Untersuchung Von Hirnnetzwerken Durch Nicht-invasive Transkranielle Magnetstimulation - Phase 2 (PreNeSt2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- heart rate and its variability in RR slope and RMSSD values
研究概览
简要总结
The investigators compare the primary and secondary outcome measures using accelerated intermittent theta burst stimulation (aiTBS, 20 sessions active and 20 sessions sham in a counterbalanced crossover design) to treat depressive symptoms with 2 parallel arms of intervention: personalized (stimulation position based on participants' brain networks) vs conventional (stimulation in F3 position of the 10-20 EEG cap) aiTBS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between the ages of 18 and 60 years
- •Diagnosis of major depressive disorder according to DSM 5 (F32.x according to ICD-10) or bipolar disorder (bipolar I or bipolar II) according to DSM 5 (F31.x according to ICD-10) and an acute depressive condition at the time of the initial examination in outpatient or inpatient treatment (e.g. Department of Psychiatry and Psychotherapy, UMG)
- •Availability of informed consent to participate in the study, including the examinations and interventions
排除标准
- •Neurological diseases, current or previous
- •Other Axis I diagnoses that mimic the affective disorder, current or previous
- •Physical illnesses that could be related to the affective symptoms (so-called organic causes)
- •Illicit drug use in the past month
- •Substance dependence, current or previous
- •Physical illnesses which, depending on their type and severity, could interfere with the planned examinations, influence the parameters to be examined or endanger the test participant during the course of the examination
- •Medical contraindications against performing an MRT examination / rTMS application (such as metal parts in the body, e.g. implants, pacemakers, infusion pumps, metal splinters, etc.)
- •Pregnancy
- •Previously known cerebral-morphological abnormalities (e.g. tumor, lesion, etc.)
- •Evidence or history of epilepsy
- •Head trauma with a history of loss of consciousness
- •Unwillingness to be informed of incidental findings
- •Participation in an rTMS / EKT application within the last 8 weeks
- •Lack of the ability to provide informed consent
研究组 & 干预措施
Personalized aiTBS active - sham
counterbalanced crossover with sham neuronavigated stimulation
干预措施: Neuronavigated aiTBS (Device)
Conventional (F3) aiTBS active - sham
counterbalanced crossover with sham neuronavigated stimulation
干预措施: Neuronavigated aiTBS (Device)
结局指标
主要结局
heart rate and its variability in RR slope and RMSSD values
时间窗: 4-6 weeks
Potential marker of treatment response
Montgomery-Åsberg Depression Rating Scale (MADRS scores in units of scale)
时间窗: 6 weeks
Administer Rating Scale
次要结局
- Hamilton Rating Scale for Depression (HAMD-17 scores in units of scale)(6 weeks)
- epi / genetic markers of neuroplasticity in ng(5-6 weeks)
- DMN decoupling / other networks in rho and z values(4-6 weeks)
- Beck Depression Inventory (BDI-2 scores in units of scale)(6 weeks)
研究者
PD Dr. Roberto Goya-Maldonado
Principal Investigator
University Medical Center Goettingen