Stanford Neuromodulation Therapy (SNT) for Non-suicidal Self-injury (NSSI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Adolescent Non-suicidalself-injury Assessment Questionnaire
研究概览
简要总结
To investigate the treatment effect of Stanford Neuromodulation Therapy (SNT) on patients with Non-suicidal Self-injury (NSSI) and the underlying neural mechanism.
详细描述
This was a open-label clinical trial to assess the efficacy and underlying neural mechanism of SNT among patients with NSSI.
80 patients with NSSI diagnosed by DSM-5 were recruited from the Second Hospital of Anhui Medical University. After meeting the inclusion criteria and obtaining informed consent, All the participants were randomized (1:1) into two groups: SNT group and rTMS group.
Before the treatment, the Adolescent Non-suicidal Self-injury Assessment Questionnaire (ANSAQ) was obtained by a trained investigator to assess baseline severity. The patients had receiving a battery measure of neuropsychological tests(Hamilton depression/anxiety scale, Health Questionnaire-15) and magnetic resonance imaging (MRI) scan in multimodalities.
For SNT group, the treatment was performed once a day for 5 consecutive days. A Brainsight neuronavigation system was used to position the TMS coil over the individualized stimulation target at each session. Ten sessions of iTBS were delivered daily, for a total of 18,000 pulses per day. Stimulation was delivered at 90% of resting motor threshold (rMT).
For rTMS group, the treatment was also performed once a day for 5 consecutive days. Two sessions of rTMS were delivered daily. Each rTMS session comprised 100 trains of 4s duration at 10 Hz with inter-train intervals of 26 s (i.e., 4000 pulses per session). Stimulation was delivered at 90% of rMT.
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
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients were diagnosed by 2 or more senior clinical psychiatrists, meeting DSM-V criteria, and having 1 or more non-suicidal self-injurious behaviors in the last 6 months
- •12-18 years of age
- •The medicine has not changed in the 4 weeks prior to or after this study, and if it has to be changed, the treatment medication is required to be at a subtherapeutic dosage level
排除标准
- •the patients has suicidal ideation, or have committed suicidal behavior
- •T1 or T2 weighted phase magnetic resonance images show focal brain lesions
- •patients had neurological disorders such as epilepsy, or serious physical illnesses
- •patients had history of substance abuse and drug dependence in the last 6 months or use of anticonvulsant drugs in the last 3 months
- •patiens had received radial cranial electrical stimulation or magnetic stimulation treatment in the last 3 months, or received electroconvulsive therapy in the last 6 months
- •patients had previous significant head trauma or with EEG abnormality in the last 1 month
- •body-mounted devices unsuitable for treatment, such as pacemakers, artificial valves and other metal implants.
研究组 & 干预措施
SNT Group
Patients will be treated with neuronavigated transcranial magnetic stimulation. The treatment protocol is 90% motor threshold (RMT) stimulation intensity for 60 cycles of 10 triplet pulses each at a frequency of 50 Hz, in 2-second stimulation sequences (5 Hz) with 8-second intervals. Stimulation treatments were performed hourly. Ten treatments per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses total).
干预措施: Transcranial Magnetic Stimulation (Device)
rTMS Group
Patients will be treated with the normal non-neuronavigated transcranial magnetic stimulation. The treatment protocol is 90%-100% RMT stimulation intensity; 10 Hz frequency for 4 seconds with 26 seconds of rest; 4,000 pulses per session; total duration 50 minutes, twice daily (8,000 pulses/day) for 5 days (40,000 pulses total).
干预措施: Transcranial Magnetic Stimulation (Device)
结局指标
主要结局
Adolescent Non-suicidalself-injury Assessment Questionnaire
时间窗: baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention)
The questionnaire consisted of 2 dimensions and 12 items, with 5 options for each item, namely, "none, occasional, sometimes, often and always", and was scored on a 5-point Likert scale from 0 to 4. The score for each item was summed up as the total score of the questionnaire, and the total mean score was divided by the number of items. The total mean score was divided by the number of items, and the higher the total mean score, the more serious the patients' non-suicidal Likert 5 self-injurious behaviors were.
次要结局
- Hamilton Depression Rating Scale (HAMD) Score(baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention))
- Patient Health Questionnaire-15 (PHQ-15) scale(baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention))
- Hamilton Anxiety Scale (HAMA) Score(baseline, the second day(immediately after the intervention),the seventh day(immediately after the intervention))
研究者
WANG KAI
Head, Dept of Neurology & Medical Psychology, Director, Cognitive Neuropsychology Lab, PRC
Anhui Medical University