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MRI-Guided Accelerated cTBS for Generalized Anxiety Disorder

2026년 6월 9일 업데이트: Yumeng Ju, Central South University

Efficacy and Neural Mechanisms of MRI-Guided Accelerated Continuous Theta Burst Stimulation Targeting the Inferior Parietal Lobule in Generalized Anxiety Disorder: A Randomized Controlled 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

Generalized Anxiety Disorder (GAD) is one of the most prevalent psychiatric disorders worldwide and is characterized by excessive and persistent anxiety, impaired psychosocial functioning, and reduced quality of life. Despite the availability of pharmacological and psychological treatments, a substantial proportion of patients continue to experience clinically significant symptoms. Pharmacological therapies often require several weeks before therapeutic benefits emerge, while access to evidence-based psychotherapies remains limited in many settings. Therefore, there is a critical need for novel interventions capable of producing rapid and durable anxiolytic effects.

Transcranial magnetic stimulation (TMS) has emerged as a promising non-invasive neuromodulation technique for the treatment of psychiatric disorders. Continuous theta-burst stimulation (cTBS), a patterned form of repetitive TMS, substantially reduces treatment duration while maintaining efficacy and safety comparable to conventional repetitive TMS protocols. Previous studies have demonstrated therapeutic benefits of cTBS in patients with anxiety disorders; however, conventional treatment courses typically extend over several weeks and may not achieve rapid symptom relief. Accelerated stimulation protocols involving multiple daily treatment sessions over a short period have shown encouraging clinical effects in other psychiatric populations, suggesting potential applicability to anxiety disorders.

Neuroimaging studies have identified the right intraparietal sulcus (IPS) as a key cortical region involved in attentional control, vigilance, salience processing, and anxiety-related arousal. Functional interactions between the IPS and the amygdala are thought to play an important role in regulating emotional and anxiety-related processes. Individual variability in these neural circuits may contribute to heterogeneity in treatment response. Consequently, personalized stimulation targeting based on functional neuroimaging may improve therapeutic outcomes compared with conventional fixed-target approaches.

The present study aims to investigate the efficacy and safety of precision-targeted accelerated cTBS guided by individualized IPS-amygdala functional connectivity in patients with GAD and to explore potential neurobiological mechanisms underlying treatment response. Participants who meet ICD-11 diagnostic criteria for GAD will be randomly assigned in a 1:1:1 ratio to one of three intervention groups: a precision cTBS group, a non-precision cTBS group, or a sham stimulation group.

All participants will receive accelerated cTBS treatment for 5 consecutive days, with five stimulation sessions per day. Each session will deliver 1800 pulses, resulting in a total of 9000 pulses per day, with 50-minute intervals between sessions. Stimulation intensity will be set at 80%-120% of the resting motor threshold. In the precision cTBS group, baseline functional MRI data will be used to identify the right IPS coordinate exhibiting the strongest functional connectivity with the right basolateral amygdala (BLA), and stimulation will be delivered using neuronavigation-guided targeting. In the non-precision cTBS group, stimulation will target a fixed right parietal cortical projection coordinate corresponding to the P4 site reported in previous cranio-cerebral correlation studies of the international 10-20 EEG system. Participants in the sham group will undergo identical procedures using a sham coil.

The primary outcome measure is the change in the total score of the Hamilton Anxiety Rating Scale (HAMA) from baseline to day 5. Secondary outcomes include clinical response and remission rates, changes in relevant clinical symptoms, adverse events occurring during treatment, and neuroimaging indicators. Assessments will be conducted at baseline, during treatment, and at week 2, month 1, and month 2 from baseline to evaluate short-term and sustained treatment effects.

연구 유형

중재적

등록 (추정된)

75

단계

  • 해당 없음

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  • 성인
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건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • 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.
  • Able to receive anti-anxiety treatment during the follow-up period according to the instructions of outpatient or inpatient physicians.
  • Hamilton Anxiety Rating Scale (HAMA) score ≥14 and Patient Health Questionnaire-15 (PHQ-15) score ≥5.

Exclusion Criteria:

  • 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.
  • Clinically significant sensory impairments that cannot be corrected, such as color blindness or hearing impairment.
  • Pregnant or breastfeeding women.
  • Positive urine drug screen.
  • Abnormal thyroid function tests.
  • Personal history of epilepsy or family history of epilepsy.
  • Receipt of physical therapy within the past six months, such as repetitive transcranial magnetic stimulation or electroconvulsive therapy.
  • Suspected or confirmed history of alcohol or drug dependence.
  • Use of anticoagulants, such as heparin or warfarin, corticosteroids, or thyroid disease treatments within the past three months.
  • Current use of psychoactive medications.
  • Receipt of neurocognitive assessments similar to those used in this study within the past 12 months.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Precision cTBS stimulation group
Undergo precise targeted accelerated cTBS guided by individual right IPS-right BLA functional connectivity. The individual IPS target is located using the Visor2 neuronavigation system, with treatment administered continuously for 5 days, 5 times per day, each session lasting 120 seconds with 1800 pulses, and an interval of 50 minutes between sessions.
장치: continuous theta burst stimulation(cTBS)
Accelerated 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.
실험적: Non-precise cTBS stimulation group
Receive non-individualised target cTBS. Use the cortical target corresponding to the P4 site of the international 10-20 EEG system as the stimulation target, with the remaining equipment, stimulation intensity, frequency, treatment course, number of pulses per session, and treatment procedures consistent with the precise cTBS group.
장치: continuous theta burst stimulation(cTBS)
Accelerated 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.
가짜 비교기: Sham stimulation group
Receive sham cTBS. Apart from using a sham coil with no effective magnetic field output, the coil placement, neuronavigation procedure, number of treatments, treatment duration, and follow-up process are consistent with the precise cTBS group.
장치: continuous theta burst stimulation(cTBS)
Accelerated 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline to Day 5
기간: Baseline and Day 5 (End of Treatment)
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.
Baseline and Day 5 (End of Treatment)

2차 결과 측정

결과 측정
측정값 설명
기간
Clinical Response Rate
기간: Day 3, Day 5, Week 2, Month 1, and Month 2 from baseline
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.
Day 3, Day 5, Week 2, Month 1, and Month 2 from baseline
Clinical Remission Rate
기간: Day 3 , Day 5 , Week 2, Month 1, and Month 2 from baseline
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.
Day 3 , Day 5 , Week 2, Month 1, and Month 2 from baseline
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score From Baseline
기간: Baseline, Day 3, Week 2, Month 1, and Month 2
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.
Baseline, Day 3, Week 2, Month 1, and Month 2
Change in 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score From Baseline
기간: Baseline, Day 3, Day 5, Week 2, Month 1, and Month 2 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.
Baseline, Day 3, Day 5, Week 2, Month 1, and Month 2 from baseline
Change in Beck Scale for Suicide Ideation (BSI) Score From Baseline
기간: Baseline and Day 5 (End of Treatment)
Suicidal ideation will be assessed using the Beck Scale for Suicide Ideation (BSI), a 19-item scale with a total score range of 0 to 38. Higher scores indicate more severe suicidal ideation, which represents a worse outcome. The outcome will be calculated as the change in BSI score from baseline to Day 5.
Baseline and Day 5 (End of Treatment)
Change in Generalized Anxiety Disorder-7 (GAD-7) Score From Baseline
기간: Baseline, Day 3, Day 5, Week 2 and Month 1 from baseline
Anxiety symptom severity will be assessed using the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report questionnaire with a total score range of 0 to 21. Higher scores indicate greater anxiety symptom severity, which represents a worse outcome. The outcome will be calculated as the change in GAD-7 score from baseline to each post-baseline assessment time point.
Baseline, Day 3, Day 5, Week 2 and Month 1 from baseline
Change in Patient Health Questionnaire-15 (PHQ-15) Score From Baseline
기간: Baseline, Day 3, Day 5, Week 2 and Month 1 from baseline
Somatic symptom severity will be assessed using the Patient Health Questionnaire-15 (PHQ-15), a 15-item self-report questionnaire with a total score range of 0 to 30. Higher scores indicate greater somatic symptom severity, which represents a worse outcome. The outcome will be calculated as the change in PHQ-15 score from baseline to each post-baseline assessment time point.
Baseline, Day 3, Day 5, Week 2 and Month 1 from baseline
Change in Patient Health Questionnaire-9 (PHQ-9) Score From Baseline
기간: Baseline, Day 3, Day 5, Week 2 and Month 1 from baseline
Depressive symptom severity will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report questionnaire with a total score range of 0 to 27. Higher scores indicate greater depressive symptom severity, which represents a worse outcome. The outcome will be calculated as the change in PHQ-9 score from baseline to each post-baseline assessment time point.
Baseline, Day 3, Day 5, Week 2 and Month 1 from baseline
Change in Pittsburgh Sleep Quality Index (PSQI) Score From Baseline
기간: Baseline and Day 5 (End of Treatment)
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a self-report questionnaire with a global score range of 0 to 21. Higher scores indicate poorer sleep quality, which represents a worse outcome. The outcome will be calculated as the change in PSQI global score from baseline to Day 5.
Baseline and Day 5 (End of Treatment)
Change in Penn State Worry Questionnaire (PSWQ) Score From Baseline
기간: Baseline and Day 5 (End of Treatment)
Worry severity will be assessed using the Penn State Worry Questionnaire (PSWQ), a 16-item self-report questionnaire with a total score range of 16 to 80. Higher scores indicate greater worry severity, which represents a worse outcome. The outcome will be calculated as the change in PSWQ score from baseline to Day 5.
Baseline and Day 5 (End of Treatment)
Change in Intolerance of Uncertainty Scale (IUS) Score From Baseline
기간: Baseline and Day 5 (End of Treatment)
Intolerance of uncertainty will be assessed using the Intolerance of Uncertainty Scale (IUS), a 27-item self-report questionnaire with a total score range of 27 to 135. Higher scores indicate greater intolerance of uncertainty, which represents a worse outcome. The outcome will be calculated as the change in IUS score from baseline to Day 5.
Baseline and Day 5 (End of Treatment)
Change in Cognitive Test Performance From Baseline to Day 5
기간: Baseline and Day 5 (End of Treatment)
Cognitive function will be assessed using neurocognitive tests administered in this study. The score range depends on the specific cognitive test or task. For accuracy-based cognitive measures, higher scores indicate better cognitive performance, which represents a better outcome; for time-based measures such as reaction time, higher values indicate slower performance, which represents a worse outcome. The outcome will be calculated as the change in cognitive test performance from baseline to Day 5.
Baseline and Day 5 (End of Treatment)
Change in State-Trait Anxiety Inventory (STAI) Score From Baseline
기간: Baseline and Day 5 (End of Treatment)
Anxiety symptoms and anxiety proneness will be assessed using the State-Trait Anxiety Inventory (STAI), a 40-item self-report questionnaire consisting of the State Anxiety and Trait Anxiety subscales. Each subscale has a score range of 20 to 80. Higher scores indicate greater anxiety, which represents a worse outcome. The outcome will be calculated as the change in STAI score from baseline to Day 5.
Baseline and Day 5 (End of Treatment)
Change in Perceived Stress Scale-10 (PSS-10) Score From Baseline
기간: Baseline and Day 5 (End of Treatment)
Perceived stress will be assessed using the Perceived Stress Scale-10 (PSS-10), a 10-item self-report questionnaire with a total score range of 0 to 40. Higher scores indicate higher perceived stress, which represents a worse outcome. The outcome will be calculated as the change in PSS-10 score from baseline to Day 5.
Baseline and Day 5 (End of Treatment)
Change in Ruminative Responses Scale (RRS) Score From Baseline
기간: Baseline and Day 5 (End of Treatment)
Rumination will be assessed using the Ruminative Responses Scale (RRS), a 22-item self-report questionnaire with a total score range of 22 to 88. Higher scores indicate greater rumination, which represents a worse outcome. The outcome will be calculated as the change in RRS score from baseline to Day 5.
Baseline and Day 5 (End of Treatment)
Change in Anxiety and Depression Visual Analogue Scale Scores From Baseline
기간: Baseline, Day 1, Day 3, Day 5 and Week 2 from baseline
Subjective anxiety and depression severity will be assessed using visual analogue scale ratings for anxiety and depression. Each visual analogue scale score ranges from 0 to 10, with higher scores indicating greater subjective symptom severity, which represents a worse outcome. The outcome will be calculated as the change in visual analogue scale scores from baseline to each post-baseline assessment time point.
Baseline, Day 1, Day 3, Day 5 and Week 2 from baseline
Treatment-Emergent Side Effects During the Intervention and Follow-up Period
기간: Day 1, Day 3, Day 5 and Week 2 from baseline
Treatment-emergent side effects will be assessed using a physical treatment side-effect assessment that records the presence, type, severity, and relationship to the study intervention of adverse events. This outcome will be summarized as the occurrence and severity of treatment-emergent side effects during the intervention and follow-up period; higher severity indicates a worse safety outcome.
Day 1, Day 3, Day 5 and Week 2 from baseline
Change in Heart Rate Variability From Baseline to Day 5
기간: Baseline and Day 5 (End of Treatment)
Heart rate variability will be assessed to evaluate autonomic nervous system function. Heart rate variability parameters may include time-domain and frequency-domain measures such as the standard deviation of normal-to-normal intervals and the root mean square of successive differences. The expected range depends on the specific heart rate variability parameter. In general, higher heart rate variability reflects better autonomic flexibility and may represent a better physiological outcome. The outcome will be calculated as the change in heart rate variability measures from baseline to Day 5.
Baseline and Day 5 (End of Treatment)
Change in Magnetic Resonance Imaging Measures From Baseline to Day 5
기간: Baseline and Day 5 (End of Treatment)
Brain structural and/or functional measures will be assessed using magnetic resonance imaging. The specific values and ranges depend on the imaging modality and derived measure, such as structural, functional connectivity, or brain network metrics. Interpretation will depend on the specific magnetic resonance imaging measure analyzed. The outcome will be calculated as the change in magnetic resonance imaging measures from baseline to Day 5.
Baseline and Day 5 (End of Treatment)
Dysfunctional Attitudes Scale (DAS) Score at Baseline
기간: Baseline
Dysfunctional attitudes will be assessed using the Dysfunctional Attitudes Scale (DAS), a 40-item self-report scale with a total score range of 40 to 280. Higher scores indicate more dysfunctional attitudes, which represents a worse psychological profile. This measure will be assessed at baseline.
Baseline
Childhood Trauma Questionnaire (CTQ) Score at Baseline
기간: Baseline
Childhood trauma exposure will be assessed using the Childhood Trauma Questionnaire (CTQ), a 25-item self-report questionnaire with a total score range of 25 to 125. Higher scores indicate greater childhood trauma exposure, which represents a worse psychosocial profile. This measure will be assessed at baseline.
Baseline

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Central South University

수사관

  • 연구 의자: Yan Zhang, PhD, Second Xiangya Hospital of Central South University
  • 수석 연구원: Yumeng Ju, PhD, Second Xiangya Hospital of Central South University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 6월 1일

기본 완료 (추정된)

2027년 1월 1일

연구 완료 (추정된)

2027년 2월 1일

연구 등록 날짜

최초 제출

2026년 5월 28일

QC 기준을 충족하는 최초 제출

2026년 6월 9일

처음 게시됨 (실제)

2026년 6월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • KYZ20240157

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

continuous theta burst stimulation(cTBS)에 대한 임상 시험

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약물 개입

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스폰서 / 협력자

위치

구독하다