Deep rTMS in Parkinson Disease Pain Syndromes
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in baseline of Pain
研究概览
简要总结
Pain is the most prevalent non-motor symptom in Parkinson disease, and the motor improvement not always is related to the pain improvement with the medication treatment. By this, we are testing a non-invasive method called transcranial magnetic stimulation as an alternative to treat pain related to Parkinson disease. This technique can lead to either inhibitory or excitatory effects in brain circuits depending on stimulation parameters, and is known to provide analgesic effects.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parkinson disease
- •Signed term of informed consent
- •Parkinsson disease related pain
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 lacting women
- •Moderate or severe cognitive impairment
研究组 & 干预措施
deep rTMS-active doble coil
patients undergoing of deep rTMS real with doble coil
干预措施: deep rTMS (Device)
deep rTMS-sham
patients undergoing to placebo deep rTMS
干预措施: placebo deep rTMS (Device)
结局指标
主要结局
Change in baseline of Pain
时间窗: base line (moment of inclusion), day 15th, day 45th and in the last day of the sessions of rTMS (4X in two months)
assessing by Visual Analog Scale for Pain (VAS). This scale range from 0 (no pain) to 10 (maximum pain), being considered an effective improvement in the patient's pain when the pain decreases at least in 30% from the basal score.
次要结局
未报告次要终点
研究者
Daniel Ciampi Araujo de Andrade, MD, PhD
MD, PhD (Head of Pain Division)
University of Sao Paulo