Neuroimage-guided Dual-target Continuous Theta Burst Stimulation for Generalized Anxiety Disorder

Not Applicable

Not yet recruiting

• Conditions: Anxiety; Transcranial Magnetic Stimulation Repetitive

• Registration Number: NCT06699706

Brief Summary

The aim of this clinical trial was to determine whether image-guided dual-target cTBS is effective for anxiety disorders. The main questions it aims to answer are:

1. Does dual-target cTBS improve patients' anxiety symptoms?

2. Does dual-target cTBS improve patients' somatization symptoms?

3. Researchers will compare cTBS real and sham stimulation to determine whether cTBS is effective in treating anxiety disorders.

Participants will:

1. Received either cTBS treatment or sham stimulation for 7 consecutive days

2. Psychological assessment and MRI scan were performed before treatment, within 2 days, 2 weeks and 1 month after treatment

3. Adverse reactions during the experiment were recorded

Detailed Description

This was a randomized, double-blind, sham-controlled clinical trial. Patients with generalized anxiety disorder (GAD) were recruited from the Neurology Outpatient Clinic and Psychiatry Outpatient Clinic at the First Affiliated Hospital of Anhui Medical University, as well as the Psychiatry Outpatient Clinic and Inpatient Ward at the Second Affiliated Hospital of Anhui Medical University. The diagnosis of GAD was based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), independently confirmed by two professional psychiatrists. Patients meeting the inclusion criteria provided written informed consent and were randomly assigned to either a true cTBS treatment group or a sham stimulation group.

The patients, clinical assessors, and all personnel responsible for clinical care remained blinded to group allocation. Only the rTMS operators were aware of the randomization details; they were not involved in clinical assessments or data processing.

After randomization, patients underwent 7 days of cTBS treatment and completed psychological evaluations and multimodal MRI scans at three time points: baseline, post-treatment, and follow-up. Baseline evaluations were conducted within 24 hours before the first cTBS session, while post-treatment and follow-up evaluations were performed 24 hours after the final cTBS session and four weeks later, respectively.

At each time point (baseline, post-treatment, and follow-up), trained evaluators conducted MRI scans and administered the following scales and behavioral paradigms:

Mini-Mental State Examination (MMSE); Verbal Fluency Test (VFT); Hamilton Anxiety Rating Scale (HAMA); Hamilton Depression Rating Scale (HAMD); Patient Health Questionnaire-15 (PHQ-15); Self-Rating Anxiety Scale (SAS); Insomnia Severity Index (ISI); Four-Dimensional Symptom Questionnaire - Somatization Subscale (4DSQSom); Anxiety Sensitivity Index (ASI); Spielberger State-Trait Anxiety Inventory (STAI); Fear of Pain Questionnaire (FPQ); Ruminative Responses Scale (RRS); Intolerance of Uncertainty Scale (IUS-12); Penn State Worry Questionnaire (PSWQ); Multidimensional Assessment of Interoceptive Awareness (MAIA-2); Short Suggestibility Scale (SSS); MFTM-A (Cognitive Control Capacity); Attention Network Test (ANT); N-back Task (Working Memory); Threshold and Subliminal Stimuli Paradigm.

These scales and paradigms were used to assess the severity of symptoms across different dimensions of anxiety. Additionally, demographic data, structural MRI (sMRI), and functional MRI (fMRI) data were collected at baseline. The sMRI data were utilized for real-time navigation during stimulation.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-19
• Last Update Submitted: 2024-11-19
• Study First Posted: 2024-11-21
• Last Update Posted: 2024-11-21
• Study Start: 2024-11-30
• Primary Completion: 2025-10-01
• Study Completion: 2025-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for anxiety
2. HAMA score ≥ 14 (HAMD score < 17).
3. Age range: 18-60 years.
4. Right-handed.
5. Able to cooperate with the collection of general demographic information and neuropsychological testing.
6. Patients are either medication-free or maintain a consistent medication regimen during cTBS treatment.-

Exclusion Criteria

1. Presence of organic brain lesions detected on MRI.
2. History of alcohol or drug dependence.
3. Diagnosis of other neuropsychiatric disorders, such as epilepsy, autism, obsessive-compulsive disorder, or autoimmune encephalitis.
4. Contraindications to MRI scanning.-

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale (HAMA)	0week, 1week, 3week, 5week	the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to tACS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-15)	0week, 1week, 3week, 5week	the change of somatic symptoms will be assessed by Patient Health Questionnaire (PHQ-15). PHQ-15 is composed of 15 physical symptoms that have been extracted from the PHQ. PHQ-15 scale scores range from 0 to 30 points. Higher scores indicate more severe somatic symptoms.
Self-rating anxiety scale(SAS)	0week, 1week, 3week, 5week	Self-rating anxiety scale(SAS) is a supplementary evaluation of the change of anxiety state of patients in this experiment, and it also belongs to the category of self-rating scale. Patients assessed anxiety by checking the frequency of 20 items: none or almost none, sometimes, most of the time, most of the time, or all of the time. SAS scale scores range from 0 to 100 points。The higher the score, the more serious the anxiety symptoms.
ISI(The insomnia severity index)	0week, 1week, 3week, 5week	ISI(The insomnia severity index) is used to evaluate the changes of sleep status of anxiety patients in the recent (2 weeks), which is a self-rating scale. ISI scale scores range from 0 to 28 points. The higher the score is, the worse the sleep quality is. This scale indirectly reflects the changes of patients' anxiety state through evaluation.

Trial Locations

Locations (1)

Cognitive Neuropsychology Lab Anhui Medical University; 🇨🇳 Hefei, Anhui, China