- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05150951
An Attempt at Translating Novelty-enhanced Extinction of Context Conditioning From Rodents to Humans
9 juni 2022 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Uppsala, Sverige, 75142
- Uppsala University, deparmtent of Psychology
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 50 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Experimentell: Control group
Participants perform a control task (visual attention) instead of the novel exploration.
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Physiological arousal response during reinstatement.
Tidsram: Day 3
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Startle responses and skin conductance responses are used as measures of physiological arousal response.
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Day 3
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Physiological arousal response during extinction
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Navigation success
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Thomas Ågren, PhD, Uppsala University
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 november 2021
Primärt slutförande (Faktisk)
1 maj 2022
Avslutad studie (Faktisk)
1 maj 2022
Studieregistreringsdatum
Först inskickad
6 november 2021
Först inskickad som uppfyllde QC-kriterierna
26 november 2021
Första postat (Faktisk)
9 december 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 juni 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
9 juni 2022
Senast verifierad
1 juni 2022
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 2021-03596
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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).
Tidsram för IPD-delning
Data will be available from completion of analysis and publication, and onwards.
Kriterier för IPD Sharing Access
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-delning som stöder informationstyp
- SAV
- ICF
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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