- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04788628
Auditiv stimuleringseffekt på søvn og hukommelse hos pasienter med epilepsi
Effekter av auditiv stimulering på koordinerte ikke-REM søvnoscillasjoner og hukommelse hos epilepsipasienter med implanterte hippocampale elektroder
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
Massachusetts
-
Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Epilepsy inpatients
Epilepsy inpatients with implanted hippocampal electrodes and continuous scalp EEG monitoring |
Hippocampal and scalp EEG monitoring during overnight sleep Training on the finger tapping MST prior to monitored overnight sleep with MST testing the following morning Training on the finger tapping MST prior to monitored overnight sleep that includes auditory stimulation, with MST testing the following morning |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in slow oscillation-spindle-hippocampal ripple coupling
Tidsramme: 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. |
Three nights of sleep within three weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Changes in sleep-dependent consolidation of motor procedural memory
Tidsramme: Three nights of sleep within three weeks
|
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
|
|
Changes in slow oscillations
Tidsramme: Three nights of sleep within three weeks
|
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
|
|
Changes in sleep spindles
Tidsramme: Three nights of sleep within three weeks
|
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
|
|
Changes in hippocampal ripples
Tidsramme: Three nights of sleep within three weeks
|
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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Dara Manoach, PhD, Professor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2020P003959
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
The PI will disseminate results through presentations at public lectures, scientific institutions and meetings, and/or publications in major journals. The institution and the PI will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources. Prevailing standards and guidelines in documenting and depositing data sets will be followed. Specifically, quality-controlled data used in publications will be deidentified and made available to requesting scientists, starting one year following the completion of the project. Workflows will be documented and will allow any external groups to reproduce results from the raw data. The PI will be responsible for overseeing the sharing the data. Raw and summary data will be submitted to the appropriate NIMH Data Archive annually, including The National Database for Clinical Trials Related to Mental Illness (NDCT).
IPD-delingstidsramme
Data will be available one year following the completion of the project.
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