Acoustic Stimulation for Seizure Suppression

N/AActive Not RecruitingNCT03198494

NYU Langone Health36 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Epilepsy

Interventions

Acoustic 1Hz StimulationOTHER

1Hz acoustic pulses delivered during sleep via headphones

Sham Background NoiseOTHER

Background Noise used as a control

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (1)

New York University School of Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 72 hours

Interictal Discharge frequency

IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG

Time frame: 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

Time frame: 2 months

Secondary Outcomes

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.

Time frame: 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).

Time frame: 3 months

Data from ClinicalTrials.gov

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