Acoustic Stimulation for Seizure Suppression

Not Applicable

• Conditions: Epilepsy
• Interventions: Other: Acoustic 1Hz Stimulation; Other: Sham Background Noise

• Registration Number: NCT03198494
• Lead Sponsor: NYU Langone Health

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-21
• Study First Posted: 2017-06-26
• Study Start: 2017-08-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-06
• Primary Completion: 2024-12-17
• Study Completion: 2024-12-17

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 36

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Acoustic 1Hz Stimulation	Acoustic 1Hz Stimulation	1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.
Sham Background Noise	Sham Background Noise	Background noise applied via headphones and downloadable phone application during sleep every night.

Primary Outcome Measures

Name	Time	Method
Interictal Discharge frequency	72 hours	IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG
Successful System Training	72 hours	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.
System Adherence	2 months	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

Secondary Outcome Measures

Name	Time	Method
System Use effect on Features of Sleep	72 hours	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.
Seizure Control	3 months	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).

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States