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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05150951
Other study ID # 2021-03596
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 15, 2021
Est. completion date May 1, 2022

Study information

Verified date June 2022
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 1, 2022
Est. primary completion date May 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Novel Exploration
Exploration of a novel 3D-environment in virtual reality.
Threat conditioning
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.
Extinction
Session 2. Participants are repeatedly exposed to the both contexts from session 1 (CS+, CS-), but no shocks are delivered.
Reinstatement
Session 3. Participants are again repeatedly exposed to both contexts from session 1 (CS+, CS-), after a few shocks delivered in a neutral context.
Visual attention control task
Session 2. A visual attention task used as a control task instead of novel exploration.

Locations

Country Name City State
Sweden Uppsala University, deparmtent of Psychology Uppsala

Sponsors (1)

Lead Sponsor Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

References & 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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Navigation success 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. Day 2
Other State-Trait Anxiety Inventory (STAI-T) This is a self-rated questionnaire measuring trait anxiety. Higher scores indicate higher level of trait-anxiety (range 20-80). Day 2
Other Generalized anxiety disorder 7 (GAD-7) 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. Day 2
Other Patient Health Questionnaire 9 (PHQ-9) 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 Day 2
Primary Physiological arousal response during reinstatement. Startle responses and skin conductance responses are used as measures of physiological arousal response. Day 3
Secondary Physiological arousal response during extinction Startle responses and skin conductance responses are used as measures of physiological arousal response Day 2
Secondary Physiological arousal response during threat conditioning Startle responses and skin conductance responses are used as measures of physiological arousal response Day 1
Secondary Subjective fear ratings Subjective ratings of fear (0-100) where 0 is no fear and 100 is worst imaginable fear. Day 1, 2 & 3.
Secondary Subjective discomfort ratings Subjective ratings of discomfort where 0 is no discomfort and 100 is worst imaginable discomfort. Day 1, 2 & 3
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