Transcranial Magnetic Stimulation in Patients With a Depressive Episode
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to 3 months of follow up after end of stimulation regarded as reduction of symptoms measured in MADRS scale
研究概览
简要总结
The study is planned as a randomized, double-blind, active comparator-controlled and sham-controlled parallel trial, in which raters and participants will be blinded to the group selection. A total of 60 participants, meeting the eligibility criteria, will be enrolled in the study and divided randomly into 4 groups (2 experimental ones with active rTMS or iTBS and 2 controls with sham-placebo rTMS or iTBS stimaltions).
详细描述
The study is planned as a randomized, double-blind, active comparator-controlled and sham-controlled parallel trial, in which raters and participants will be blinded to the group selection. A total of 60 participants, meeting the eligibility criteria, will be enrolled in the study and divided randomly into 4 groups (2 experimental ones and 2 controls):
- EG1 (N=20) rTMS stimulation (1 session daily per 30 days, 3000 pulses per session, session time = 37,5 minutes, 10Hz),
- EG2 (N=20) iTBS stimulation (4 short sessions daily per 14 days, 600 pulses per session, session time=3 minutes, 50Hz),
- CG1 (N=10) placebo (sham-coil) stimulation based on rTMS protocol,
- CG2 (N=10) placebo (sham-coil) stimulation based on iTBS protocol. Efficacy will be analyzed on the intention-to-treat population, defined as participants who completed the baseline and at least one evaluation after rTMS intervention.
The following are the inclusion and exclusion criteria for the recruitment process:
The following stimulation protocols will be used to conduct research into the treatment of depressive disorders:
- Stimulation with rTMS within the left hemisphere, in the dorsolateral prefrontal cortex, DLPFC (Dorsolateral prefrontal cortex). In the field of stimulation, a protocol based on FDA recommendations, so- called train stimulation (stimulation of a given frequency for a short period of time with longer breaks without stimulation) assuming the following stimulation parameters:
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Psychiatric diagnosis (F3X);
- •Symptom severity - total score of the Hamilton Depression Scale a least 17
- •Granting informed consent
- •The possibility for the patient to ensure constant participation in individual sessions and clinical evaluations, in particular in terms of place of residence and travel options
- •18-70 years of age.
排除标准
- •Contraindications to treatments using TMS
- •Lack of informed consent from the patient
- •Documented persistent lack of cooperation in treatment.
结局指标
主要结局
Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to 3 months of follow up after end of stimulation regarded as reduction of symptoms measured in MADRS scale
时间窗: 3 months after end of stimulation
Comparison of efficiency of rTMS and iTBS active stimulation from baseline to 3 months follow up after end of stimualion measured with MADRS. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in HAMD scale
时间窗: END of stimulation
Comparison of efficiency of rTMS and iTBS active stimulation from baseline to end of stimualion measured with HAMD. The HAMD is a 17-items scale, measuring depression severity, the overall score ranges from 0 to 60, higher score means more severe depression.
Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to 3 months of follow up after end of stimulation regarded as reduction of symptoms measured in HAMD scale
时间窗: 3 months after end of stimulation
Comparison of efficiency of rTMS and iTBS active stimulation from baseline to 3 months follow up after end of stimualion measured with HAMD. The HAMD is a 17-items scale, measuring depression severity, the overall score ranges from 0 to 60, higher score means more severe depression.
Comparison of efficiency of rTMS and iTBS active stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in MADRS scale
时间窗: END of stimulation
Comparison of efficiency of rTMS and iTBS active stimulation from baseline to end of stimualion measured with MADRS. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Comparison of efficiency of rTMS active and rTMS sham-placebo stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in MADRS scale
时间窗: END of stimulation
Comparison of efficiency of rTMS active and rTMS sham placebo stimulation from baseline to end of stimulation measured with MADRS. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
Comparison of efficiency of rTMS active and rTMS sham placebo stimulation from baseline to end of stimulation measured with MADRS
时间窗: 3 months after end of stimulation
Comparison of efficiency of iTBS active and iTBS sham-placebo stimulation Change from Baseline to END of stimulation regarded as reduction of symptoms measured in MADRS scale. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.
次要结局
未报告次要终点