Effects of Repetitive Transcranial Magnetic Stimulation on Heart Rate Variability
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Heart rate variability changes
研究概览
简要总结
Repetitive transcranial magnetic stimulation is a non-invasive neuromodulation technique used to treat different neuropsychiatric disorders, such as, depression, neuropathic pain, fibromyalgia and obsessive-compulsive disorder. It is known that the heart rate variability is altered in these conditions. Therefore the focus of this research is to show the influence of rTMS on the Heart Rate Variability.
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
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agreed participate the protocol
- •Signing the consent form
- •Do not present any cardiac problems or disease
排除标准
- •Trauma of Skull, epilepsy don't treated,
- •Use of medications decrease the seizure threshold
- •Patients in use of drugs, how cocaine and alcohol
- •Neurosurgical clips, pacemakers, increased intracranial pressure (risk of sequelae after seizure)
- •Pregnant or breastfeeding women
研究组 & 干预措施
rTMS-PSI
Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the posterior superior insula right.
干预措施: Repetitive transcranial magnetic stimulation (Procedure)
rTMS-M1
Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the right primary motor cortex.
干预措施: Repetitive transcranial magnetic stimulation (Procedure)
rTMS-F3
Participants allocated in this arm will receive active repetitive transcranial magnetic stimulation over the left pre frontal dorsolateral cortex.
干预措施: Repetitive transcranial magnetic stimulation (Procedure)
结局指标
主要结局
Heart rate variability changes
时间窗: Three times during the entire study. Following the scheme, Until 1 hour before each session, 15 minutes along the each session and until 1 hour after the end of session
Changes in heart rate variability measured by Polar V800
次要结局
- Volume in(1 week before the first session of stimulation)
- Conditioned Pain Modulation(48 hours before the first session of stimulation)
研究者
Ricardo Galhardoni
assistant professor, Clinical Research
University of Sao Paulo