Acoustic Stimulation for Seizure Suppression

Epilepsy Clinical Trial

Official title:

Low Frequency Acoustic Stimulation During Sleep for Seizure Suppression

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03198494
• Other study ID #: 17-00698
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 17, 2017
• Est. completion date: December 17, 2024

Study information

• Verified date: September 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 36
• Est. completion date: December 17, 2024
• Est. primary completion date: December 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

Other:
• Acoustic 1Hz Stimulation
1Hz acoustic pulses delivered during sleep via headphones
• Sham Background Noise
Background Noise used as a control

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Interictal Discharge frequency	IED frequency during nighttime sleep as measured by a 72 hour ambulatory EEG	72 hours
Primary	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	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
Secondary	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