Clinical trial NCT06699706: Neuroimage-guided Dual-target Continuous Theta Burst Stimulation for Generalized Anxiety Disorder
Official title: Neuroimage-guided Dual-target Continuous Theta Burst Stimulation for Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Transcranial Magnetic Stimulation Repetitive
Keywords: Transcranial Magnetic Stimulation
anxiety
neuroimage
Lead sponsor: Anhui Medical University
Sponsor class: OTHER
First posted: 2024-11-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.-

Primary outcomes:
measure: Hamilton Anxiety Rating Scale (HAMA)
timeFrame: 0week, 1week, 3week, 5week
Secondary outcomes:
measure: Patient Health Questionnaire (PHQ-15)
timeFrame: 0week, 1week, 3week, 5week
measure: Self-rating anxiety scale(SAS)
timeFrame: 0week, 1week, 3week, 5week
measure: ISI(The insomnia severity index)
timeFrame: 0week, 1week, 3week, 5week
Other outcomes:
Locations:
city: Hefei
country: China
facility: Cognitive Neuropsychology Lab Anhui Medical University
state: Anhui
Study officials:
References: