NCT05150951

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 6, 2021

Completed
9 days until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

6 months

First QC Date

November 6, 2021

Last Update Submit

June 9, 2022

Conditions

Keywords

Threat conditioningVirtual realityExtinctionBehavioral tagging

Outcome Measures

Primary Outcomes (1)

  • Physiological arousal response during reinstatement.

    Startle responses and skin conductance responses are used as measures of physiological arousal response.

    Day 3

Secondary Outcomes (4)

  • Physiological arousal response during extinction

    Day 2

  • Physiological arousal response during threat conditioning

    Day 1

  • Subjective fear ratings

    Day 1, 2 & 3.

  • Subjective discomfort ratings

    Day 1, 2 & 3

Other Outcomes (4)

  • Navigation success

    Day 2

  • State-Trait Anxiety Inventory (STAI-T)

    Day 2

  • Generalized anxiety disorder 7 (GAD-7)

    Day 2

  • +1 more other outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Novel exploration is used before extinction in an attempt to strengthen the extinction consolidation.

Behavioral: Novel ExplorationBehavioral: Threat conditioningBehavioral: ExtinctionBehavioral: Reinstatement

Control group

EXPERIMENTAL

Participants perform a control task (visual attention) instead of the novel exploration.

Behavioral: Threat conditioningBehavioral: ExtinctionBehavioral: ReinstatementBehavioral: Visual attention control task

Interventions

Exploration of a novel 3D-environment in virtual reality.

Experimental group

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.

Control groupExperimental group
ExtinctionBEHAVIORAL

Session 2. Participants are repeatedly exposed to the both contexts from session 1 (CS+, CS-), but no shocks are delivered.

Control groupExperimental group
ReinstatementBEHAVIORAL

Session 3. Participants are again repeatedly exposed to both contexts from session 1 (CS+, CS-), after a few shocks delivered in a neutral context.

Control groupExperimental group

Session 2. A visual attention task used as a control task instead of novel exploration.

Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Willing and able to provide informed consent and complete study procedures

You may not qualify if:

  • Current psychiatric disorder.
  • Current use of psychotropic medication
  • Current use of neurological conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University, deparmtent of Psychology

Uppsala, 75142, Sweden

Location

Related Publications (1)

  • Moncada D, Ballarini F, Viola H. Behavioral Tagging: A Translation of the Synaptic Tagging and Capture Hypothesis. Neural Plast. 2015;2015:650780. doi: 10.1155/2015/650780. Epub 2015 Aug 25.

    PMID: 26380117BACKGROUND

MeSH Terms

Interventions

Extinction, Biological

Intervention Hierarchy (Ancestors)

Biological Phenomena

Study Officials

  • Thomas Ă…gren, PhD

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants are never told which manipulation that is expected to affect the threat memory processes.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2021

First Posted

December 9, 2021

Study Start

November 15, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will share

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).

Shared Documents
SAP, ICF
Time Frame
Data will be available from completion of analysis and publication, and onwards.
Access Criteria
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/)

Locations