An interventional study of Active repetitive deep transcranial magnetic stimulation (dTMS) and Sham repetitive deep transcranial magnetic stimulation (dTMS) in Anxiety Disorder and Anxiety State, sponsored by Shenzhen Kangning Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-06.
Sponsored by Shenzhen Kangning Hospital · Not applicable, Interventional, and Treatment
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:
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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 190 is above the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Shenzhen Kangning Hospital is the lead sponsor of 8 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinical diagnosis of anxiety disorders (by psychiatrists using the structured clinical interview for (SCID) with reference to the diagnostic criteria for GAD according to the ICD-10)
Exclusion Criteria for patient participants:
Inclusion Criteria for healthy control participants:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Active 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.
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.
Device: 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 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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; once per week (assessed weekly up to 8 weeks from the date of last intervention session)
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.
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)
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.
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)
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.
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)
No study locations are listed for this record.
Plan to share: Yes — We will share our data on the Open Science Framework after data collection
Supporting information: Study protocol, Statistical analysis plan
Time frame: The information will be shared after the related paper is published and will be available for at least one year.
Access criteria: The information will be shared on the Open Science Framework for the public.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Shenzhen Kangning Hospital