Ignite Creation Date:
2024-05-06 @ 3:59 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02423044
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2015-04-18
Brief Title:
Spatial Context and Fear Learning
Sponsor:
National Institute of Mental Health NIMH
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
fMRI Spatial Context and Fear Conditioning
Status:
COMPLETED
Status Verified Date:
2018-10-30
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- Fear is a normal response to a threat Learning fear can be helpful sometimes For people with anxiety disorders fear can be long-lasting and too intense Researchers want to study how people become fearful of situations They want to understand how the brain learns when it is helpful to feel fear and when it is not
Objective
- To better understand brain processes related to fear and anxiety
Eligibility
Right-handed adults ages 18 50 with generalized anxiety disorder panic disorder social anxiety disorder or post-traumatic stress disorder
Right handed volunteers ages 18-50 without psychiatric disorders
And free of psychiatric medication for 2 weeks
Design
Participants will first be screened under another protocol
Participants will play a video game inside a magnetic resonance imaging MRI scanner The scanner is a metal cylinder It is surrounded by a strong magnetic field Participants will lie on a table that can slide in and out of the scanner A device called a coil will be placed over the head
During the scan participants may play a virtual reality video game Game instructions will be explained before they enter the scanner
While playing the game participants will wear 2 electrodes on their fingers These measure sweat on the skin They will also have 2 small electrodes attached to the left hand These can give brief mild electrical shocks
Participants will be asked questions when playing the game during the scan
Before and after the scan participants will fill out questionnaires about their emotions They may complete questionnaires online while at the clinic
- Fear is a normal response to a threat Learning fear can be helpful sometimes For people with anxiety disorders fear can be long-lasting and too intense Researchers want to study how people become fearful of situations They want to understand how the brain learns when it is helpful to feel fear and when it is not
Objective
- To better understand brain processes related to fear and anxiety
Eligibility
Right-handed adults ages 18 50 with generalized anxiety disorder panic disorder social anxiety disorder or post-traumatic stress disorder
Right handed volunteers ages 18-50 without psychiatric disorders
And free of psychiatric medication for 2 weeks
Design
Participants will first be screened under another protocol
Participants will play a video game inside a magnetic resonance imaging MRI scanner The scanner is a metal cylinder It is surrounded by a strong magnetic field Participants will lie on a table that can slide in and out of the scanner A device called a coil will be placed over the head
During the scan participants may play a virtual reality video game Game instructions will be explained before they enter the scanner
While playing the game participants will wear 2 electrodes on their fingers These measure sweat on the skin They will also have 2 small electrodes attached to the left hand These can give brief mild electrical shocks
Participants will be asked questions when playing the game during the scan
Before and after the scan participants will fill out questionnaires about their emotions They may complete questionnaires online while at the clinic
Detailed Description:
Objective
To examine the processes involved in distinguishing between threatening and safe conditions we aim to investigate the neural bases of contextual fear learning using functional magnetic resonance imaging fMRI To do this we will study behavioral physiological and brain responses as aversive stimuli are encountered in a virtual environment and will explore how fear-related responses depend on the surrounding environment In addition we will examine how these responses differ in clinical anxiety
We are interested in studying Pavlovian aversive context conditioning in healthy controls and patients with anxiety disorders We will examine the extent to which participants learn to discriminate between dangerous and safe virtual contexts and how this learning maps to the neural networks underlying anxiety and context coding We expect successful learning of the contextual fear response in healthy controls as evidenced by differential skin conductance response and neural activation to safe vs threat context Accordingly we anticipate higher neuronal activity in the hippocampus prefrontal cortex and amygdala These findings will be accompanied with increased hippocampus-prefrontal cortex connectivity during approach and exploration of the dangerous context and increased amygdala activation during anticipation of shock in the dangerous context Physiologically SCR will increase in threat context compared to safe context However anxious patients are expected to fail to learn to differentiate safe from threat context exhibiting increased SCR and neural activation in both safe and threat contexts an index of contextual generalization of fear Particularly the lack of contextual fear discrimination in anxious patients will be associated with weaker hippocampal activation to contextual learning To examine differential context fear conditioning we will use a virtual reality VR paradigm VR provides an optimal way to probe spatial navigation and simulates context The VR task presents an outdoor space which comprises a dangerous probabilistic electrical shocks and a safe no shocks location Healthy controls and patients with anxiety disorders will be compared on their physiological and neural reactivity during task performance Preliminary psychophysiological data suggest that the proposed procedure is an effective way to promote different responses to a safe and dangerous spatial location Hence we anticipate that this procedure will allow us to examine brain correlates of differential contextual fear responses in humans and compare them between healthy participants and patients diagnosed with an anxiety disorder
Study population
Two study populations healthy volunteers and patients diagnosed with an anxiety disorder generalized anxiety disorder GAD social anxiety disorder SAD panic disorder and post-traumatic stress disorder will complete the protocol Participants will be adult males and females aged 18 to 50 years
Design
This fMRI study will compare performance physiological and neural measures between healthy adults and patients with anxiety disorders who perform a threat VR task in the scanner
The VR task entails navigating in a virtual outdoor environment which unbeknownst to the participants is divided into a safe and a dangerous context which are recognizable by environmental characteristics eg mountain clouds The dangerous context is associated with probabilistic shocks which are never encountered in the safe context Participants learn about these two contexts as they collect flowers cues one at a time in either context In the dangerous context the flowers are associated with 50 chance of a shock
Outcome measures
The primary outcome measures will be the cerebral fMRI blood-oxygen-level dependent BOLD responses to three events 1 shock anticipation after collecting the cues flowers during anticipation of a potential shock 2 context exploration as participants navigate in the threat context or safe context in between trials which start when a flower appears in the environment and 3 cue approach during approach towards the flower in the threat or safe context The secondary outcome measures will consist of the changes in psychophysiological responses such as SCR heart rate pupil dilatation and respiratory rate which will validate fear responses
To examine the processes involved in distinguishing between threatening and safe conditions we aim to investigate the neural bases of contextual fear learning using functional magnetic resonance imaging fMRI To do this we will study behavioral physiological and brain responses as aversive stimuli are encountered in a virtual environment and will explore how fear-related responses depend on the surrounding environment In addition we will examine how these responses differ in clinical anxiety
We are interested in studying Pavlovian aversive context conditioning in healthy controls and patients with anxiety disorders We will examine the extent to which participants learn to discriminate between dangerous and safe virtual contexts and how this learning maps to the neural networks underlying anxiety and context coding We expect successful learning of the contextual fear response in healthy controls as evidenced by differential skin conductance response and neural activation to safe vs threat context Accordingly we anticipate higher neuronal activity in the hippocampus prefrontal cortex and amygdala These findings will be accompanied with increased hippocampus-prefrontal cortex connectivity during approach and exploration of the dangerous context and increased amygdala activation during anticipation of shock in the dangerous context Physiologically SCR will increase in threat context compared to safe context However anxious patients are expected to fail to learn to differentiate safe from threat context exhibiting increased SCR and neural activation in both safe and threat contexts an index of contextual generalization of fear Particularly the lack of contextual fear discrimination in anxious patients will be associated with weaker hippocampal activation to contextual learning To examine differential context fear conditioning we will use a virtual reality VR paradigm VR provides an optimal way to probe spatial navigation and simulates context The VR task presents an outdoor space which comprises a dangerous probabilistic electrical shocks and a safe no shocks location Healthy controls and patients with anxiety disorders will be compared on their physiological and neural reactivity during task performance Preliminary psychophysiological data suggest that the proposed procedure is an effective way to promote different responses to a safe and dangerous spatial location Hence we anticipate that this procedure will allow us to examine brain correlates of differential contextual fear responses in humans and compare them between healthy participants and patients diagnosed with an anxiety disorder
Study population
Two study populations healthy volunteers and patients diagnosed with an anxiety disorder generalized anxiety disorder GAD social anxiety disorder SAD panic disorder and post-traumatic stress disorder will complete the protocol Participants will be adult males and females aged 18 to 50 years
Design
This fMRI study will compare performance physiological and neural measures between healthy adults and patients with anxiety disorders who perform a threat VR task in the scanner
The VR task entails navigating in a virtual outdoor environment which unbeknownst to the participants is divided into a safe and a dangerous context which are recognizable by environmental characteristics eg mountain clouds The dangerous context is associated with probabilistic shocks which are never encountered in the safe context Participants learn about these two contexts as they collect flowers cues one at a time in either context In the dangerous context the flowers are associated with 50 chance of a shock
Outcome measures
The primary outcome measures will be the cerebral fMRI blood-oxygen-level dependent BOLD responses to three events 1 shock anticipation after collecting the cues flowers during anticipation of a potential shock 2 context exploration as participants navigate in the threat context or safe context in between trials which start when a flower appears in the environment and 3 cue approach during approach towards the flower in the threat or safe context The secondary outcome measures will consist of the changes in psychophysiological responses such as SCR heart rate pupil dilatation and respiratory rate which will validate fear responses
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 15-M-0114 | None | None | None |