HealthyNCT05150951
An Attempt at Translating Novelty-enhanced Extinction of Context Conditioning From Rodents to Humans
A study testing Novel Exploration, Threat conditioning and Extinction in people with Healthy, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Novel Exploration, Threat conditioning and Extinction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 15 Nov 2021to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing and able to provide informed consent and complete study procedures
Who cannot join
- Current psychiatric disorder.
- Current use of psychotropic medication
- Current use of neurological conditions
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- Novel Exploration, Threat conditioning, Extinction, Reinstatement, Visual attention control task
- Keywords
- Threat conditioning, Virtual reality, Extinction, Behavioral tagging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel ExplorationBehavioural
Exploration of a novel 3D-environment in virtual reality.
Threat conditioningBehavioural
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.
ExtinctionBehavioural
Session 2. Participants are repeatedly exposed to the both contexts from session 1 (CS+, CS-), but no shocks are delivered.
ReinstatementBehavioural
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 taskBehavioural
Session 2. A visual attention task used as a control task instead of novel exploration.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Novel exploration is used before extinction in an attempt to strengthen the extinction consolidation. Receives: Behavioral: Novel Exploration; Behavioral: Threat conditioning; Behavioral: Extinction; Behavioral: Reinstatement |
| Control group | Experimental | Participants perform a control task (visual attention) instead of the novel exploration. Receives: Behavioral: Threat conditioning; Behavioral: Extinction; Behavioral: Reinstatement; Behavioral: Visual attention control task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological arousal response during reinstatement.
Startle responses and skin conductance responses are used as measures of physiological arousal response.
Measured: Day 3
Secondary outcomes (4)
Physiological arousal response during extinction
Startle responses and skin conductance responses are used as measures of physiological arousal response
Measured: Day 2
Physiological arousal response during threat conditioning
Startle responses and skin conductance responses are used as measures of physiological arousal response
Measured: Day 1
Subjective fear ratings
Subjective ratings of fear (0-100) where 0 is no fear and 100 is worst imaginable fear.
Measured: Day 1, 2 & 3.
Subjective discomfort ratings
Subjective ratings of discomfort where 0 is no discomfort and 100 is worst imaginable discomfort.
Measured: Day 1, 2 & 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start15 Nov 2021
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Ågren, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150951
- Sponsor's protocol ID
- 2021-03596
- Status last verified
- Jun 2022
- First submitted
- 6 Nov 2021
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Publications
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.
PubMed 26380117
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Attempt at Translating Novelty-enhanced Extinction of Context Conditioning From Rodents to Humans
- ClinicalTrials.gov ID
- NCT05150951
- Acronym / sponsor ID
- 2021-03596
- Conditions
- Healthy
- Keywords
- Threat conditioning, Virtual reality, Extinction, Behavioral tagging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Novel Exploration, Behavioral: Threat conditioning, Behavioral: Extinction, Behavioral: ReinstatementNovel exploration is used before extinction in an attempt to strengthen the extinction consolidation. |
| Control group | Experimental | Behavioral: Threat conditioning, Behavioral: Extinction, Behavioral: Reinstatement, Behavioral: Visual attention control taskParticipants perform a control task (visual attention) instead of the novel exploration. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Willing and able to provide informed consent and complete study procedures
Key exclusion criteria (3 listed)
- Current psychiatric disorder.
- Current use of psychotropic medication
- Current use of neurological conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel ExplorationExploration of a novel 3D-environment in virtual reality. | Behavioural | Experimental group |
| Threat conditioningSession 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. | Behavioural | Control group, Experimental group |
| ExtinctionSession 2. Participants are repeatedly exposed to the both contexts from session 1 (CS+, CS-), but no shocks are delivered. | Behavioural | Control group, Experimental group |
| ReinstatementSession 3. Participants are again repeatedly exposed to both contexts from session 1 (CS+, CS-), after a few shocks delivered in a neutral context. | Behavioural | Control group, Experimental group |
| Visual attention control taskSession 2. A visual attention task used as a control task instead of novel exploration. | Behavioural | Control group |
Primary outcome
Physiological arousal response during reinstatement.
Time frame: Day 3
Startle responses and skin conductance responses are used as measures of physiological arousal response.
4 secondary outcomes
Physiological arousal response during extinction
Time frame: Day 2
Physiological arousal response during threat conditioning
Time frame: Day 1
Subjective fear ratings
Time frame: Day 1, 2 & 3.
Subjective discomfort ratings
Time frame: Day 1, 2 & 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Background: PubMed 26380117Moncada 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.
- Individual participant dataSharing planned: Yes. 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).
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Ågren, PhD principal investigator
Uppsala University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Exploration, Threat conditioning and Extinction in people with Healthy, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiological arousal response during reinstatement. (time frame: Day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05150951, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.