The Effect of Long-term Treatment of Parkinson's Disease With T-PEMF
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- Sit-to-stand
研究概览
简要总结
The goal of this clinical trial is to learn to what extent daily stimulation of the brain with transcranial pulsed electromagnetic fields (T-PEMF) works to treat persons with Parkinson's Disease. The main questions it aims to answer are:
- How does 6 months of daily treatment (30 minutes/day) with T-PEMF affects neuro-mechanical and molecular biological factors compared with placebo treatment in persons with Parkinson's disease?
- How does 12 months of daily treatment (30 minutes/day) with T-PEMF affects neuro-mechanical and molecular biological factors in persons with Parkinson's disease an does 12 months of T-PEMF alters the need for medication intake?
The neuro-mechanical outcomes are compared with the "natural" progression of the disease as well as with a healthy reference group. Furthermore, it will be examined whether 12 months of T-PEMF treatment alters the need for medication intake.
Participants in the intervention group will:
- receive one 30 min treatment session daily for 12 months
- receive either T-PEMF or sham treatment for the first 6 months
- receive active T-PEMF treatment the last 6 months
- visit for tests before treatment initiation, after 6 months of treatment and after 12 months of treatment.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Masking only applies to the intervention groups. The control group and reference group are Open Label.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Intervention Groups
- •Inclusion Criteria:
- •Diagnosed with idiopathic Parkinson's disease
- •The participant must be able to understand, accept, and complete the planned procedures
- •Parkinson's symptoms in the medicated state must correspond to Hoehn & Yahr stage 1 or 2
- •Mini Mental-State Examination score > 22
排除标准
- •Cancer in the brain, neck, or head area
- •Presence of active medical implants
- •Alcoholism
- •Substance abuse
- •Open wound on the scalp
- •Severe psychopathological disorders
- •Pregnancy
- •Changes in pharmacological anti-Parkinson medication within the last 6 weeks prior to the start of T-PEMF treatment
- •Anticoagulant treatment with Marevan, Marcoumar, Pradaxa, Eliquis, Xarelto, Lixiana, Novostan, Fragmin, or Innohep
- •Neurological disease other than Parkinson's disease
- •Previous stroke
- •Reduced motor function caused by conditions other than Parkinson's disease
- •Control Group with Parkinson's Disease
- •Inclusion Criteria:
- •Diagnosed with idiopathic Parkinson's disease
- •The patient must be able to understand, accept, and complete the planned procedures
- •Parkinson's symptoms in the medicated state must correspond to Hoehn & Yahr stage 1 or 2
- •Mini Mental-State Examination score > 22
- •Exclusion Criteria:
- •Neurological disease other than Parkinson's disease
- •Reduced motor function caused by conditions other than Parkinson's disease
- •Healthy Reference Group:
- •Inclusion Criteria:
- •The patient must be able to understand, accept, and complete the planned procedures
- •Exclusion Criteria:
- •Neurological disease
- •Reduced motor function caused by condition
研究组 & 干预措施
Intervention group 1: Full T-PEMF
Persons with Parkinson's disease receiving 30 min daily active T-PEMF for 12 months. The first 6 months are blinded, the last 6 months are not.
干预措施: Transcranial pulsed electromagnetic fields (T-PEMF) (Device)
Intervention group 2: sham + T-PEMF
Persons with Parkinson's disease receiving 30 min daily sham T-PEMF for 6 months followed by 6 moths of 30 min daily active T-PEMF. The first 6 month is blinded, the last 6 months are not.
干预措施: Transcranial pulsed electromagnetic fields (T-PEMF) (Device)
Intervention group 2: sham + T-PEMF
Persons with Parkinson's disease receiving 30 min daily sham T-PEMF for 6 months followed by 6 moths of 30 min daily active T-PEMF. The first 6 month is blinded, the last 6 months are not.
干预措施: Sham (No Treatment) (Device)
Control group
Persons with Parkinson's disease receiving no experimental treatment. The group is used to monitor natural course of the disease.
Healthy reference group
Health age-matched persons assessed once to obtain age-matched normal intervals of performance.
结局指标
主要结局
Sit-to-stand
时间窗: From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.
Completion time of 5 repetition sit-tot-stand test at maximal speed performed on force plate.
次要结局
- Rate of force development(From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.)
- Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.)
- Tremor intensity(From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months.)
- Cerebrospinal fluid biomarkers(From enrollment to end of intervention assessed at baseline, after 6 months and after 12 months. Assessment in the intervention groups only.)