MRI-Guided Accelerated cTBS for Generalized Anxiety Disorder
ConditionGeneralized Anxiety Disorder (GAD)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentral South University
About this trial
Generalized Anxiety Disorder (GAD) is a common psychiatric disorder associated with persistent anxiety, functional impairment, and incomplete response to existing treatments. Although transcranial magnetic stimulation (TMS) has shown therapeutic potential in anxiety disorders, conventional treatment schedules often require several weeks and may not provide sufficiently rapid symptom relief. This study aims to evaluate the efficacy and safety of precision-targeted accelerated continuous theta-burst stimulation (cTBS) guided by individualized functional connectivity between the intraparietal sulcus (IPS) and the amygdala in patients with GAD.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Outpatients or inpatients at the Second Xiangya Hospital who are confirmed by two experienced psychiatrists to meet the International Classification of Diseases 11th Revision (ICD-11) diagnostic criteria for generalized anxiety disorder.
Aged 18 to 65 years, regardless of gender.
Right-handed.
Junior high school education or above, with the ability to provide informed consent and complete cognitive assessments.
Disqualifiers
Presence of psychotic symptoms.
Diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, current psychiatric symptoms, or post-traumatic stress disorder based on SCID-5 assessment, either currently or within the past year.
Organic brain disease or severe somatic diseases, such as thyroid disease, lupus, diabetes, lung disease, liver disease, kidney disease, infection, or major trauma.
Intracranial implants.
Trial design
Design model
Parallel
Treatments tested in this trial
continuous theta burst stimulation(cTBS)
DeviceAccelerated cTBS treatment was administered over 5 days, five times daily (1800 pulses per session, a total of 9000 pulses per day, with 50-minute intervals between sessions), at a stimulation intensity of 80%-120% of the resting motor threshold. The precise stimulation group targeted locations based on individual baseline functional MRI data, calculating the coordinates of strongest functional connectivity between the right IPS and the right basolateral amygdala (BLA), and implemented via neuronavigation system registration; the non-precise stimulation group targeted the cortical projection coordinates of the P4 electrode site according to the international 10-20 EEG system; the sham stimulation group used the same parameters but with a sham coil.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Precision cTBS stimulation groupExperimental treatment 1 intervention
Group B: Non-precise cTBS stimulation groupExperimental treatment 1 intervention
Group C: Sham stimulation groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Day 5
Anxiety symptom severity will be assessed using the Hamilton Anxiety Rating Scale (HAMA), a 14-item clinician-administered scale with a total score range of 0 to 56. Higher scores indicate greater anxiety symptom severity, which represents a worse outcome. The outcome will be calculated as the change in HAMA total score from baseline to Day 5.
Time frame
Baseline and Day 5 (End of Treatment)Secondary outcomes
1
Clinical Response Rate
Clinical response will be assessed using the Hamilton Anxiety Rating Scale (HAMA), a 14-item clinician-administered scale with a total score range of 0 to 56. Higher scores indicate greater anxiety symptom severity, which represents a worse outcome. Clinical response is defined as a reduction of at least 50% in HAMA total score compared with baseline.
Time frame
Day 3, Day 5, Week 2, Month 1, and Month 2 from baseline2
Clinical Remission Rate
Clinical remission will be assessed using the Hamilton Anxiety Rating Scale (HAMA), a 14-item clinician-administered scale with a total score range of 0 to 56. Higher scores indicate greater anxiety symptom severity, which represents a worse outcome. Clinical remission is defined as a HAMA total score of 7 or less at the corresponding assessment time point.
Time frame
Day 3 , Day 5 , Week 2, Month 1, and Month 2 from baseline3
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline
Anxiety symptom severity will be assessed using the Hamilton Anxiety Rating Scale (HAMA), a 14-item clinician-administered scale with a total score range of 0 to 56. Higher scores indicate greater anxiety symptom severity, which represents a worse outcome. The outcome will be calculated as the change in HAMA total score from baseline to each post-baseline assessment time point.
Time frame
Baseline, Day 3, Week 2, Month 1, and Month 24
Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score From Baseline
Depressive symptom severity will be assessed using the 17-item Hamilton Depression Rating Scale (HAMD-17), a clinician-administered scale with a total score range of 0 to 52. Higher scores indicate greater depressive symptom severity, which represents a worse outcome. The outcome will be calculated as the change in HAMD-17 total score from baseline to each post-baseline assessment time point.
Time frame
Baseline, Day 3, Day 5, Week 2, Month 1, and Month 2 from baselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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