Threat Reversal Abnormality in Patients With Anxiety Disorders

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.

Conditions

• Anxiety Disorder
• Anxiety State

Interventions

DEVICE

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

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.

Sponsors & Collaborators

• The National Natural Science Foundation of China (NSFC)

  collaborator UNKNOWN

• Shenzhen Kangning Hospital

  lead OTHER

Principal Investigators

• Jingchu Hu, Dr. · Shenzhen Kangning Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-31

Primary Completion

2025-09-30

Completion

2025-09-30