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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Shuxia Yao, Dr
- Telefonnummer: 18111297596
- E-post: yaoshuxia@uestc.edu.cn
Studiesteder
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Sichuan
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Chengdu, Sichuan, Kina, 611731
- Rekruttering
- University of Electronic Science and Technology of China
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Ta kontakt med:
- Shuxia Yao, Dr
- Telefonnummer: 18111297596
- E-post: yaoshuxia@uestc.edu.cn
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Oxytocin
A single dose of 24 international units of oxytocin will be administered with 3 puffs of treatment to each nostril.
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Each subject will be assigned to intranasally administered 24-IU of oxytocin.
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Placebo komparator: Placebo
A single dose of 24 international units of placebo will be administered with 3 puffs of treatment to each nostril.
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Each subject will be assigned to intranasally administered 24-IU of placebo.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Neural aktivitet i den anteriore insula basert på blodoksygenavhengig (BOLD) signal
Tidsramme: 1 time
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Den fremre insula-aktiviteten som ble indusert under reguleringsblokken sammenlignet med basislinjeblokken.
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1 time
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Interoceptiv nøyaktighet
Tidsramme: 10 minutter
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1/N Σ(1-(|faktiske hjertebank–rapporterte hjertebank|) / faktiske hjertebank).
N angir antall opptakblokker.
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10 minutter
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Pain empathy rating scores
Tidsramme: 1 hour
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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.
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1 hour
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Confidence rating scores of interoceptive sensitivity
Tidsramme: 1 hour
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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).
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1 hour
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Functional connectivity of the anterior insula
Tidsramme: 1 hour
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Differences of functional connectivity of the anterior insula during neurofeedback training
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1 hour
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
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
Andre studie-ID-numre
- UESTC-neuSCAN-108
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