Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-30 @ 7:40 AM
Study NCT ID:
NCT06232369
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-06
First Post:
2024-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Threat Reversal Abnormality in Patients With Anxiety Disorders
Sponsor:
Shenzhen Kangning Hospital
Organization:
Study Overview
Official Title:
Research on Threat Reversal Abnormality and Underlying Neural Mechanisms in Patients With Anxiety Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
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:
The goal of this clinical trial is to explore the flexibility of threat control and underlying neural mechanism based on the threat reversal paradigm (a highly validated new paradigm where threat learning and inhibition are required) in patients with anxiety disorders (mainly generalized anxiety disorder). The hypotheses are:
1. Threat reversal abilities are hypothesized to be impaired in patients with anxiety disorders compared to healthy normal subjects, which are assumed to be associated with anxiety symptoms.
2. The neural mechanism underlying threat reversal abnormalities in patients with anxiety disorders is hypothesized to involve the prefrontal cortex, amygdala, and hippocampus.
3. The repetitive stimulation to the core brain regions of threat reversal is assumed to improve threat reversal abilities and anxiety symptoms of patients.
1. Threat reversal abilities are hypothesized to be impaired in patients with anxiety disorders compared to healthy normal subjects, which are assumed to be associated with anxiety symptoms.
2. The neural mechanism underlying threat reversal abnormalities in patients with anxiety disorders is hypothesized to involve the prefrontal cortex, amygdala, and hippocampus.
3. The repetitive stimulation to the core brain regions of threat reversal is assumed to improve threat reversal abilities and anxiety symptoms of patients.
Detailed Description:
In this study, there are three sub-trials in combination with skin conductance response (SCR), functional magnetic resonance imaging (fMRI), and non-invasive neuromodulation techniques to uncover the abnormal threat reversal in anxiety disorder at behavioral and neural levels.
Participants in the first trial will learn the threat of emotional faces based on the Pavlovian conditioned fear learning paradigm; their neural activities in the hypothesized brain regions will be obtained via brain imaging equipment. The researchers will compare the differences among three groups (one patient group, two healthy control groups with different anxiety level) on performance in the threat reversal task, and their neural activities and brain functional connectivity characteristics, in order to reveal the potential behavioral threat reversal abnormalities and core associated brain regions underlying threat reversal.
Participants in the second trial will be given the same learning paradigm and brain imaging equipment as in the first, but with repetitive stimulation intervention on the core brain regions determined in study 1. Using a double-blind randomized controlled experiment, the participants will be divided into three groups (active stimulation + patient, sham stimulation + patient, and sham stimulation + healthy control). The researchers will compare the behavioral differences in the threat reversal task after active and sham stimulation.
Participants in the third trial will be given the same study design and intervention as the second trial, but for eight weeks. Finally, the researchers will retest and compare the improvement in threat reversal abilities and anxiety symptoms to see the long-term clinical effects of the intervention.
Participants in the first trial will learn the threat of emotional faces based on the Pavlovian conditioned fear learning paradigm; their neural activities in the hypothesized brain regions will be obtained via brain imaging equipment. The researchers will compare the differences among three groups (one patient group, two healthy control groups with different anxiety level) on performance in the threat reversal task, and their neural activities and brain functional connectivity characteristics, in order to reveal the potential behavioral threat reversal abnormalities and core associated brain regions underlying threat reversal.
Participants in the second trial will be given the same learning paradigm and brain imaging equipment as in the first, but with repetitive stimulation intervention on the core brain regions determined in study 1. Using a double-blind randomized controlled experiment, the participants will be divided into three groups (active stimulation + patient, sham stimulation + patient, and sham stimulation + healthy control). The researchers will compare the behavioral differences in the threat reversal task after active and sham stimulation.
Participants in the third trial will be given the same study design and intervention as the second trial, but for eight weeks. Finally, the researchers will retest and compare the improvement in threat reversal abilities and anxiety symptoms to see the long-term clinical effects of the intervention.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: