Anxiety DisorderNCT06232369
Threat Reversal Abnormality in Patients With Anxiety Disorders
A study testing Active repetitive deep transcranial magnetic stimulation (dTMS) in people with Anxiety Disorder and Anxiety State, run by Shenzhen Kangning Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorder, Anxiety State
- What is being tested?
- Active repetitive deep transcranial magnetic stimulation (dTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Sep 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of anxiety disorders (by psychiatrists using the structured clinical interview for DSM-IV-TR (SCID) with reference to the diagnostic criteria for GAD according to the ICD-10)
- No physical diseases or mental disorders.
- No claustrophobia.
- No hereditary diseases.
- No medication history or smoking history.
- Females not pregnant and not in their menstrual period.
- Normal vision or corrected vision, no smoking, drinking alcohol, or taking medication within 24 hours prior to the experiment.
- No previous participation in similar experiments.
Who cannot join
- A history of serious cardiovascular, cerebrovascular diseases, stroke, or other neurological disorders, a history of gastrointestinal diseases.
- Severe hearing or vision impairments.
- Metallic implants in the body, such as non-removable dentures, stents, metal plates, joint metal replacements, etc.
- Claustrophobia.
- Acute or chronic diseases or infections.
- Pregnancy or breastfeeding.
- Smoking or drinking alcohol within 24 hours before the experiment.
- Previous participation in similar experiments conducted by this institution.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Research on Threat Reversal Abnormality and Underlying Neural Mechanisms in Patients With Anxiety Disorders
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:
- 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.
- The neural mechanism underlying threat reversal abnormalities in patients with anxiety disorders is hypothesized to involve the prefrontal cortex, amygdala, and hippocampus.
- The repetitive stimulation to the core brain regions of threat reversal is assumed to improve threat reversal abilities and anxiety symptoms of patients.
Read the 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.
- Conditions
- Anxiety Disorder, Anxiety State
- Being tested
- Active repetitive deep transcranial magnetic stimulation (dTMS), Sham repetitive deep transcranial magnetic stimulation (dTMS)
- Keywords
- Threat Reversal, Emotion Flexibility
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active repetitive deep transcranial magnetic stimulation (dTMS)Device
Before the intervention, the brain structure of each participant will be captured using an MRI scanner, and individualized spatial coordinates of the hypothesized target will be determined based on these 3D structural images. Then the resting motor threshold will be tested using the method of thumb twitching observation.
The intervention will employ the H7 coil that is accurately delivered to the intended target by an optic navigation and a deep pulse protocol at 90% of the tested threshold for 15-minute stimulation duration.
Sham repetitive deep transcranial magnetic stimulation (dTMS)Device
Before the intervention, the brain structure of each participant will be captured using an MRI scanner, and individualized spatial coordinates of the hypothesized target will be determined based on these 3D structural images. Then the resting motor threshold will be tested using the method of thumb twitching observation.
The intervention will employ the H7 coil that is placed on the scalp to mimic the sensation and sounds of the actual treatment but without letting the magnetic field reach the brain tissue for 15-minute duration.
| Study group | Role | What they receive |
|---|---|---|
| Patient group + active stimulation intervention | Experimental | Patient participants with anxiety disorders in this arm will first accept active repetitive stimulation on core brain regions and then complete the threat reversal learning paradigm. Receives: Device: Active repetitive deep transcranial magnetic stimulation (dTMS) |
| Patient group + sham stimulation intervention | Sham comparator | Patient participants with anxiety disorders in this arm will first accept sham repetitive stimulation on core brain regions and then complete the threat reversal learning paradigm. Receives: Device: Sham repetitive deep transcranial magnetic stimulation (dTMS) |
| Healthy control group + sham stimulation intervention | Sham comparator | Healthy participants in this arm will first accept sham repetitive stimulation on core brain regions and then complete the threat reversal learning paradigm. Receives: Device: Sham repetitive deep transcranial magnetic stimulation (dTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in participants' skin conductance response (SCR)
The level of SCR will be assessed for each experiment trial as the base-to-peak amplitude difference in skin conductance of the largest deflection (in micro-siemens; pS) in the 0.5-4.5-slatency window after stimulus onset.
Measured: Baseline; every week (assessed weekly up to 8 weeks from the date of last intervention session)
Changes in the prefrontal cortex measured with fMRI
Changes in the difference in blood oxygenation level dependent (BOLD) signals in the prefrontal cortex before and after the intervention.
Measured: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session)
Changes in the amygdala measured with fMRI
Changes in the difference in blood oxygenation level dependent (BOLD) signals in the amygdala before and after the intervention.
Measured: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session)
Changes in the hippocampus measured with fMRI
Changes in the difference in blood oxygenation level dependent (BOLD) signals in the hippocampus before and after the intervention.
Measured: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session)
Secondary outcomes (3)
Changes in the State-Trait Anxiety Scale (STAI)
The STAI assesses the current state of anxiety and relatively stable aspects of anxiety proneness, each subscale consisting of 20 items. Each item is rated on a 4-point Likert scale, ranging from "Not at all" to "Very much". Higher summed scores in subscales indicate greater state anxiety and trait anxiety.
Measured: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session); 3 months (assessed at the week after 3 months from the last intervention session)
Changes in the Intolerance of Uncertainty Scale-12 (IUS-12)
The IUS measures individuals' emotional, cognitive, and behavioral responses or tolerance to uncertain situations, consisting 12 items. Each item is rated on a 5-point Likert scale, ranging from "Not at all characteristic of me" to "Entirely characteristic of me". Higher summed total scores suggest a higher level of intolerance of uncertainty.
Measured: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session); 3 months (assessed at the week after 3 months from the last intervention session)
Changes in the Anxiety Sensitivity Index (ASI)
The ASI measures the extent to which individuals are sensitive to their own anxiety symptoms, consisting 12 items. Each item is rated on a 5-point Likert scale, ranging from "Not at all characteristic of me" to "Entirely characteristic of me". Higher summed total scores indicate greater anxiety sensitivity.
Measured: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session); 3 months (assessed at the week after 3 months from the last intervention session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study startMar 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangning Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Jingchu Hu, Shenzhen Kangning Hospital
- Investigators
- Jingchu Hu, Dr., Principal investigator, Shenzhen Kangning Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232369
- Sponsor's protocol ID
- 82201672
- Status last verified
- Feb 2024
- First submitted
- 10 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will share our data on the Open Science Framework after data collection
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Threat Reversal Abnormality and Underlying Neural Mechanisms in Patients With Anxiety Disorders
- ClinicalTrials.gov ID
- NCT06232369
- Acronym / sponsor ID
- 82201672
- Conditions
- Anxiety Disorder, Anxiety State
- Keywords
- Threat Reversal, Emotion Flexibility
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Shenzhen Kangning HospitalUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Mar 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 30 Jan 2024 (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.
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:
- 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.
- The neural mechanism underlying threat reversal abnormalities in patients with anxiety disorders is hypothesized to involve the prefrontal cortex, amygdala, and hippocampus.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient group + active stimulation intervention | Experimental | Device: Active repetitive deep transcranial magnetic stimulation (dTMS)Patient participants with anxiety disorders in this arm will first accept active repetitive stimulation on core brain regions and then complete the threat reversal learning paradigm. |
| Patient group + sham stimulation intervention | Sham comparator | Device: Sham repetitive deep transcranial magnetic stimulation (dTMS)Patient participants with anxiety disorders in this arm will first accept sham repetitive stimulation on core brain regions and then complete the threat reversal learning paradigm. |
| Healthy control group + sham stimulation intervention | Sham comparator | Device: Sham repetitive deep transcranial magnetic stimulation (dTMS)Healthy participants in this arm will first accept sham repetitive stimulation on core brain regions and then complete the threat reversal learning paradigm. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of anxiety disorders (by psychiatrists using the structured clinical interview for DSM-IV-TR (SCID) with reference to the diagnostic criteria for GAD according to the ICD-10)
- No physical diseases or mental disorders.
- No claustrophobia.
- No hereditary diseases.
- No medication history or smoking history.
Key exclusion criteria (8 listed)
- A history of serious cardiovascular, cerebrovascular diseases, stroke, or other neurological disorders, a history of gastrointestinal diseases.
- Severe hearing or vision impairments.
- Metallic implants in the body, such as non-removable dentures, stents, metal plates, joint metal replacements, etc.
- Claustrophobia.
- Acute or chronic diseases or infections.
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 |
|---|---|---|
| Active repetitive deep transcranial magnetic stimulation (dTMS)Before the intervention, the brain structure of each participant will be captured using an MRI scanner, and individualized spatial coordinates of the hypothesized target will be determined based on these 3D structural images. Then the resting motor threshold will be tested using the method of thumb twitching observation. The intervention will employ the H7 coil that is accurately delivered to the intended target by an optic navigation and a deep pulse protocol at 90% of the tested threshold for 15-minute stimulation duration. | Device | Patient group + active stimulation intervention |
| Sham repetitive deep transcranial magnetic stimulation (dTMS)Before the intervention, the brain structure of each participant will be captured using an MRI scanner, and individualized spatial coordinates of the hypothesized target will be determined based on these 3D structural images. Then the resting motor threshold will be tested using the method of thumb twitching observation. The intervention will employ the H7 coil that is placed on the scalp to mimic the sensation and sounds of the actual treatment but without letting the magnetic field reach the brain tissue for 15-minute duration. | Device | Healthy control group + sham stimulation intervention, Patient group + sham stimulation intervention |
Primary outcome
Changes in participants' skin conductance response (SCR)
Time frame: Baseline; every week (assessed weekly up to 8 weeks from the date of last intervention session)
The level of SCR will be assessed for each experiment trial as the base-to-peak amplitude difference in skin conductance of the largest deflection (in micro-siemens; pS) in the 0.5-4.5-slatency window after stimulus onset.
Changes in the prefrontal cortex measured with fMRI
Time frame: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session)
Changes in the difference in blood oxygenation level dependent (BOLD) signals in the prefrontal cortex before and after the intervention.
Changes in the amygdala measured with fMRI
Time frame: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session)
Changes in the difference in blood oxygenation level dependent (BOLD) signals in the amygdala before and after the intervention.
Changes in the hippocampus measured with fMRI
Time frame: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session)
Changes in the difference in blood oxygenation level dependent (BOLD) signals in the hippocampus before and after the intervention.
3 secondary outcomes
Changes in the State-Trait Anxiety Scale (STAI)
Time frame: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session); 3 months (assessed at the week after 3 months from the last intervention session)
Changes in the Intolerance of Uncertainty Scale-12 (IUS-12)
Time frame: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session); 3 months (assessed at the week after 3 months from the last intervention session)
Changes in the Anxiety Sensitivity Index (ASI)
Time frame: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session); 3 months (assessed at the week after 3 months from the last intervention session)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: Yes. We will share our data on the Open Science Framework after data collection
Related trials for Anxiety Disorder
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
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.
Jingchu Hu, Dr. principal investigator
Shenzhen Kangning Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Active repetitive deep transcranial magnetic stimulation (dTMS) in people with Anxiety Disorder and Anxiety State, run by Shenzhen Kangning Hospital.
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 8 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingchu Hu, Dr. ((+86)15603072635, hujingchu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in participants' skin conductance response (SCR) (time frame: Baseline; every week (assessed weekly up to 8 weeks from the date of last intervention session)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.