Repetitive Transcranial Magnetic Stimulation in Elderly Depressed: Neuronavegated Study
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction of the depressive symptomatology on 50% in relation to the initial scored by HAM-D/17 scale, or complete remission of the episode, defined as HAM-D/17 score ≤ 7 at the end of the treatment.
研究概览
简要总结
This double-blind, controlled and randomized study intents to investigate the antidepressive response of rTMS on the elderly population.This is the first neuronavegated pulse intensity corrected study of rTMS in elderly depressed patients.
详细描述
Most part of the studies uses samples of severe depressive patients with refractoriness and/or psychotic symptoms, which leave lacuna about the effects on depressive disorder with low or moderate scores. The literature is poor about the use of Repetitive Transcranial Magnetic Stimulation (rTMS) in the old age population.Therefore, we chose this group to research for the antidepressive effect of TMS; other interests are to identify modifications in the magnetic resonance imaging, evaluate cognitive functions and to verify the occurrence of collateral effects and safety use for this specific population.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •metallic cerebral implants
- •history of severe trauma or brain injury
- •organic brain disease
- •severe somatic disease
- •history of other psychiatric diseases
- •history of Epilepsy
- •Non cooperating patients
- •Scales and Tests of clinical evaluation:
- •Hamilton Depression Rating Scale-17 items
- •Geriatric Depression Scale (GDS)
- •Mini Mental State Examination
- •Clock Drawing Test
- •Clinical Dementia Rating
- •Visual Analogue Scale
- •Clinical Global Impression.
结局指标
主要结局
Reduction of the depressive symptomatology on 50% in relation to the initial scored by HAM-D/17 scale, or complete remission of the episode, defined as HAM-D/17 score ≤ 7 at the end of the treatment.
时间窗: 30 months
evaluation also by Geriatric Depression Scale (GDS)
次要结局
- Reduction of the depressive symptomatology on 50% in relation to the initial scored by HAM-D/17 scale, or complete remission of the episode, defined as HAM-D/17 score ≤ 7 at the end of the treatment.(30 months)