Acoustic Stimulation for Seizure Suppression

NYU Langone Health

Status: Invitation-only

Conditions: Epilepsy

Treatments: Other: Acoustic 1Hz Stimulation; Other: Sham Background Noise

Study type: Interventional

Funder types: Other

Identifiers

NCT03198494

17-00698

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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36 participants in 3 patient groups

Acoustic 1Hz Stimulation

Experimental group

Description:

1 Hz acoustic stimulation applied via headphones and downloadable phone application during sleep every night.

Treatment:

Other: Acoustic 1Hz Stimulation

Sham Background Noise

Sham Comparator group

Description:

Background noise applied via headphones and downloadable phone application during sleep every night.

Treatment:

Other: Sham Background Noise

Baseline Seizure Monitoring

No Intervention group

Description:

No use of sound system; Patients record seizures in a diary.