Auditory Stimulation Effects on Sleep and Memory in Patients With Epilepsy

Epilepsy Clinical Trial

Official title:

Effects of Auditory Stimulation on Coordinated Non-REM Sleep Oscillations and Memory in Epilepsy Inpatients With Implanted Hippocampal Electrodes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04788628
• Other study ID #: 2020P003959
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: March 31, 2026

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Dara Manoach, PhD
• Phone: 617-724-6148
• Email: dara.manoach[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will investigate the role of coordinated brain rhythms during sleep in memory consolidation and determine whether playing precisely timed brief bursts of noise can enhance these rhythms and improve memory in epilepsy inpatients with implanted hippocampal electrodes.

Description:

The investigators will test the hypotheses that coordinated brain rhythms during nonrapid eye movement sleep are associated with memory consolidation and can be enhanced with auditory stimulation (playing precisely timed brief bursts of quiet noise) to improve memory. The investigators will measure differences in sleep and memory performance in epilepsy inpatients with implanted hippocampal electrodes and continuous full scalp EEG monitoring under three overnight sleep conditions: a baseline night; a memory night during which sleep-dependent memory consolidation is assessed with the finger tapping motor sequence task (MST) with training prior to sleep and testing the next morning; and a stimulation night during which participants train on the MST, have precisely timed auditory stimulation during the sleep that follows, and are tested on the MST in the morning.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 31, 2026
• Est. primary completion date: March 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

Inclusion Criteria:

• Inpatients with epilepsy

• Aged 12-65

• Undergoing clinically indicated continuous scalp and intracranial EEG monitoring with implanted hippocampal electrodes

• Fluent in English

• Able to give informed consent/assent (for minors aged 12-17 or adults with an appointed guardian)

Exclusion Criteria:

• Intellectual disability impairing ability to perform task

• Motor problems that preclude finger tapping task

• Previous surgery anticipated to disrupt coordination of sleep oscillations in the circuitry of interest

Related Conditions & MeSH terms

• Epilepsy

Intervention

Other:
• Baseline
Hippocampal and scalp EEG monitoring during overnight sleep
• Motor procedural memory task
Training on the finger tapping MST prior to monitored overnight sleep with MST testing the following morning
• Motor procedural memory task plus auditory stimulation
Training on the finger tapping MST prior to monitored overnight sleep that includes auditory stimulation, with MST testing the following morning

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in slow oscillation-spindle-hippocampal ripple coupling	Changes in the coupling of slow oscillations with spindles and hippocampal ripples during non-Rapid Eye Movement (NREM) sleep as measured by scalp and intracranial EEG between baseline, memory, and auditory stimulation nights.	Three nights of sleep within three weeks
Secondary	Changes in sleep-dependent consolidation of motor procedural memory	Changes in sleep-dependent improvement of motor procedural memory performance on the finger tapping motor sequence task (MST) between baseline, memory, and auditory stimulation nights. Different sequences are employed for the memory and auditory stimulation nights in a counter-balanced order.	Three nights of sleep within three weeks
Secondary	Changes in slow oscillations	Changes in slow oscillations during non-rapid eye movement (NREM) sleep as measured by EEG between the baseline, memory, and auditory stimulation nights	Three nights of sleep within three weeks
Secondary	Changes in sleep spindles	Changes in sleep spindles during non-rapid eye movement (NREM) sleep as measured by EEG between baseline, memory, and auditory stimulation nights	Three nights of sleep within three weeks
Secondary	Changes in hippocampal ripples	Changes in hippocampal ripples during non-rapid eye movement (NREM) sleep as measured by intracranial EEG between baseline, memory, and auditory stimulation nights	Three nights of sleep within three weeks