- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07559656
Oxytocin's Effects on Real Time-fMRI Neurofeedback Training of Anterior Insula Activity
Effects of Intransal Oxytocin on Real-time fMRI Neurofeedback Training of Anterior Insula Activity Using an Interoceptive Strategy
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
A randomized, double-blind, placebo-controlled between-subject design is employed in this study. A total of 80 healthy male participants are recruited and randomly assigned to two groups (oxytocin-OT vs. placebo-PLC). Participants self-administer either intranasal spray of oxytocin or placebo (24 IU). Both groups receive continuous real-time neurofeedback from the left anterior insula. Comparisons between the two groups are conducted to determine whether OT facilitates the neurofeedback effects.
The neurofeedback training task consists of 4 training sessions with real-time feedback and 1 transfer session without feedback. Each session comprises 5 regulation blocks and 5 rest blocks. At the end of each block, participants are presented with pain-related images and asked to rate their level of pain empathy, which was used to determine the effects of neurofeedback training at the behavioral level. A heartbeat detection task is performed pre- and post-training to measure interoceptive accuracy changes induced by neurofeedback training. A functional localizer task (heartbeat counting task) before training was used to localise the anterior insula. Neurofeedback training effects at the neural level were measured by anterior insula activity during training. Personality traits of subjects are assessed using validated Chinese version questionnaires, including the Toronto Alexithymia Scale (TAS), Multidimensional Assessment of Interoceptive Awareness (MAIA), Bermond-Vorst Alexithymia Questionnaire (BVAQ), Interoceptive Confusion Questionnaire (ICQ), Beck Depression Inventory (BDI), State-Trait Anxiety Inventory (STAI), Autism Spectrum Quotient (ASQ), Interpersonal Reactivity Index (IRI), and Cognitive Flexibility Inventory (CFI). Participants are required to complete the Positive and Negative Affect Schedule (PANAS) once each before OT treatment, after OT treatment (before the neurofeedback training task), and after the neurofeedback training task to measure mood changes.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Shuxia Yao, Dr
- Telefonnummer: 18111297596
- E-mail: yaoshuxia@uestc.edu.cn
Studiesteder
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 611731
- Rekruttering
- University of Electronic Science and Technology of China
-
Kontakt:
- Shuxia Yao, Dr
- Telefonnummer: 18111297596
- E-mail: yaoshuxia@uestc.edu.cn
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Healthy subjects without any past or present psychiatric or neurological disorders.
Exclusion Criteria:
- History of brain injury medical or mental illness.
- Contraindication to MRI scanning (e.g., metal implants, claustrophobia or other --conditions that make them inappropriate for MRI scanning).
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Oxytocin
A single dose of 24 international units of oxytocin will be administered with 3 puffs of treatment to each nostril.
|
Each subject will be assigned to intranasally administered 24-IU of oxytocin.
|
|
Placebo komparator: Placebo
A single dose of 24 international units of placebo will be administered with 3 puffs of treatment to each nostril.
|
Each subject will be assigned to intranasally administered 24-IU of placebo.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Neural aktivitet i den anteriore insula baseret på blodiltniveau-afhængige (BOLD) signaler
Tidsramme: 1 time
|
Den anteriore insula-aktivitet, der blev induceret i løbet af reguleringsblokken sammenlignet med baseline-blokken.
|
1 time
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Interoceptiv nøjagtighed
Tidsramme: 10 minutter
|
1/N Σ(1-(|faktiske hjerteslag--rapporterede hjerteslag|) / faktiske hjerteslag).
N angiver antallet af optagelsesblokke.
|
10 minutter
|
|
Pain empathy rating scores
Tidsramme: 1 hour
|
Subjects are required to rate their empathic feelings towards painful pictures on a Likert Scale ranging from 1-9 (1 = not at all and 9 = very painful) after each regulation/baseline block.
|
1 hour
|
|
Confidence rating scores of interoceptive sensitivity
Tidsramme: 1 hour
|
Subjects are asked to rate to what extent they can feel their heartbeat using a Likert Scale ranging from 1-9 (1 = very low and 9 = very high).
|
1 hour
|
|
Functional connectivity of the anterior insula
Tidsramme: 1 hour
|
Differences of functional connectivity of the anterior insula during neurofeedback training
|
1 hour
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- UESTC-neuSCAN-108
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Intranasal oxytocin
-
University of Electronic Science and Technology...RekrutteringSunde deltagereKina
-
Elizabeth Austen LawsonUnited States Department of Defense; University of VirginiaRekrutteringAutismespektrumforstyrrelse | KnoglesundhedForenede Stater
-
University of Electronic Science and Technology...Afsluttet
-
University of NebraskaNational Institute of Mental Health (NIMH)Afsluttet
-
University of Electronic Science and Technology...Afsluttet
-
University of Electronic Science and Technology...Afsluttet
-
University of Electronic Science and Technology...Ukendt
-
Icahn School of Medicine at Mount SinaiSuspenderetBorderline personlighedsforstyrrelseForenede Stater
-
University of Electronic Science and Technology...Afsluttet
-
University of Electronic Science and Technology...Ukendt