- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05150951
An Attempt at Translating Novelty-enhanced Extinction of Context Conditioning From Rodents to Humans
9. juni 2022 oppdatert av: Uppsala University
In rodents, novel exploration has been used to strengthen the consolidation of a variety of hippocampal-dependent learning tasks.
To our knowledge, no attempt have been made to translate the effect of strengthening the memory of an extinction of a context conditioning memory.
This study uses virtual reality for both context conditioning and novel exploration in an attempt at translating these findings from rodents to humans, thus, using novel exploration to strengthen an extinction memory.
Threat responses are measured with skin conductance and startle responses.
If this effect could be shown experimentally in humans, that experimental setup could become an important tool in understanding important memory processes of fear, such as reconsolidation and behavioral tagging.
Studieoversikt
Status
Fullført
Forhold
Detaljert beskrivelse
The study employs healthy participants and includes three experimental sessions, roughly 24 h apart.
During the first session, participants undergo context conditioning in virtual reality where the CS+ and CS- are two different rooms.
During the second session, half of the participants perform an exploration of a novel virtual environment, and the other half performs a visual attention task.
About 60 min later, participants undergo extinction to the context conditioning performed in session 1, again in virtual reality.
In session 3, remaining threat responses are measured through a reinstatement procedure, again in virtual reality.
Studietype
Intervensjonell
Registrering (Faktiske)
60
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Uppsala, Sverige, 75142
- Uppsala University, deparmtent of Psychology
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 50 år (Voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Willing and able to provide informed consent and complete study procedures
Exclusion Criteria:
- Current psychiatric disorder.
- Current use of psychotropic medication
- Current use of neurological conditions
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Experimental group
Novel exploration is used before extinction in an attempt to strengthen the extinction consolidation.
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Exploration of a novel 3D-environment in virtual reality.
Session 1. Threat conditioning to two different (CS+, CS-) virtual reality contexts (i.e rooms).
One of these is paired with a mild electric shock.
The context paired with the electric shock (CS+) is counterbalanced across participants.
Participants are instructed that they may receive electrical shocks during the procedure.
Session 2. Participants are repeatedly exposed to the both contexts from session 1 (CS+, CS-), but no shocks are delivered.
Session 3. Participants are again repeatedly exposed to both contexts from session 1 (CS+, CS-), after a few shocks delivered in a neutral context.
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Eksperimentell: Control group
Participants perform a control task (visual attention) instead of the novel exploration.
|
Session 1. Threat conditioning to two different (CS+, CS-) virtual reality contexts (i.e rooms).
One of these is paired with a mild electric shock.
The context paired with the electric shock (CS+) is counterbalanced across participants.
Participants are instructed that they may receive electrical shocks during the procedure.
Session 2. Participants are repeatedly exposed to the both contexts from session 1 (CS+, CS-), but no shocks are delivered.
Session 3. Participants are again repeatedly exposed to both contexts from session 1 (CS+, CS-), after a few shocks delivered in a neutral context.
Session 2. A visual attention task used as a control task instead of novel exploration.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Physiological arousal response during reinstatement.
Tidsramme: Day 3
|
Startle responses and skin conductance responses are used as measures of physiological arousal response.
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Day 3
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Physiological arousal response during extinction
Tidsramme: Day 2
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Startle responses and skin conductance responses are used as measures of physiological arousal response
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Day 2
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Physiological arousal response during threat conditioning
Tidsramme: Day 1
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Startle responses and skin conductance responses are used as measures of physiological arousal response
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Day 1
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Subjective fear ratings
Tidsramme: Day 1, 2 & 3.
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Subjective ratings of fear (0-100) where 0 is no fear and 100 is worst imaginable fear.
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Day 1, 2 & 3.
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Subjective discomfort ratings
Tidsramme: Day 1, 2 & 3
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Subjective ratings of discomfort where 0 is no discomfort and 100 is worst imaginable discomfort.
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Day 1, 2 & 3
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Navigation success
Tidsramme: Day 2
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Questions designed to probe the amount of navigation performed by participants doing the novel exploration task.
Three yes/no question of "Did you find object X?" and then participants are asked to point at their position in a stylized map overviewing the novel exploration context.
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Day 2
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State-Trait Anxiety Inventory (STAI-T)
Tidsramme: Day 2
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This is a self-rated questionnaire measuring trait anxiety.
Higher scores indicate higher level of trait-anxiety (range 20-80).
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Day 2
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Generalized anxiety disorder 7 (GAD-7)
Tidsramme: Day 2
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This is a self-rated questionnaire for screening and severity measuring of generalized anxiety disorder (range 0-21).
Higher scores indicate more symptoms of generalized anxiety.
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Day 2
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Patient Health Questionnaire 9 (PHQ-9)
Tidsramme: Day 2
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This is a self-rated questionnaire for screening for the presence and severity of depression (0-27).
Higher scores indicate a more symptoms, and severity of symptoms, of depression
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Day 2
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Thomas Ågren, PhD, Uppsala University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. november 2021
Primær fullføring (Faktiske)
1. mai 2022
Studiet fullført (Faktiske)
1. mai 2022
Datoer for studieregistrering
Først innsendt
6. november 2021
Først innsendt som oppfylte QC-kriteriene
26. november 2021
Først lagt ut (Faktiske)
9. desember 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
10. juni 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juni 2022
Sist bekreftet
1. juni 2022
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2021-03596
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
We plan to share anonymous behavioural data, training material, Statistical Analysis plan, and informed consent form on the project site on Open Science Framework (https://osf.io/4yjev/).
Statistical Analysis Plan will be pre-registered on the same site (Open Science Framework).
IPD-delingstidsramme
Data will be available from completion of analysis and publication, and onwards.
Tilgangskriterier for IPD-deling
Anonymous behavioural data, training material, Statistical Analysis plan, and informed consent form will be made public on the project site on Open Science Framework (https://osf.io/4yjev/)
IPD-deling Støtteinformasjonstype
- SEVJE
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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