High-Frequency vs. Theta-Burst TMS in Depression: Head-to-Head Double-Blind Randomized Trial With Six-week Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Zung Self-Rating Depression Scale (SDS)
研究概览
简要总结
The goal of this clinical trial was to learn if two different types of repetitive transcranial magnetic stimulation (rTMS) could help treat depression and anxiety in adults with major depressive disorder.
The main questions it aimed to answer were:
Did high-frequency rTMS and intermittent theta-burst stimulation (iTBS) both reduce depressive symptoms? Did one treatment lead to greater improvement in anxiety symptoms?
Researchers compared people receiving high-frequency rTMS to those receiving iTBS to see if one worked better for mood and anxiety symptoms.
Participants:
Were randomly assigned to one of the two treatment groups. Received 10 stimulation sessions over two weeks (five sessions per week). Completed questionnaires and interviews on depression, anxiety, and stress before treatment, after two weeks, and again six weeks later.
详细描述
This randomized, double-blind clinical trial evaluated two established repetitive transcranial magnetic stimulation (rTMS) protocols-high-frequency rTMS (HF-rTMS) and intermittent theta-burst stimulation (iTBS)-delivered in a shortened, two-week treatment schedule for adults with major depressive disorder (MDD). The purpose was to determine whether a condensed regimen could provide effective relief of depressive and anxiety symptoms while improving treatment feasibility.
Design and Intervention A total of 108 participants with a primary diagnosis of MDD were randomized in a 1:1 ratio to receive either HF-rTMS (10 Hz stimulation) or iTBS, both targeting the left dorsolateral prefrontal cortex (DLPFC). Treatments were administered over 10 sessions in two consecutive weeks (five sessions per week).
HF-rTMS protocol: 1500 pulses per session at 10 Hz, delivered in 10 trains of 15 seconds each with 50-second inter-train intervals. Total session time: approximately 12.5 minutes.
iTBS protocol: 600 pulses per session, delivered as bursts of three 50 Hz pulses repeated at 200 ms intervals, with 2-second trains and 8-second inter-train intervals. Total session time: approximately 3 minutes and 20 seconds.
Stimulation intensity for both protocols was set at 100% of the participant's individual resting motor threshold.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study used a double-blind design. Participants were randomly assigned to receive either high-frequency rTMS or intermittent theta-burst stimulation but were not told which protocol they received. Clinical evaluators and most research staff involved in assessments were also blinded to treatment allocation. Only the technicians administering stimulation knew the protocol, and they were not involved in outcome assessments. To maintain blinding, both groups were informed that they were receiving an established rTMS treatment, and clinical raters avoided discussing protocol details with participants.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 90 years.
- •Current major depressive disorder (MDD) as the primary diagnosis, confirmed according to the International Classification of Diseases, 10th Revision (ICD-10).
- •All participants had to be evaluated by a board-certified psychiatrist trained in rTMS to confirm eligibility.
- •Ability and willingness to provide written informed consent prior to study participation.
排除标准
- •Presence of ferromagnetic or electronic implants in the head or neck (e.g., pacemakers, aneurysm clips, cochlear implants, deep brain stimulators).
- •Known seizure disorders (such as epilepsy) or significantly increased risk of seizures.
- •Other major neurological diseases or conditions that would interfere with safe rTMS administration.
- •Active psychotic symptoms or a primary psychotic disorder.
- •Acute manic episode or recent hospitalization for mania or other severe psychiatric instability.
- •Ongoing electroconvulsive therapy (ECT) treatment.
- •Medication changes made during the study.
- •Inability to comply with the treatment schedule (e.g., attendance problems, logistical barriers).
- •Any medical or psychiatric condition judged by the investigators to compromise safety or data integrity.
研究组 & 干预措施
HF-rTMS
High-frequency rTMS was delivered to the left dorsolateral prefrontal cortex using the 5 cm rule to localize the target site. Stimulation intensity was set at 100% of the resting motor threshold, determined by visible motor-evoked potentials in the right abductor pollicis brevis muscle. Each session consisted of 1500 pulses at 10 Hz, organized into 10 trains of 15 seconds (150 pulses per train) with 50-second inter-train intervals. Total stimulation time per session was approximately 12.5 minutes. A figure-of-eight coil (70BFX-LQC, Deymed Diagnostics) connected to a DuoMagXT-100 stimulator was used, with the coil positioned at ~45° from the midline, handle pointing posterolaterally.
干预措施: High-frequency repetitive transcranial magnetic stimulation (Device)
iTBS
Intermittent theta-burst stimulation (iTBS) was delivered to the left dorsolateral prefrontal cortex using the 5 cm rule for target localization. Stimulation intensity was set at 100% of the resting motor threshold, determined by motor-evoked potentials in the right abductor pollicis brevis muscle. Each session consisted of 600 pulses delivered in bursts of three 50 Hz pulses repeated every 200 ms. Trains of 2 seconds were followed by 8-second inter-train intervals. Total stimulation time per session was approximately 3 minutes and 20 seconds. A figure-of-eight coil (70HF-LQC, Deymed Diagnostics) connected to a DuoMagXT-100 stimulator was used, with coil orientation ~45° from the midline, handle pointing posterolaterally.
干预措施: Intermittent Theta Burst Stimulation (Device)
结局指标
主要结局
Zung Self-Rating Depression Scale (SDS)
时间窗: From baseline to post-treatment at 2 weeks and follow-up at 6 weeks.
A 20-item self-reported questionnaire measuring depressive symptoms. Each item is scored 1-4, yielding a total raw score range of 20-80. Standardized scores are calculated by multiplying the raw score by 1.25, with higher scores reflecting greater severity of depression (≥50 = clinically significant depression).
Hamilton Depression Rating Scale (HAMD)
时间窗: From baseline (before treatment) to post-treatment at 2 weeks and follow-up at 6 weeks.
A structured interview conducted by a trained clinician to assess severity of depressive symptoms. The HAMD contains 17-21 items scored from 0 (absent) to 2 or 4 (severe), depending on the item. The total score ranges from 0 to 52, with higher scores indicating more severe depression. Common interpretation: 0-7 = normal, 8-16 = mild depression, 17-23 = moderate, ≥24 = severe.
Beck Anxiety Inventory (BAI)
时间窗: From baseline to post-treatment at 2 weeks and follow-up at 6 weeks.
A 21-item self-reported questionnaire assessing common symptoms of anxiety. Each item is rated 0 (not at all) to 3 (severe), with a total score range of 0 to 63. Higher scores indicate more severe anxiety (0-7 = minimal, 8-15 = mild, 16-25 = moderate, 26-63 = severe).
Hamilton Anxiety Rating Scale (HAMA)
时间窗: From baseline to post-treatment at 2 weeks and follow-up at 6 weeks.
A clinician-rated scale that assesses severity of anxiety symptoms. It has 14 items, each rated from 0 (not present) to 4 (severe). The total score ranges from 0 to 56, with higher scores indicating greater anxiety (≤17 = mild, 18-24 = moderate, 25-30 = severe). Includes subscores for psychological and somatic anxiety.
次要结局
- Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR-16)(From baseline to post-treatment at 2 weeks and follow-up at 6 weeks.)
- Perceived Stress Scale (PSS)(From baseline to post-treatment at 2 weeks and follow-up at 6 weeks.)