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Clinical Trials/NCT04788628
NCT04788628
Enrolling by Invitation
N/A

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

Massachusetts General Hospital1 site in 1 country24 target enrollmentJanuary 21, 2021
ConditionsEpilepsy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Epilepsy
Sponsor
Massachusetts General Hospital
Enrollment
24
Locations
1
Primary Endpoint
Changes in slow oscillation-spindle-hippocampal ripple coupling
Status
Enrolling by Invitation
Last Updated
5 months ago

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
January 21, 2021
End Date
March 31, 2026
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dara S. Manoach, PhD

Professor

Massachusetts General Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in slow oscillation-spindle-hippocampal ripple coupling

Time Frame: Three nights of sleep within three weeks

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.

Secondary Outcomes

  • Changes in slow oscillations(Three nights of sleep within three weeks)
  • Changes in hippocampal ripples(Three nights of sleep within three weeks)
  • Changes in sleep-dependent consolidation of motor procedural memory(Three nights of sleep within three weeks)
  • Changes in sleep spindles(Three nights of sleep within three weeks)

Study Sites (1)

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