Transcranial Low Voltage Pulsed Electromagnetic Fields (T-PEMF) in Patients With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Change from baseline in Unified Parkinson´s Disease Rating Scale (UPDRS)
研究概览
简要总结
The aim of this study, is to determine whether treatment using transcranial low voltage pulsed electromagnetic fields (T-PEMF) can reduce the symptoms patients with Parkinson's Disease (PD) experience. The symptoms include movement, mentality and the nervous system in general.
Furthermore the purpose of this study is to clarify whether a group of patients with PD, gain a statistical improvement in their symptoms when treated with active T-PEMF, compared to a group of patients with PD who receive placebo T-PEMF .
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Idiopathic Parkinson's disease H & Y 1-3 (Hoehn&Yahr)
- •MMSE > 22 (a screening test for dementia). (MMSE - Mini-Mental State Examination)
- •Age > 18 years.
- •The patient is capable understanding, accepting and complete the planned procedures.
排除标准
- •The patient has been using T-PEMF before.
- •Changes in anti-parkinson drug treatment within the last 6 weeks
- •Noticeable dementia or other brain injury, which may affect the ability to give consent, or complicates the assessment of the patient
- •Psychosis, or other psychopathological conditions, which requires intervention
- •The abuse of alcohol or drugs
- •Treatment with Deep Brain stimulation.
- •Pregnancy or nursing
- •Epilepsy.
- •Active implants such as pacemakers and others for example cochlear implants
- •Active medical device for example insulin pumps, baclofen pumps.
- •Participation in other trials in the intervention period
- •Current or previous history of brain tumors, leukemia, malignant melanoma, skin cancer, or head and neck cancer
- •Autoimmune disease
- •Wounds in the scalp
结局指标
主要结局
Change from baseline in Unified Parkinson´s Disease Rating Scale (UPDRS)
时间窗: At baseline and at endpoint at week 8.
Comment on "Title": It is expected that the outcome measure UPDRS will report a change after 8 weeks of treatment compared to baseline. Comment on "Time Frame": Data will be assessed at each group after 8 weeks, and will be presented when all included patients have received their intervention.
次要结局
未报告次要终点
研究者
Bo Mohr Morberg
MD, Ph.D. student
Odense University Hospital