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Enrolling by invitation NCT04788628

Auditory Stimulation Effects on Sleep and Memory in Patients With Epilepsy

No phase Interventional Epilepsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Baseline, Motor procedural memory task, Motor procedural memory task plus auditory stimulation.
Who it may be relevant to
Registry conditions: Epilepsy. Basic parameters: 12 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Changes in slow oscillation-spindle-hippocampal ripple coupling [Time frame: Three nights of sleep within three weeks]
Secondary outcome measures (4)
  • Changes in sleep-dependent consolidation of motor procedural memory [Time frame: Three nights of sleep within three weeks]
  • Changes in slow oscillations [Time frame: Three nights of sleep within three weeks]
  • Changes in sleep spindles [Time frame: Three nights of sleep within three weeks]
  • Changes in hippocampal ripples [Time frame: Three nights of sleep within three weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Massachusetts General Hospital — Boston

Identifiers

NCT: NCT04788628 · 2020P003959

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗