustic stimulation during a night of sleep in adult epilepsy patients monitored in an inpatient unit.
2. To determine the acute physiological effects of low-frequency acoustic stimulation on interictal epileptiform discharge (IED) frequency during NREM sleep in adult patients with epilepsy in an ambulatory setting.
3. To determine the feasibility of applying low-frequency acoustic stimulation in a long-term home setting in adult epilepsy patients with frequent nocturnal seizures.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 18-60 years old
• Able to provide informed consent
• MOCA ≥26
• Fluent in English
• Frequent nocturnal IEDs (≥ 10% of the sleep record)
• Monitored on the adult epilepsy monitoring unit (EMU, for Aim 1 only) Additional inclusion criteria for Aim 3
• Frequent nocturnal seizures (≥1 per week)

Exclusion Criteria:

• Hearing impairment
• Diagnosis of a sleep disorder (sleep apnea, periodic limb movements of sleep, or other medical conditions with frequent arousals)
• Psychoactive medication use (other than AEDs, for example SSRIs, antipsychotics, BDZ, or stimulants)
• Seizures ≤ 24 hours prior to study.
• Alcohol or recreational drug use in the 24 hours prior to the study
• BMI ≥ 30
• MOCA <26
• History of recent travel across time zones within the 1 month prior to study activities
• Shift work for 1 month prior to study activities Additional Exclusion Criteria for Aim 3
• No medication changes at least 1 month before study, and during 3 months of study activities

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acoustic 1Hz Stimulation; 1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.	Other: Acoustic 1Hz Stimulation; 1Hz acoustic pulses delivered during sleep via headphones
Sham Comparator: Sham Background Noise; Background noise applied via headphones and downloadable phone application during sleep every night.	Other: Sham Background Noise; Background Noise used as a control
No Intervention: Baseline Seizure Monitoring; No use of sound system; Patients record seizures in a diary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful System Training	Assessment of how well participants learn to use stimulation smart-phone application and headphones, defined as the percentage of subjects with correctly maintained earphones during the first four hours of nocturnal sleep in the first days of use.	72 hours
Interictal Discharge frequency	IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG	72 hours
System Adherence	Percentage of nights during which patients were compliant with the acoustic stimulation device during two months of home use (1 month control acoustic condition, 1 month 1Hz stimulation) determined weekly by patient self-report	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
System Use effect on Features of Sleep	Effect of system use on sleep features, including time spent in each stage of sleep, delta and spindle power and spatial distribution gather from EEG.	72 hours
Seizure Control	Seizure frequency during control and treatment months gathered from seizure diary and IED frequency gathered from EEG (1 month baseline, 1 month sham stimulation, 1 month 1Hz stimulation).	3 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Anli Liu, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2017
• Primary Completion (Estimated): November 21, 2028
• Study Completion (Estimated): November 21, 2028

Study Registration Dates

• First Submitted: June 16, 2017
• First Submitted That Met QC Criteria: June 21, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: 17-00698

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No