"A Clinical Study on the Effectiveness of Accelerated Transcranial Magnetic Stimulation (TMS) in the Treatment of Depressive Episode."
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Remission of Depression will be assessed
研究概览
简要总结
This study will be a longitudinal interventional study that involves patients satisfying all the inclusion criteria.
All patients who match the inclusion criteria will be assessed for severity of depression according to ICD 10 criteria.
Patients having first episode mild and moderate depressive episode will be treated according to the standard accelerated Theta Burst Stimulation Protocol
Patients will be assessed with HDRS scale before the treatment and after 5th session and at the end of final session.
All patients will receive the accelerated iTBS protocol for depression which consists of three magnetic pulses delivered 20 ms apart and repeatedly delivered every 200 ms resulting in a 5 Hz theta rhythm over the left DLPFC area.
Intensity will be set to 120% motor threshold (MT), and a total of 3600 pulses will be delivered per day, two sessions of 2000 pulses each with 30 min interval lasting roughly 13 min. Total 20 sessions on 10 consecutive days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients willing and able to give written informed consent.
- •Patients of all ages 18 to 60 diagnosed with mild depressive episode and moderate depressive episode for the first time, being treated under psychiatry department KIMS Hubli.
排除标准
- •Patients who refuse to consent for the study Patients less than 18 years or above 60 years Patients with severe depressive episode Medical comorbidities such as epilepsy, vascular, traumatic, tumoral, infectious, or metabolic lesion of the brain, severe or recent heart disease Pregnancy  Patients who have implanted ferromagnetic devices or other magnetic-sensitive metal.
结局指标
主要结局
Remission of Depression will be assessed
时间窗: Remission will be assessed at the end of 5th session and 10th session
次要结局
- How long the remission lasts will be assessed(The patient will be assessed one month after the initial session)
研究者
Dr Niharika H S
Karnataka Institute of Medical Sciences Hubli