Study on the Effect and Mechanism of Transcranial Magnetic Stimulation in Multiple System Atrophy Patients With Fatigue
试验速览
- 阶段
- 不适用
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Changes in Fatigue Severity Scale-9 (FSS-9)
研究概览
简要总结
Transcranial magnetic stimulation (TMS) is a procedure that has been shown to improve fatigue in chronic sufferers. It uses a plastic covered coil that sends a magnetic pulse through the skull into the brain and by targeting particular areas in the brain it can be used to help modulate the perception of fatigue.
The study intends to use this technique to treat such a disabling symptom in patients who suffer from Multiple System Atrophy (MSA). Initially the aim is to study this technique in 22 MSA patients who are suffering from fatigue . These patients would require an resting-state funtional MRI before and after the stimulation. The stimulation would be performed ten sessions and the patients would be assessed by a clinician using well recognized clinical tools.
It is anticipated that there will be a meaningful improvement in fatigue. It is also anticipated that TMS is a safety technique to use in MSA patients . Our findings will revealed that fatigue may be associated with an altered default mode network and sensorimotor network connectivity in MSA patients. We hypothesize that these divergent motor and cognitive networks connectivity changes and their adaptive or maladaptive functional outcome may play a prominent role in the pathophysiology of fatigue in MSA.
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, Investigator)
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Multiple system atrophy diagnosed as "possible" or "probable" according to the 2008 MDS clinical diagnostic criteria;
- •Age ≥30Aged ≤ 75years old;
- •right handedness
- •the dosage and species of anti-parkinson drug is maintained during the treatment;
- •The patient or his/her legal guardian agreed to participate in the trial and signed the informed consent.Ability to follow research plans and visit plans.
排除标准
- •Serious medical and mental illness;
- •History of stroke, intracranial tumor and other central nervous system;
- •Patients with suicidal tendencies and psychotic symptoms.
- •MRI for contraindications, such as metal implants, claustrophobia, etc
- •Contraindications for TMS (such as history of seizures, pregnant women, installation of pacemakers, metal inclusions in the body, intracranial hypertension, severe bleeding tendency, etc.)
- •Patients who received TMS treatment for nearly half a year.
结局指标
主要结局
Changes in Fatigue Severity Scale-9 (FSS-9)
时间窗: Pre-treatment, post-treatment 0, 2, 4 weeks
To quantify changes of the severity of fatigue.The higher the score, the worse the fatigue.
次要结局
- Changes in Hamilton Anxiety Scale(HAMA)(Pre-treatment, post-treatment 0, 2, 4 weeks)
- Changes in 17-item Hamilton Depression Scale(HAMD-17)(Pre-treatment, post-treatment 0, 2, 4 weeks)
研究者
Piu Chan
Director
Xuanwu Hospital, Beijing