Acoustic Stimulation for Seizure Suppression

Study Overview
=================
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
-----------------
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. 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. To determine the feasibility of applying low-frequency acoustic stimulation in a long-term home setting in adult epilepsy patients with frequent nocturnal seizures.

Official Title
-----------------
Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Other: Acoustic 1Hz Stimulation
* Other: Sham Background Noise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acoustic 1Hz Stimulation<br>1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night. | Other: Acoustic 1Hz Stimulation<br>* 1Hz acoustic pulses delivered during sleep via headphones<br>|
| Sham Comparator: Sham Background Noise<br>Background noise applied via headphones and downloadable phone application during sleep every night. | Other: Sham Background Noise<br>* Background Noise used as a control<br>|
| No Intervention: Baseline Seizure Monitoring<br>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 |