Clinical Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation Based on dlPFC in the Intervention of Generalized Anxiety Disorder With Insomnia: An Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- subjective sleep quality assessed by the ISI
研究概览
简要总结
To investigate the intervention effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on insomnia symptoms of generalized anxiety disorder patients.
详细描述
Stimulation was performed using a figure 8-shaped focal coil attached to a MagPro 100 magnetic stimulator (MagVenture, Copenhagen, Denmark). All patients received 1 Hz (10 s trains, 1 s inter-train interval, 1,360 pulses per session) rTMS treatment once daily on weekdays for 2 consecutive weeks. rTMS was delivered over the right DLPFC (F4 electrode site according to the International 10-20 EEG system) at 100% of the resting motor threshold (RMT) . To determine the RMT, stimulus intensity was gradually increased until 5 out of 10 trials elicited motor evoked potentials with peak-to-peak amplitudes over 50 μV in the contralateral abductor pollicis brevis muscle. Adverse events attributed to rTMS were documented and reported. All participants received a pre-treatment assessment with the PSQI, HAMA, and HAMD. We used the PSQI to measure sleep quality, as well as HAMA and HAMD to assess participant's anxious and depressive states. Likewise, the PSQI was measured post-treatment (upon completion of the final treatment session) and at 1-month follow-up.
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)
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 15 and 65 years;
- •clinically diagnosed with anxiety according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V);
- •no previous application of any insomnia pharmacological therapy for at least one week before baseline visit.
排除标准
- •current or history of serious brain and body diseases;
- •current or history of schizophrenia, behavioral problems, post-traumatic stress disorder, mania, obsessive-compulsive disorder, and social phobia;
- •substance abuse or other comorbid psychological diseases.
研究组 & 干预措施
real stimulation
Stimulation was performed using a figure 8-shaped focal coil attached to a MagPro 100 magnetic stimulator (MagVenture, Copenhagen, Denmark). All patients received 1 Hz (10 s trains, 1 s inter-train interval, 1,360 pulses per session) rTMS treatment once daily on weekdays for 2 consecutive weeks. rTMS was delivered over the right DLPFC (F4 electrode site according to the International 10-20 EEG system) at 100% of the resting motor threshold (RMT).
干预措施: Repetitive Transcranial Magnetic Stimulation (Device)
sham stimulation
sham rTMS is carried out as the coil is turned away from the skull at 90°.
干预措施: Sham Repetitive Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
subjective sleep quality assessed by the ISI
时间窗: before and after 10-day intervention and at 1-month follow-up
The Insomnia Severity Index (ISI) is a 7-item scale to measure insomnia symptoms, where each item is rated on a scale from 0 to 4. The ISI total score ranges from 0 to 28, The higher the score indicates the more worse sleep quality.
subjective sleep quality assessed by the PSQI
时间窗: before and after 10-day intervention and at 1-month follow-up
The Pittsburgh Sleep Quality Index (PSQI) consist of 18 items divided into 7 dimensions, such as sleep duration, sleep efficiency, sleep disorders and daytime dysfunction. The PSQI total score ranges from 0 to 21, the higher the score indicates the more worse sleep quality.
emotional symptoms assessed by the HAMA
时间窗: before and after 10-day intervention and at 1-month follow-up
The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.
次要结局
- emotional symptoms assessed by the HAMD(before and after 10-day intervention and at 1-month follow-up)
研究者
Yanghua Tian
Vice President of Anhui Medical University
The Second Hospital of Anhui Medical University