Study of rTMS in the Treatment of Early/Moderate Parkinson's Disease With Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Changes in the pain caused by Parkinson's Disease as measured by Visual Analogue Scale Score.
研究概览
简要总结
Transcranial magnetic stimulation (TMS) is a procedure that has been shown to improve pain in chronic sufferers. It is a well-tolerated procedure that can be performed on an outpatient basis. 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 pain.
The study intends to use this technique to treat such a disabling symptom in patients who suffer from Parkinson's Disease (PD). Initially the aim is to study this technique in 48 patients who are suffering from pain and have PD. These patients would require an EEG before and after the stimulation. The stimulation would be performed over 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 pain. It is also anticipated that TMS is a safe technique to use in patients with PD. The study will be used to help plan a future study that compares TMS with sham technique to prove whether TMS could be an option in the treatment of such a disabling condition.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Parkinson's disease diagnosed as "clinically confirmed" or "very likely" according to the 2015 MDS clinical diagnostic criteria;
- •Age ≥ 18 Aged ≤ 80 years old;
- •PD patients with pain, exclude tumors, diabetes, osteoarthritis, rheumatoid rheumatism and other diseases, the use of analgesic drugs is not effective or insignificant.
- •After treatment with anti-Parkinson's disease drug regimen, anti-anxiety and depression, sleep drugs, analgesic drugs, etc. for ≥ 14 days, and the dosage is maintained during the treatment;
- •Ability to follow research plans and visit plans.
排除标准
- •Secondary Parkinson's syndrome caused by vascular factors, toxins, drugs, etc., or Parkinson's superposition syndrome.
- •PD patients with persistent head tremors.
- •Dementia, simple intelligent state check (mmse) ≤ 24 points.
- •Patients with suicidal tendencies and psychotic symptoms. 5, previously accepted dbs or damage surgery.
- •Contraindications for TMS (such as history of seizures, pregnant women, installation of pacemakers, metal inclusions in the body, intracranial hypertension, severe bleeding tendency, etc.)
结局指标
主要结局
Changes in the pain caused by Parkinson's Disease as measured by Visual Analogue Scale Score.
时间窗: Pre-treatment, post-treatment 0, 4 weeks
To quantify changes of the severity of pain.
次要结局
- Changes in the patient's parkinson's disease as measured by Unified Parkinson's Disease Rating Scale III(UPDRS III) score.(Pre-treatment, post-treatment 0, 4 weeks)
研究者
Piu Chan
Director
Xuanwu Hospital, Beijing